Loi sur les biens thérapeutiques n° 21 de 1989, (version consolidée du 11 Décembre 2012), Australie, WIPO Lex

Texte(s) princip(al)(aux)

Anglais Therapeutic Goods Act 1989 (No. 21), (consolidated as of December 11, 2012)

Prepared by the Office of Parliamentary Counsel, Canberra

Therapeutic Goods Act 1989

No. 21, 1990 as amended

Compilation start date: 11 December 2012

Includes amendments up to: Act No. 180, 2012

ComLaw Authoritative Act C2013C00132

About this compilation

The compiled Act

This is a compilation of the Therapeutic Goods Act 1989 as amended and in

force on 11 December 2012. It includes any amendment affecting the compiled

Act to that date.

This compilation was prepared on 28 March 2013.

The notes at the end of this compilation (the endnotes) include information

about amending Acts and instruments and the amendment history of each

amended provision.

Uncommenced provisions and amendments

If a provision of the compiled Act is affected by an uncommenced amendment,

the text of the uncommenced amendment is set out in the endnotes.

Application, saving and transitional provisions for amendments

If the operation of an amendment is affected by an application, saving or

transitional provision, the provision is set out in the endnotes.

Modifications

If a provision of the compiled Act is affected by a textual modification that is in

force, the text of the modifying provision is set out in the endnotes.

Provisions ceasing to have effect

If a provision of the compiled Act has expired or otherwise ceased to have

effect in accordance with a provision of the Act, details of the provision are set

out in the endnotes.

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Therapeutic Goods Act 1989 i

Contents

Chapter 1—Preliminary 1 1 Short title ...........................................................................................1

2 Commencement.................................................................................1

3 Interpretation .....................................................................................1

3AA Homoeopathic preparations and homoeopathic standards ...............18

3AB Anthroposophic preparations and anthroposophic standards...........19

3A Declaration—member of European Community .............................20

3B Declaration—country covered by non-EC/EFTA MRA..................20

3C Exempting monographs in pharmacopoeias ....................................21

4 Objects of Act..................................................................................21

5 Act to bind Crown ...........................................................................22

5A Application of the Criminal Code—extended geographical

jurisdiction.......................................................................................22

6 Operation of Act ..............................................................................22

6AAA Commonwealth consent to conferral of functions etc. on its

officers and authorities by corresponding State laws.......................23

6AAB When duty imposed .........................................................................23

6AAC Imposing duty under State law ........................................................25

6AAD Conferral of jurisdiction on federal courts.......................................25

6AAE Consequences of State law conferring duty, function or

power on Commonwealth officer or Commonwealth

authority ..........................................................................................26

6B Review of certain decisions under State laws..................................27

6C Fees payable to Commonwealth under State laws...........................27

7 Declaration that goods are/are not therapeutic goods ......................27

7A Authorised persons ..........................................................................28

7B Kits ..................................................................................................29

7C Secretary may arrange for use of computer programs to

make decisions ................................................................................29

7D Form for product information for medicine.....................................30

8 Power to obtain information with respect to therapeutic

goods ...............................................................................................30

9 Arrangements with States etc. .........................................................31

Chapter 2—Australian Register of Therapeutic Goods 32 9A Australian Register of Therapeutic Goods.......................................32

9B When registrations or listings of medical devices are taken to

be cancelled .....................................................................................33

9C Inspection of entries in Register ......................................................35

9D Variation of entries in Register........................................................35

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9E Publication of list of goods on Register ...........................................38

Chapter 3—Medicines and other therapeutic goods

that are not medical devices 39

Part 3-1—Standards 39 10 Determination of standards..............................................................39

10A Application of standards to medical devices....................................40

13 Special provisions relating to Ministerial standards and

default standards..............................................................................40

13A Special provisions relating to homoeopathic standards and

anthroposophic standards ................................................................42

14 Criminal offences for importing, supplying or exporting

goods that do not comply with standards.........................................42

14A Civil penalties for importing, supplying or exporting goods

that do not comply with standards ...................................................48

14B Application of Customs Act 1901 ....................................................49

15 Criminal offences relating to breaching a condition of a

consent.............................................................................................50

15AA Civil penalty relating to breaching a condition of a consent ............51

15AB Conditions relating to exceptional release of biologicals.................51

Part 3-2—Registration and listing of therapeutic goods 52

Division 1—Preliminary 52

15A Application of this Part to medical devices .....................................52

15B Application of this Part to a biological ............................................54

16 Therapeutic goods and gazetted groups...........................................55

18 Exempt goods ..................................................................................56

18A Exemption because of emergency ...................................................57

19 Exemptions for special and experimental uses ................................60

19A Exemptions where unavailability etc. of therapeutic goods.............62

19B Criminal offences relating to registration or listing etc. of

imported, exported, manufactured and supplied therapeutic

goods ...............................................................................................64

19C Notice required to adduce evidence in support of exception

under subsection 19B(6)..................................................................68

19D Civil penalties relating to registration or listing etc. of

imported, exported, manufactured and supplied therapeutic

goods ...............................................................................................69

20 Criminal offences relating to notifying the Secretary and to

importing goods exempt under section 18A ....................................71

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20A Civil penalty relating to the importation, exportation,

manufacture or supply of sponsored goods without proper

notification ......................................................................................73

21 Offence relating to wholesale supply...............................................74

21A General criminal offences relating to this Part.................................74

21B General civil penalties relating to this Part ......................................79

22 General offences relating to this Part...............................................80

22AA Civil penalty for breaching a condition of an exemption.................83

22A Criminal offences for false statements in applications for

registration.......................................................................................83

22B Civil penalty for false statements in applications for

registration.......................................................................................84

Division 2—Registration and listing 85

23 Applications generally.....................................................................85

24 Applications for registration ............................................................85

24A When evaluation fee due for payment .............................................86

24B Payment of evaluation fee by instalments .......................................86

24C Recovery of evaluation fee ..............................................................87

24D Refund of evaluation fee where evaluation not completed

within prescribed period ..................................................................87

24E Deemed refusal of application .........................................................87

25 Evaluation and registration of therapeutic goods.............................88

25AA Approved product information for medicine ...................................92

25A When the Secretary must not use protected information .................93

25B Registration of therapeutic device to which EC/EFTA

attestation of conformity applies .....................................................94

26 Listing of therapeutic goods ............................................................95

26AA Listing of therapeutic device to which EC/EFTA attestation

of conformity applies.......................................................................98

26A Listing of certain medicines.............................................................99

26B Certificates required in relation to patents .....................................102

26BA Approved form for notices ............................................................104

26BB Permissible ingredients..................................................................104

26BC Variation of determination under section 26BB—Minister’s

initiative.........................................................................................105

26BD Variation of determination under section 26BB—application

by person .......................................................................................105

26C Certificates required in relation to patent infringement

proceedings....................................................................................106

26D Requirements for interlocutory injunction.....................................108

27 Registration or listing number .......................................................110

28 Conditions of registration or listing ...............................................110

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28A Certification of manufacturing steps outside Australia

following application for listing ....................................................114

29 Duration of registration or listing ..................................................114

29A Criminal offence for failing to notify adverse effects etc. of

goods .............................................................................................114

29AA Civil penalty for failing to notify adverse effects etc. of

goods .............................................................................................115

29B Notification of adverse effects etc. where application

withdrawn or lapses.......................................................................116

29C Civil penalties for failing to notify adverse effects etc. where

application withdrawn or lapses ....................................................116

29D Suspension of registration or listing ..............................................117

29E When suspension takes effect etc. .................................................118

29F Revocation of suspension ..............................................................119

29G Effect of suspension ......................................................................120

30 Cancellation of registration or listing ............................................120

30A Revocation of cancellation of registration or listing upon

request ...........................................................................................123

30C Consultation with Gene Technology Regulator.............................123

30D Secretary may seek advice about classes of GM products or

genetically modified organisms .....................................................124

30E Secretary to take advice into account ............................................125

Division 2A—Public notification and recovery of therapeutic

goods 126

30EA Public notification and recovery of therapeutic goods...................126

30EB Publication of requirements...........................................................128

30EC Criminal offences for non-compliance with requirements.............128

30ECA Civil penalty for non-compliance with requirements.....................129

30ED Powers of suspension and cancellation unaffected ........................129

Division 3—General 130

30F Criminal offences for goods exempt under section 18A not

conforming to standards etc...........................................................130

30FA Civil penalty for goods exempt under section 18A not

conforming to standards etc...........................................................132

30G Disposal of unused goods exempt under section 18A ...................132

30H Record for goods exempt under section 18A.................................133

31 Secretary may require information ................................................134

31AAA Civil penalty for providing false or misleading information

in relation to medicines listed under section 26A..........................138

31A Secretary may require information etc. about goods exempt

under section 18.............................................................................139

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31AA Secretary may require information etc. about goods exempt

under section 18A..........................................................................140

31B Secretary may require information relating to approvals and

authorities under section 19...........................................................141

31C Criminal offence for failing to give information or

documents sought under section 31A, 31AA or 31B.....................142

31D False or misleading information ....................................................142

31E False or misleading documents......................................................143

31F Self-incrimination..........................................................................144

Part 3-2A—Biologicals 145

Division 1—Preliminary 145

32 What this Part is about...................................................................145

32A Meaning of biological ...................................................................145

32AA Biological classes ..........................................................................146

32AB When biologicals are separate and distinct from other

biologicals .....................................................................................146

Division 2—Main criminal offences and civil penalties 147

32B What this Division is about ...........................................................147

32BA Criminal offences for importing a biological.................................147

32BB Criminal offences for exporting a biological .................................149

32BC Criminal offences for manufacturing a biological .........................152

32BD Criminal offences for supplying a biological.................................154

32BE Notice required to adduce evidence in support of exception

to offences .....................................................................................156

32BF Civil penalties for importing, exporting, manufacturing or

supplying a biological....................................................................158

32BG Criminal offence and civil penalty relating to a failure to

notify the Secretary about manufacturing......................................161

32BH Criminal offence relating to wholesale supply ..............................163

32BI Criminal offence for using a biological not included in the

32BJ General criminal offences relating to this Part...............................166

32BK Civil penalty for making misrepresentations about

biologicals .....................................................................................167

Division 3—Exemptions 168

Subdivision A—Preliminary 168

32C What this Division is about ...........................................................168

Subdivision B—Exempting biologicals under the regulations 168

32CA Exempt biologicals ........................................................................168

Subdivision C—Exempting biologicals to deal with emergencies 169

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32CB Minister may make exemptions.....................................................169

32CC Conditions of exemptions..............................................................170

32CD Variation or revocation of exemption............................................171

32CE Informing persons of exemption etc. .............................................171

32CF Notification and tabling .................................................................172

32CG Disposal of unused biologicals ......................................................172

32CH Criminal offences for breaching a condition of an exemption .......173

32CI Civil penalty for breaching a condition of an exemption...............174

32CJ Criminal offences and civil penalty for biologicals not

conforming to standards etc...........................................................174

Subdivision D—Exempting biologicals for special and

experimental uses 177

32CK Approvals for importing, exporting or supplying a biological

for special and experimental uses ..................................................177

32CL Conditions of use of biological for experimental purposes in

humans ..........................................................................................178

32CM Exemptions for medical practitioners ............................................179

32CN Criminal offences relating to the giving of an authority to a

medical practitioner .......................................................................180

Subdivision E—Exempting biologicals where substitutes are

unavailable etc. 182

32CO Approvals where substitutes for biologicals are unavailable

etc. .................................................................................................182

Division 4—Including biologicals in the Register 185

Subdivision A—Preliminary 185

32D What this Division is about ...........................................................185

Subdivision B—Class 1 biologicals 185

32DA Application for inclusion in the Register .......................................185

32DB Inclusion of Class 1 biological in the Register ..............................186

32DC Refusal to include Class 1 biological in the Register.....................187

Subdivision C—Biologicals other than Class 1 biologicals 187

32DD Application for inclusion in the Register .......................................187

32DE Evaluation of biologicals ...............................................................188

32DF Inclusion of biological in the Register ...........................................188

32DG Refusal to include biological in the Register .................................189

32DH Lapsing of application ...................................................................190

32DI Evaluation fee................................................................................190

32DJ When evaluation fee due for payment ...........................................191

32DK Payment of evaluation fee by instalments .....................................191

32DL Recovery of evaluation fee ............................................................191

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32DM Reduction of evaluation fee where evaluation not completed

within prescribed period ................................................................191

Subdivision D—Transitional provisions for existing biologicals 192

32DN Transitional provisions for existing biologicals.............................192

Subdivision E—Criminal offences and civil penalties 195

32DO Criminal offences for false statements in applications for

including biologicals in the Register .............................................195

32DP Civil penalty for false statements in applications for

including biologicals in the Register .............................................196

32DQ Criminal offence and civil penalty for failing to notify

adverse effects etc. of biological while it is included in the

32DR Criminal offences and civil penalties for failing to notify

adverse effects etc. of biological where application

withdrawn or lapses.......................................................................197

Subdivision F—Advice from Gene Technology Regulator 199

32DS Consultation with Gene Technology Regulator.............................199

32DT Secretary may seek advice about classes of GM products or

genetically modified organisms .....................................................200

32DU Secretary to take advice into account ............................................200

Division 5—Conditions 202

32E What this Division is about ...........................................................202

32EA Conditions applying automatically ................................................202

32EB Certification of manufacturing steps outside Australia..................204

32EC Imposition of conditions by legislative instrument........................205

32ED Imposition of conditions at time biological included in the

32EE Imposition or variation or removal of conditions after

biological included in the Register ................................................205

32EF Criminal offences for breach of condition .....................................206

32EG Civil penalty for breach of condition.............................................207

Division 6—Suspension from the Register 208

32F What this Division is about ...........................................................208

32FA Suspension of biological from the Register ...................................208

32FB When suspension takes effect etc. .................................................209

32FC Revocation of suspension ..............................................................210

32FD Effect of suspension ......................................................................211

Division 7—Cancellation from the Register 212

32G What this Division is about ...........................................................212

32GA Immediate cancellation of biological from the Register in

various circumstances....................................................................212

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32GB Immediate cancellation of biological from the Register after

failure to comply with information gathering notice .....................213

32GC Cancellation of biological from the Register after notice of

proposed cancellation ....................................................................214

32GD Revocation of cancellation of biological upon request ..................215

32GE Publication of cancellation of entry from Register ........................215

32GF Date of effect of cancellation of entries from Register ..................216

Division 8—Public notification and recovery of biologicals 217

32H What this Division is about ...........................................................217

32HA Public notification and recovery of biologicals .............................217

32HB Publication of requirements...........................................................220

32HC Criminal offences for non-compliance with requirements.............220

32HD Civil penalty for non-compliance with requirements.....................221

32HE Powers of suspension and cancellation unaffected ........................221

Division 9—Obtaining information or documents 222

Subdivision A—Preliminary 222

32J What this Division is about ...........................................................222

Subdivision B—Obtaining information or documents for

biologicals included or proposed to be included in

the Register 222

32JA Secretary may require information or documents ..........................222

32JB Criminal offences for failing to comply with a notice etc..............224

32JC Civil penalty for giving false or misleading information or

document in compliance with a notice ..........................................225

32JD Self-incrimination..........................................................................225

Subdivision C—Obtaining information or documents for

biologicals covered by exemptions 226

32JE Secretary may require information etc. about biologicals

exempt under the regulations.........................................................226

32JF Secretary may require information etc. about biologicals

exempt to deal with emergencies...................................................227

32JG Secretary may require information etc. about biologicals

exempt for special and experimental uses .....................................228

32JH Secretary may require information etc. about biologicals

exempt where substitutes are unavailable etc. ...............................230

32JI Criminal offences for failing to comply with a notice etc..............230

32JJ Civil penalty for giving false or misleading information or

document in compliance with a notice ..........................................231

32JK Self-incrimination..........................................................................231

Subdivision D—Inspecting, copying and retaining documents 232

32JL Secretary may inspect and copy documents ..................................232

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32JM Secretary may retain documents ....................................................232

Part 3-3—Manufacturing of therapeutic goods 233 33A Application of this Part to medical devices ...................................233

33B Application of this Part to biologicals ...........................................233

34 Exempt goods and exempt persons................................................233

35 Criminal offences relating to manufacturing therapeutic

goods .............................................................................................233

35A Civil penalties relating to manufacturing therapeutic goods..........237

35B Criminal offences relating to breaching a condition of a

licence............................................................................................237

35C Civil penalty relating to breaching a condition of a licence...........238

36 Manufacturing principles...............................................................239

37 Application for licence ..................................................................239

38 Grant of licence .............................................................................241

38A Guidelines for multi-site licences ..................................................243

38B Splitting multi-site licences ...........................................................244

39 Term of licence..............................................................................246

40 Conditions of licences ...................................................................246

40A Variation of manufacturing site authorisations—Secretary’s

own initiative.................................................................................249

40B Variation of licences—application by licence holder ....................249

41 Revocation and suspension of licences..........................................251

41AA Spent convictions scheme..............................................................254

41AAA Transfer of licences .......................................................................254

41A Publication of list of manufacturers etc. ........................................254

Chapter 4—Medical devices 256

Part 4-1—Introduction 256

Division 1—Overview of this Chapter 256

41B General ..........................................................................................256

41BA Requirements for medical devices (Parts 4-2 and 4-3) ..................256

41BB Administrative processes (Parts 4-4 to 4-10).................................256

41BC Enforcement (Part 4-11) ................................................................257

Division 2—Interpretation 258

41BD What is a medical device ...............................................................258

41BE Kinds of medical devices...............................................................259

41BEA Excluded purposes.........................................................................260

41BF System or procedure packs ............................................................260

41BG Manufacturers of medical devices .................................................260

41BH Meaning of compliance with essential principles ..........................261

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41BI Meaning of non-application of conformity assessment

procedures .....................................................................................262

Division 3—Application provisions 263

41BJ Application of this Chapter to medical devices covered by

Part 3-2 ..........................................................................................263

41BJA Application of this Chapter to a biological ....................................263

41BK Application of the Criminal Code .................................................265

Part 4-2—Essential principles and medical device standards 266 41C What this Part is about...................................................................266

Division 1—Essential principles 267

41CA Essential principles........................................................................267

Division 2—Medical device standards 268

41CB Medical device standards...............................................................268

41CC Content of medical device standards .............................................268

41CD Inconsistencies between medical device standards........................269

Part 4-3—Conformity assessment procedures 270 41D What this Part is about...................................................................270

Division 1—Conformity assessment procedures 271

41DA Conformity assessment procedures ...............................................271

41DB Medical device classifications .......................................................272

Division 2—Conformity assessment standards 273

41DC Conformity assessment standards..................................................273

41DD Content of conformity assessment standards .................................273

41DE Inconsistencies between conformity assessment standards ...........274

Part 4-4—Conformity assessment certificates 275 41E What this Part is about...................................................................275

Division 1—Issuing conformity assessment certificates 276

41EA When conformity assessment certificates are required ..................276

41EB Applications...................................................................................276

41EC Considering applications ...............................................................277

41ED Time for making decisions on applications ...................................278

41EE Procedure following making a decision whether to issue

certificate .......................................................................................279

41EF Duration of certificate....................................................................279

41EG Lapsing of applications..................................................................279

41EH Treating applications as having been refused ................................280

41EI Criminal offences for making a false statement.............................281

41EIA Civil penalty for making a false statement ....................................282

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Division 2—Conditions 283

41EJ Automatic conditions on conformity assessment certificates ........283

41EK Conditions imposed when conformity assessment certificates

are issued .......................................................................................285

41EL Conditions imposed after issuing a conformity assessment

certificate .......................................................................................285

Division 3—Suspension of conformity assessment certificates 286

41EM Suspension of conformity assessment certificates .........................286

41EN Notice of proposed suspension ......................................................286

41EO Duration of suspension ..................................................................286

41EP Revocation of suspension ..............................................................287

41EQ Powers of revocation of conformity assessment certificates

unaffected ......................................................................................288

Division 4—Revocation of conformity assessment certificates 289

41ER Automatic revocation of conformity assessment certificates.........289

41ES Immediate revocation of conformity assessment certificates.........289

41ET Revocation of conformity assessment certificates after notice

of proposed revocation ..................................................................289

41EU Limiting revocation of conformity assessment certificates to

some medical devices of a particular kind .....................................291

41EV Publication of revocation etc. of conformity assessment

certificates .....................................................................................292

41EW Date of effect of revocation etc. of conformity assessment

certificates .....................................................................................292

Part 4-5—Including medical devices in the Register 293 41F What this Part is about...................................................................293

Division 1—Including medical devices in the Register 294

41FA What this Division is about ...........................................................294

41FB How this Division works ...............................................................295

Subdivision A—Applications 295

41FC Applications...................................................................................295

41FD Matters to be certified....................................................................296

41FE Criminal offences for making a false statement.............................297

41FEA Civil penalty for making a false statement ....................................299

Subdivision B—Including kinds of medical devices in the Register 299

41FF Obligation to include kinds of medical devices in the

41FG Notification of unsuccessful applications ......................................300

Subdivision C—Auditing of applications 300

41FH Selecting applications for auditing ................................................300

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41FI Auditing of applications ................................................................300

41FJ Procedure following audits ............................................................301

41FK Lapsing of applications..................................................................301

Subdivision D—Miscellaneous 302

41FL Device number ..............................................................................302

41FM Duration of inclusion in the Register .............................................302

Division 2—Conditions 303

41FN Conditions applying automatically ................................................303

41FO Conditions imposed when kinds of medical devices are

included in the Register .................................................................305

41FP Conditions imposed after kinds of medical devices are

included in the Register .................................................................306

Part 4-6—Suspension and cancellation from the Register 307

Division 1—Suspension from the Register 307

Subdivision A—General power of suspension 307

41G What this Part is about...................................................................307

41GA Suspension of kinds of medical devices from the Register............307

41GB Notice of proposed suspension must be given in certain cases ......308

41GC Duration of suspension ..................................................................308

41GD Revocation of suspension ..............................................................309

41GE Treating applications for revocation as having been refused .........310

Subdivision B—Suspension as a result of suspension under

Part 4-4 310

41GF Suspension of kinds of medical devices from the Register............310

41GG Duration of suspension ..................................................................311

41GH Revocation of suspension ..............................................................311

Subdivision C—Effect of suspension 311

41GI Effect of suspension ......................................................................311

41GJ Powers of cancellation from Register unaffected ..........................312

Division 2—Cancellation of entries from the Register 313

41GK Automatic cancellation of entries of kinds of medical devices

from the Register ...........................................................................313

41GL Immediate cancellation of entries of kinds of medical

devices from the Register ..............................................................313

41GM Cancellation of entries of kinds of medical devices from the

41GN Cancellation of entries of kinds of medical devices from the

41GO Limiting cancellation of entries from Register to some

medical devices of a particular kind ..............................................316

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41GP Publication of cancellation of entry from Register ........................316

41GQ Date of effect of cancellation of entries from Register ..................317

Part 4-6A—Exempting medical devices to deal with

emergencies 318 41GR What this Part is about...................................................................318

41GS Minister may make exemptions.....................................................318

41GT Conditions of exemptions..............................................................319

41GU Variation or revocation of exemption............................................320

41GV Informing persons of exemption etc. .............................................321

41GW Notification and tabling .................................................................321

41GY Disposal of unused medical devices ..............................................322

Part 4-7—Other exemptions from including medical devices in

the Register 323 41H What this Part is about...................................................................323

41HA Devices exempted from inclusion in the Register..........................323

41HB Exemptions for special and experimental uses ..............................324

41HC Exemptions for medical practitioners ............................................325

41HD Approvals if substitutes for medical devices are unavailable

or in short supply...........................................................................326

Part 4-8—Obtaining information 330 41J What this Part is about...................................................................330

Division 1—Information relating to compliance with

requirements and other matters 331

41JA Secretary may require information ................................................331

41JB Complying with the Secretary’s requirements ...............................333

41JBA Civil penalty for giving false or misleading information in

purported compliance with a notice...............................................335

41JC Self-incrimination..........................................................................335

Division 2—Information relating to medical devices covered by

exemptions 336

41JCA Secretary may require information etc. about medical

devices exempt under Part 4-6A....................................................336

41JD Secretary may require information etc. about devices

exempted under section 41HA from inclusion in the Register ......336

41JE Secretary may require information relating to approvals

under section 41HB .......................................................................337

41JF Secretary may require information relating to authorities

under section 41HC .......................................................................339

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41JFA Secretary may require information relating to approvals

under section 41HD.......................................................................339

41JG Criminal offences for failing to give information or

documents sought under this Division...........................................340

41JH False or misleading information ....................................................340

41JI False or misleading documents......................................................341

41JJ Self-incrimination..........................................................................341

Part 4-9—Public notification and recovery of medical devices 343 41K What this Part is about...................................................................343

41KA Public notification and recovery of medical devices .....................343

41KB Publication of requirements...........................................................345

41KC Criminal offences for failing to comply with requirements

relating to a kind of medical device...............................................346

41KCA Civil penalty for failing to comply with requirements relating

to a kind of medical device............................................................347

41KD Powers of suspension and cancellation unaffected ........................347

Part 4-10—Assessment fees 348 41L What this Part is about...................................................................348

41LA Assessment fees.............................................................................348

41LB When assessment fee due for payment ..........................................349

41LC Payment of assessment fee by instalments ....................................349

41LD Recovery of assessment fee ...........................................................349

41LE Reduction of conformity assessment fee where decision not

made within prescribed period.......................................................349

Part 4-11—Offences and civil penalty provisions relating to

medical devices 351 41M What this Part is about...................................................................351

Division 1—Non-compliance with essential principles 352

41MA Criminal offences for importing, supplying or exporting a

medical device that does not comply with essential principles......352

41MAA Civil penalties for importing, supplying or exporting a

medical device that does not comply with essential principles......356

41MB Exceptions .....................................................................................357

41MC Criminal offences relating to breaching a condition of a

consent...........................................................................................358

41MCA Civil penalty relating to breaching a condition of a consent ..........359

41MD Treating medical devices as prohibited imports or exports............359

Division 2—Failure to apply conformity assessment procedures 360

41ME Criminal offences for failing to apply conformity assessment

procedures—manufacturers ...........................................................360

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41MEA Civil penalties for failing to apply conformity assessment

procedures—manufacturers ...........................................................363

41MF Criminal offences for failing to apply conformity assessment

procedures—sponsors....................................................................363

41MG Exceptions .....................................................................................365

41MH Criminal offence for making false statements in declarations .......366

41MHA Civil penalty for making false statements in declarations..............366

Division 3—Medical devices not included in the Register and

related matters 367

41MI Criminal offences for importing, exporting, supplying or

manufacturing a medical device not included in the Register........367

41MIA Notice required to adduce evidence in support of exception

under subsection 41MI(7)..............................................................370

41MIB Civil penalty for importing, exporting, supplying or

manufacturing a medical device not included in the Register........371

41MJ Treating medical devices as prohibited imports or exports............372

41MK Wholesale supply of medical devices not included in the

41ML False advertising about medical devices........................................373

41MLA Civil penalty for making misrepresentations about medical

devices...........................................................................................373

41MM Claims about arranging supplies of medical devices not

included in the Register .................................................................374

41MN Criminal offences relating to breaches of conditions.....................374

41MNA Civil penalties for breaching conditions ........................................377

Division 3A—Offences and civil penalties related to exemptions

under Part 4-6A 378

41MNB Criminal offences for breaching a condition of an exemption .......378

41MNC Civil penalty for breaching a condition of an exemption...............379

41MND Civil penalty for making misrepresentations about medical

devices...........................................................................................379

Division 4—Other offences and civil penalty provisions 380

41MO Criminal offences for misusing medical devices exempted

for special or experimental uses ....................................................380

41MP Criminal offence for failing to notify adverse events etc. ..............382

41MPA Civil penalty for failing to notify adverse events etc. ....................384

41MPB Relief from liability for contraventions for failing to notify

adverse events etc. .........................................................................385

41MQ Notification of adverse events etc. where application

withdrawn or lapses.......................................................................386

41MR Civil penalties for failing to notify adverse effects etc. where

application withdrawn or lapses ....................................................386

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Chapter 5—Advertising, counterfeit therapeutic goods

and product tampering 388

Part 5-1—Advertising and generic information 388

Division 1—Preliminary 388

42AA This Part not to apply to advertisements directed at health

professionals etc. ...........................................................................388

42AB This Part not to apply to advertisements for goods not for

human use......................................................................................389

42AC This Part not to apply to advertisements for exported goods .........389

42B Definitions.....................................................................................389

42BAA Therapeutic Goods Advertising Code............................................391

Division 2—Therapeutic goods advertisements for which an

approval is required 392

42BA Application of Division .................................................................392

42C Offences relating to publication of advertisements........................392

Division 3—General provisions about advertising therapeutic

goods 395

42DA Simplified outline ..........................................................................395

42DB Definitions.....................................................................................395

42DD Restricted representations..............................................................395

42DE Applications for approval of use of restricted representation ........396

42DF Approval of use of restricted representation ..................................396

42DG Notice of approval or refusal .........................................................396

42DH Variation of conditions of approval ...............................................397

42DI Withdrawal of approval .................................................................397

42DJ Prohibited and required representations.........................................398

42DK Use of restricted or prohibited representations ..............................398

Division 3A—Therapeutic goods advertisements for which an

approval is not required 399

42DKA Application of Division .................................................................399

42DKB Certain representations not to be published or broadcast...............399

42DL Advertising offences......................................................................399

42DM Compliance with Code ..................................................................401

Division 4—Generic information about ingredients or

components of therapeutic goods 402

42DN Application of Division .................................................................402

42DO Compliance with the Code ............................................................402

42DP Offences—publication of generic information ..............................402

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Part 5-2—Counterfeit therapeutic goods 403 42E Offence of dealing with counterfeit therapeutic goods ..................403

42EA Civil penalty relating to dealing with counterfeit therapeutic

goods .............................................................................................404

42EB Relief from liability for certain contraventions relating to

dealing with counterfeit therapeutic goods ....................................404

42F Customs treatment of counterfeit therapeutic goods......................405

Part 5-3—Product tampering 406 42T Notifying of actual or potential tampering.....................................406

42U Meaning of actual or potential tampering etc. ..............................407

42V Recovery of therapeutic goods because of actual or potential

tampering.......................................................................................408

42VA Civil penalty relating to the recovery of therapeutic goods

because of actual or potential tampering .......................................410

42VB Relief from liability for contraventions relating to the

recovery of therapeutic goods because of actual or potential

tampering.......................................................................................410

42W Supply etc. of therapeutic goods that are subject to recovery

requirements ..................................................................................411

42X Saving of other laws ......................................................................412

Chapter 5A—Enforcement 413

Part 5A-1—Civil penalties 413

Division 1—Obtaining an order for a civil penalty 413

42Y Federal Court may order person to pay pecuniary penalty for

contravening civil penalty provision..............................................413

42YA What is a civil penalty provision?..................................................414

42YB Meaning of penalty unit.................................................................414

42YC Persons involved in contravening civil penalty provision .............414

42YD Recovery of a pecuniary penalty ...................................................414

42YE Gathering information for application for pecuniary penalty ........415

Division 2—Civil penalty proceedings and criminal proceedings 416

42YF Civil proceedings after criminal proceedings ................................416

42YG Criminal proceedings during civil proceedings .............................416

42YH Criminal proceedings after civil proceedings ................................416

42YI Evidence given in proceedings for civil penalty not

admissible in criminal proceedings................................................416

Part 5A-2—Infringement notices 418 42YJ Infringement notices in respect of offences ...................................418

42YK Infringement notices in respect of civil penalty provisions ...........418

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xviii Therapeutic Goods Act 1989

Part 5A-3—Enforceable undertakings 419 42YL Enforcement of undertakings.........................................................419

Chapter 6—Administration 420

Part 6-1—Payment of charges 420 43 By whom charges payable .............................................................420

44 Time for payment of charges .........................................................420

44A Exemptions from liability to pay charges ......................................421

44B Recovery of unpaid charges...........................................................422

45 Therapeutic Goods Administration Account .................................423

Part 6-2—Entry, searches and warrants 424 45A Definitions.....................................................................................424

46 Searches to monitor compliance with Act .....................................425

46A Searches of certain premises to monitor compliance with Act ......425

46B Searches and seizures on public health grounds ............................427

47 Searches and seizures related to offences and civil penalty

provisions ......................................................................................427

48 General powers of authorised persons in relation to premises .......428

48A Details of warrant to be given to occupier etc. ..............................429

48B Announcement before entry ..........................................................430

48C Use of electronic equipment at premises .......................................430

48D Compensation for damage to electronic equipment.......................432

48E Copies of seized things to be provided ..........................................432

48F Occupier entitled to be present during search ................................433

48G Receipts for things seized under warrant .......................................433

48H Retention of seized things..............................................................433

48J Magistrate may permit a thing to be retained ................................434

49 Monitoring warrants ......................................................................434

50 Offence and civil penalty provision related warrants ....................435

51 Offence and civil penalty provision related warrants by

telephone .......................................................................................436

51A Searches at request of manufacturer ..............................................438

51B Offences relating to warrants.........................................................438

52 Identity cards .................................................................................439

Part 6-3—Scheduling of substances 440 52AA Overview .......................................................................................440

52A Definitions.....................................................................................440

52B Advisory Committee on Medicines Scheduling ............................441

52C Advisory Committee on Chemicals Scheduling ............................442

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52CA Joint meetings................................................................................442

52D Poisons Standard ...........................................................................443

52E Secretary to take certain matters into account in exercising

powers ...........................................................................................443

52EAA Application for amendment of the Poisons Standard.....................444

52EA Poisons Standard—validation etc. .................................................445

52EB Compensation for acquisition of property .....................................446

52EC Review of scheduling regime ........................................................447

Chapter 7—Miscellaneous 449 53 Retention of material on withdrawal of application.......................449

53A Alternative verdicts for various offences .......................................449

54 Offences and forfeiture ..................................................................451

54AA Offences for contravening conditions or requirements

imposed under the regulations .......................................................451

54AB Criminal offence for damaging etc. documents .............................452

54AC Civil penalty for damaging etc. documents ...................................452

54A Time for bringing prosecutions .....................................................453

54B Personal liability of an executive officer of a body

corporate—general ........................................................................453

54BA Personal liability of an executive officer of a body

corporate—offences covered .........................................................454

54C Establishing whether an executive officer took reasonable

steps to prevent the commission of an offence or the

contravention of a civil penalty provision .....................................456

55 Conduct by directors, servants and agents .....................................457

56 Judicial notice................................................................................458

56A Certificates to provide evidence of certain matters ........................458

57 Delegation .....................................................................................461

58 Export certifications ......................................................................463

59 Fees ...............................................................................................463

60 Review of decisions.......................................................................463

60A New information on review—discretion to remit ..........................466

61 Release of information...................................................................469

61A Immunity from civil actions ..........................................................475

63 Regulations....................................................................................476

Chapter 8—Repeal and transitional provisions 479 66 Transitional arrangements for goods required to be registered

or listed..........................................................................................479

67 Transitional provision for therapeutic goods for export only.........481

68 Transitional arrangements for Part 3-3 ..........................................481

69 Continuation of standards and requirements..................................482

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Endnotes 483

Endnote 1—Legislation history 483

Endnote 2—Amendment history 494

Endnote 3—Application, saving and transitional provisions 528

Therapeutic Goods Amendment Act (No. 2) 2000 (No. 56, 2000) 528

Therapeutic Goods Amendment Act (No. 3) 2000 (No. 120, 2000) 528

Therapeutic Goods Amendment Act 2001 (No. 14, 2001) 529

Australia New Zealand Food Authority Amendment Act 2001

(No. 81, 2001) 530

Health and Aged Care Legislation Amendment (Application of

Criminal Code) Act 2001 (No. 111, 2001) 530

Therapeutic Goods Amendment (Medical Devices) Act 2002 (No. 24,

2002) 530

Therapeutic Goods and Other Legislation Amendment Act 2002

(No. 56, 2002) 532

Therapeutic Goods Amendment Act (No. 1) 2003 (No. 39, 2003) 532

US Free Trade Agreement Implementation Act 2004 (No. 120, 2004) 533

Financial Framework Legislation Amendment Act 2005 (No. 8, 2005) 534

Therapeutic Goods Amendment Act (No. 2) 2006 (No. 2, 2006) 534

Therapeutic Goods Amendment (Repeal of Ministerial responsibility

for approval of RU486) Act 2006 (No. 5, 2006) 535

Therapeutic Goods Legislation Amendment (Annual Charges) Act

2008 (No. 96, 2008) 535

Therapeutic Goods Amendment (Medical Devices and Other

Measures) Act 2009 (No. 38, 2009) 535

Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009

(No. 76, 2009) 538

Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009

(No. 96, 2009) 544

Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010

(No. 54, 2010) 545

Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010

(No. 141, 2010) 548

Acts Interpretation Amendment Act 2011 (No. 46, 2011) 550

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Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011

(No. 77, 2011) 550

Endnote 4—Uncommenced amendments 552

Endnote 5—Misdescribed amendments 553

ComLaw Authoritative Act C2013C00132

Preliminary Chapter 1

Section 1

Therapeutic Goods Act 1989 1

An Act relating to therapeutic goods

Chapter 1—Preliminary

1 Short title

This Act may be cited as the Therapeutic Goods Act 1989.

2 Commencement

This Act commences on the day after the day on which a House of

the Parliament approves regulations made under this Act in the

same form as approved by the other House, provided that:

(a) not more than 90 days have elapsed; and

(b) the places of Senators have not become vacant under section 13

of the Constitution; and

has not occurred;

between the approval of one House and the approval of the other

House.

3 Interpretation

(1) In this Act, unless the contrary intention appears:

accessory, in relation to a medical device covered by

paragraph 41BD(1)(a), (aa) or (ab), means a thing that the

manufacturer of the thing specifically intended to be used together

with the device to enable the device to be used as the manufacturer

of the device intended.

actual or potential tampering has the meaning given by

section 42U.

advertisement, in relation to therapeutic goods, includes any

statement, pictorial representation or design, however made, that is

intended, whether directly or indirectly, to promote the use or

supply of the goods.

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anthroposophic pharmacopoeia means:

(a) a publication specified under paragraph 3AB(3)(a), as that

publication is in force from time to time; or

(b) a part of a publication specified under paragraph 3AB(3)(b),

as that part is in force from time to time.

anthroposophic preparation has the meaning given by

subsection 3AB(1).

anthroposophic standard has the meaning given by

subsection 3AB(2).

application audit assessment fee means a fee payable under

subsection 41LA(3).

assessment fee means:

(a) a conformity assessment fee; or

(b) an application audit assessment fee;

payable under Part 4-10.

authorised person means:

(a) in relation to any provision of this Act, a person authorised

by the Secretary to exercise powers under that provision; or

(b) in relation to a provision of Part 6-2, a member of the

Australian Federal Police, or a Customs officer exercising

powers in a Customs place (within the meaning of

section 183UA of the Customs Act 1901).

batch means a quantity of a product that is:

(a) uniform in composition, method of manufacture and

probability of chemical or microbial contamination; and

(b) made in one cycle of manufacture and, in the case of a

product that is sterilised or freeze dried, sterilised or freeze

dried in one cycle.

bioburden, in relation to therapeutic goods, means the quantity and

characteristics of microorganisms present in the goods or to which

the goods may be exposed in a manufacturing environment.

biological has the meaning given by section 32A.

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Therapeutic Goods Act 1989 3

biological number of a biological means:

(a) the number assigned to the biological under

subsection 32DB(2), 32DF(2) or 32DN(5); or

(b) if, in accordance with regulations made for the purposes of

paragraph 9A(4)(ca), a different number is assigned to the

biological—that different number.

British Pharmacopoeia means the edition of the publication of that

name, including any additions or amendments, that was in effect

for the purposes of this Act immediately before the commencement

of Schedule 4 to the Therapeutic Goods Amendment (Medical

Devices and Other Measures) Act 2009 and, if additions or

amendments of that publication are made after that

commencement, or new editions of that publication are published

after that commencement, includes those additions or amendments,

or those new editions, from the effective date published by the

British Pharmacopoeia Commission or any replacement body.

civil penalty provision has the meaning given by section 42YA.

Class 1 biological means a biological included in a class of

biologicals that is:

(a) a class prescribed by the regulations for the purposes of

section 32AA; and

(b) a class referred to in those regulations as Class 1 biologicals.

Commonwealth authority includes:

(a) a body corporate, or an unincorporated body, established for

a public purpose by or under an Act; and

(b) a tribunal or authority established by or in accordance with

an Act.

Commonwealth officer includes:

(a) a Minister; and

(b) a person holding:

(i) an office established by or under an Act; or

(ii) an appointment made under an Act; or

(iii) an appointment made by the Governor-General or a

Minister but not under an Act; and

authority; and

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4 Therapeutic Goods Act 1989

(d) a person who is in the service or employment of the

Commonwealth, or of a Commonwealth authority, or is

employed or engaged under an Act or regulations made

under an Act.

composite pack has the meaning given by subsection 7B(2).

conformity assessment certificate means a certificate issued under

section 41EE.

conformity assessment fee means a fee payable under

subsection 41LA(1).

conformity assessment procedures has the meaning given by

section 41DA.

conformity assessment standard means a conformity assessment

standard specified in an order under section 41DC.

container, in relation to therapeutic goods, means the vessel,

bottle, tube, ampoule, syringe, vial, sachet, strip pack, blister pack,

wrapper, cover or other similar article that immediately covers the

goods, but does not include an article intended for ingestion.

corporation means a body corporate that is:

(a) a foreign corporation; or

(b) a trading corporation formed within the limits of the

Commonwealth or a financial corporation so formed.

corresponding State law means a State law declared by the

regulations to correspond to this Act or the regulations, including

such a law as amended from time to time.

counterfeit has the meaning given by section 42E.

current Poisons Standard has the meaning given by section 52A.

Customs officer means an officer of Customs within the meaning

of the Customs Act 1901.

data processing device means any article or material (for example,

a disc) from which information is capable of being reproduced with

or without the aid of any other article or device.

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Therapeutic Goods Act 1989 5

default standard means any of the following:

(a) a standard referred to in paragraph (b) of the definition of

standard in this subsection;

(b) a standard referred to in paragraph (c) of that definition;

device number, in relation to a medical device, means any

combination of numbers, symbols and letters assigned to the device

under section 41FL.

directions for use, in relation to therapeutic goods, includes

information on:

(a) appropriate doses of the goods; and

(b) the method of administration or use of the goods; and

the goods; and

(d) the use of the goods by persons of particular ages or by

persons having particular medical conditions.

EC/EFTA attestation of conformity means an attestation of

conformity (within the meaning of the EC Mutual Recognition

Agreement or the EFTA Mutual Recognition Agreement) issued by

an EC/EFTA conformity assessment body that is approved by the

Secretary in writing.

EC/EFTA conformity assessment body means a Conformity

Assessment Body designated in one of the following Sectoral

Annexes to the EC Mutual Recognition Agreement or the EFTA

Mutual Recognition Agreement:

(a) Sectoral Annex (Medical Devices);

(b) Sectoral Annex (Medicinal Products GMP Inspection and

Batch Certification).

EC Mutual Recognition Agreement means the Agreement on

Mutual Recognition in relation to Conformity Assessment,

Certificates and Markings between Australia and the European

Community, as in force from time to time.

EFTA Mutual Recognition Agreement means the Agreement on

Mutual Recognition in relation to Conformity Assessment,

Certificates and Markings between Australia and the European

Free Trade Association, as in force from time to time.

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6 Therapeutic Goods Act 1989

essential principles has the meaning given by section 41CA.

ethics committee means a committee:

(a) constituted and operating as an ethics committee in

accordance with guidelines issued by the CEO of the

National Health and Medical Research Council as in force

from time to time; and

(b) which has notified its existence to the Australian Health

Ethics Committee established under the National Health and

Medical Research Council Act 1992.

European Pharmacopoeia means the English edition of the

publication of that name, including any additions or amendments,

that was in effect immediately before the commencement of this

definition and, if additions or amendments of that publication are

made after that commencement, or new editions of that publication

are published after that commencement, includes those additions or

amendments, or those new editions, from the effective date

published by the Council of Europe or any replacement body.

exempt device means a medical device that is of a kind that is

exempted from Division 3 of Part 4-11 by the regulations.

exempt goods, in relation to a provision of Part 3-2, means

therapeutic goods that are exempted from the operation of that Part

(except section 31A and sections 31C to 31F) by the regulations.

exempt goods, in relation to a provision of Part 3-3, means

therapeutic goods that are exempted from the operation of that Part

by the regulations.

exempt person, in relation to therapeutic goods, means a person

exempted from the operation of Part 3-3 in relation to those goods

by the regulations.

export only medicine means a medicine that:

(a) is manufactured in Australia for export only, or imported into

Australia for export only; and

(b) is listable goods only because it is so manufactured or

imported (and not for any other reason).

Federal Court means the Federal Court of Australia.

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Therapeutic Goods Act 1989 7

financial corporation means a financial corporation within the

meaning of paragraph 51(xx) of the Constitution.

first Poisons Standard has the meaning given by section 52A.

foreign corporation means a foreign corporation within the

meaning of paragraph 51(xx) of the Constitution.

gazetted kits group means a group of kits identified in an order in

force under subsection 16(3A).

gazetted therapeutic devices group has the meaning given by

subsection 16(3).

gazetted therapeutic goods group has the meaning given by

subsection 16(2).

Gene Technology Regulator has the same meaning as in the Gene

Technology Act 2000.

genetically modified organism has the same meaning as in the

Gene Technology Act 2000.

GM product has the same meaning as in the Gene Technology Act

2000.

grouped therapeutic goods means therapeutic goods included in:

(a) a gazetted therapeutic goods group; or

(b) a gazetted therapeutic devices group; or

homoeopathic pharmacopoeia means:

(a) a publication specified under paragraph 3AA(3)(a), as that

publication is in force from time to time; or

(b) a part of a publication specified under paragraph 3AA(3)(b),

as that part is in force from time to time.

homoeopathic preparation has the meaning given by

subsection 3AA(1).

homoeopathic standard has the meaning given by

subsection 3AA(2).

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8 Therapeutic Goods Act 1989

included in the Register:

(a) in relation to a biological—means included in the Register

under Part 3-2A; and

(b) in relation to a medical device to which Chapter 4 applies—

means included in the Register under Chapter 4.

Note: Section 41BJ deals with the application of Chapter 4 to medical devices.

indications, in relation to therapeutic goods, means the specific

therapeutic uses of the goods.

international instrument means:

(a) any treaty, convention, protocol, agreement or other

instrument that is binding in international law; and

(b) a part of such a treaty, convention, protocol, agreement or

other instrument.

kind, in relation to a medical device, has the meaning given by

section 41BE.

label, in relation to therapeutic goods, means a display of printed

information:

(a) on or attached to the goods; or

(b) on or attached to a container or primary pack in which the

goods are supplied; or

licence means a licence under Part 3-3.

listable devices means therapeutic devices that are required to be

included in the part of the Register for listed goods.

listable goods means therapeutic goods that are required:

(a) under the regulations; or

(b) by a notice published in the Gazette under subsection 9A(5);

to be included in the part of the Register relating to listed goods.

listed goods means therapeutic goods that are included in the Part

of the Register for goods known as listed goods.

listing number, in relation to listed goods, means any combination

of numbers, symbols and letters assigned to the goods under

section 27.

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Therapeutic Goods Act 1989 9

major interest holder of a body corporate means a person who:

(a) is in a position to cast, or control the casting of, more than

one-fifth of the maximum number of votes that might be cast

at a general meeting of the body corporate; or

(b) holds more than one-fifth of the issued share capital of the

body corporate (excluding any part of that issued share

capital that carries no right to participate beyond a specified

amount in a distribution of either profits or capital).

manufacture, in relation to therapeutic goods that are not medical

devices, means:

(a) to produce the goods; or

(b) to engage in any part of the process of producing the goods

or of bringing the goods to their final state, including

engaging in the processing, assembling, packaging, labelling,

storage, sterilising, testing or releasing for supply of the

goods or of any component or ingredient of the goods as part

of that process.

manufacturer, of a medical device, has the meaning given by

section 41BG.

manufacturing principles means the principles for the time being

having effect under section 36.

manufacturing site means premises:

(a) that are for use in the manufacture of a particular kind of

therapeutic goods; and

(b) at which the same persons have control of the management of

the production of the goods and the procedures for quality

control.

manufacturing site authorisation means an authorisation referred

to in subsection 38(2B) or 40B(4).

medical device has the meaning given by section 41BD.

medical device classification means a classification specified in

the regulations made for the purposes of section 41DB.

medical device standard, in relation to a kind of medical device,

means a medical device standard, specified in an order under

section 41CB, that is applicable to that kind of medical device.

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10 Therapeutic Goods Act 1989

medicine means:

(a) therapeutic goods (other than biologicals) that are

represented to achieve, or are likely to achieve, their

principal intended action by pharmacological, chemical,

immunological or metabolic means in or on the body of a

human; and

(b) any other therapeutic goods declared by the Secretary, for the

purpose of the definition of therapeutic device, not to be

therapeutic devices.

member of EFTA means a country declared by the Minister under

section 3A to be a member of the European Free Trade

Association.

member of the European Community means a country declared

by the Minister under section 3A to be a member of the European

Community.

mother substance means any of the following:

(a) an animal;

(b) a plant;

(d) a fungus;

(e) a micro-organism;

(f) a mineral;

(g) a mineral compound;

(h) a chemical;

(i) a product obtained from any of the things mentioned in

paragraphs (a) to (h).

Mutual Recognition Convention means the Convention for the

Mutual Recognition of Inspections in respect of the Manufacture of

Pharmaceutical Products done at Geneva on 8 October 1970.

National Manager of the Therapeutic Goods Administration

means:

(a) the person holding the position of National Manager of the

Therapeutic Goods Administration; or

(b) if the position of National Manager of the Therapeutic Goods

Administration ceases to exist, or ceases to be referred to by

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Section 3

Therapeutic Goods Act 1989 11

that name—the person holding a position determined in

writing by the Secretary.

non-EC/EFTA attestation of conformity, for a non-EC/EFTA

MRA, means an attestation of conformity issued, after the

non-EC/EFTA MRA has come into force, by a conformity

assessment body that is designated in the non-EC/EFTA MRA and

approved by the Secretary in writing for the non-EC/EFTA MRA.

non-EC/EFTA MRA means an international instrument that

Australia is bound by, or is a party to, if:

(a) a purpose of the instrument is the recognition of attestations

of conformity; and

(b) the instrument satisfies the requirements (if any) set out in

regulations made for the purposes of this paragraph;

but does not include:

(d) the EFTA Mutual Recognition Agreement.

oath includes affirmation.

penalty unit, in relation to a civil penalty provision, has the

meaning given by section 42YB.

poison means an ingredient, compound, material or preparation

which, or the use of which, may cause death, illness or injury and

includes any ingredient, compound, material or preparation

referred to in a schedule to the current Poisons Standard.

premises includes:

(a) a structure, building, aircraft, vehicle or vessel; and

(b) a place (whether enclosed or built upon or not); and

presentation, in relation to therapeutic goods, means the way in

which the goods are presented for supply, and includes matters

relating to the name of the goods, the labelling and packaging of

the goods and any advertising or other informational material

associated with the goods.

primary pack, in relation to therapeutic goods, means the complete

pack in which the goods, or the goods and their container, are to be

supplied to consumers.

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12 Therapeutic Goods Act 1989

product information, in relation to therapeutic goods, means

information relating to the safe and effective use of the goods,

including information regarding the usefulness and limitations of

the goods.

protected information, in relation to therapeutic goods, has the

meaning given by section 25A.

quality, in relation to therapeutic goods, includes the composition,

strength, potency, stability, sterility, purity, bioburden, design,

construction and performance characteristics of the goods.

refurbishment has the meaning given by the regulations.

Register means the Australian Register of Therapeutic Goods

maintained under section 9A.

registered goods means therapeutic goods included in the part of

the Register for goods known as registered goods.

registration number, in relation to registered goods, means any

combination of numbers, symbols and letters assigned to the goods

under section 27.

restricted medicine means:

(a) a medicine specified in an instrument under subsection (2A);

(b) a medicine included in a class of medicine specified in an

instrument under subsection (2B).

scheduling has the meaning given by section 52A.

Secretary means the Secretary of the Department.

sponsor, in relation to therapeutic goods, means:

(a) a person who exports, or arranges the exportation of, the

goods from Australia; or

(b) a person who imports, or arranges the importation of, the

goods into Australia; or

arranges for another person to manufacture the goods, for

supply (whether in Australia or elsewhere);

but does not include a person who:

(d) exports, imports or manufactures the goods; or

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(e) arranges the exportation, importation or manufacture of the

goods;

on behalf of another person who, at the time of the exportation,

importation, manufacture or arrangements, is a resident of, or is

carrying on business in, Australia.

standard, in relation to therapeutic goods, means any of the

following:

(a) a standard that is constituted by the matters specified in an

order under section 10 that is applicable to the goods;

(b) if the goods are the subject of one or more monographs

(other than a monograph exempt under subsection 3C(1)) in

the British Pharmacopoeia—a standard that is constituted by

the statements (other than statements exempt under

subsection 3C(2)) in those monographs, as interpreted in

accordance with the General Notices section of the British

Pharmacopoeia;

(other than a monograph exempt under subsection 3C(1)) in

the European Pharmacopoeia—a standard that is constituted

by the statements (other than statements exempt under

subsection 3C(2)) in those monographs, as interpreted in

accordance with the General Notices section of the European

Pharmacopoeia;

(d) if the goods are the subject of one or more monographs

(other than a monograph exempt under subsection 3C(1)) in

the United States Pharmacopeia-National Formulary—a

standard that is constituted by the statements (other than

statements exempt under subsection 3C(2)) in those

monographs, as interpreted in accordance with the General

Notices section of the United States Pharmacopeia-National

Formulary;

(e) a homoeopathic standard;

(f) an anthroposophic standard.

Note: See also section 13.

State includes the Australian Capital Territory and the Northern

Territory.

State law means a law of a State, of the Australian Capital

Territory or of the Northern Territory.

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supply includes:

(a) supply by way of sale, exchange, gift, lease, loan, hire or

hire-purchase; and

(b) supply, whether free of charge or otherwise, by way of

sample or advertisement; and

testing the safety or efficacy of therapeutic goods in persons;

and

(d) supply by way of administration to, or application in the

treatment of, a person.

system or procedure pack has the meaning given by section 41BF.

tamper: therapeutic goods are tampered with if:

(a) they are interfered with in a way that affects, or could affect,

the quality, safety or efficacy of the goods; and

(b) the interference has the potential to cause, or is done for the

purpose of causing, injury or harm to any person.

therapeutic device means therapeutic goods (other than

biologicals) consisting of an instrument, apparatus, appliance,

material or other article (whether for use alone or in combination),

together with any accessories or software required for its proper

functioning, which does not achieve its principal intended action

by pharmacological, chemical, immunological or metabolic means

though it may be assisted in its function by such means, but the

expression does not include therapeutic goods declared by the

Secretary, by order published in the Gazette, not to be therapeutic

devices.

therapeutic goods means goods:

(a) that are represented in any way to be, or that are, whether

because of the way in which the goods are presented or for

any other reason, likely to be taken to be:

(i) for therapeutic use; or

(ii) for use as an ingredient or component in the

manufacture of therapeutic goods; or

(iii) for use as a container or part of a container for goods of

the kind referred to in subparagraph (i) or (ii); or

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(b) included in a class of goods the sole or principal use of which

is, or ordinarily is, a therapeutic use or a use of a kind

referred to in subparagraph (a)(ii) or (iii);

and includes biologicals, medical devices and goods declared to be

therapeutic goods under an order in force under section 7, but does

not include:

force under section 7; or

(d) goods in respect of which such an order is in force, being an

order that declares the goods not to be therapeutic goods

when used, advertised, or presented for supply in the way

specified in the order where the goods are used, advertised,

or presented for supply in that way; or

(e) goods (other than goods declared to be therapeutic goods

under an order in force under section 7) for which there is a

standard (within the meaning of subsection 4(1) of the Food

Standards Australia New Zealand Act 1991); or

(f) goods (other than goods declared to be therapeutic goods

under an order in force under section 7) which, in Australia

or New Zealand, have a tradition of use as foods for humans

in the form in which they are presented.

Therapeutic Goods Advertising Code means the code in force

under section 42BAA.

therapeutic use means use in or in connection with:

(a) preventing, diagnosing, curing or alleviating a disease,

ailment, defect or injury in persons; or

(b) influencing, inhibiting or modifying a physiological process

in persons; or

(d) influencing, controlling or preventing conception in persons;

(e) testing for pregnancy in persons; or

(f) the replacement or modification of parts of the anatomy in

persons.

trading corporation means a trading corporation within the

meaning of paragraph 51(xx) of the Constitution.

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United States Pharmacopeia-National Formulary means the

English edition of the publication of that name, including any

additions or amendments, that was in effect immediately before the

commencement of this definition and, if additions or amendments

of that publication are made after that commencement, or new

editions of that publication are published after that commencement,

includes those additions or amendments, or those new editions,

from the effective date published by the United States

Pharmacopeial Convention or any replacement body.

working day, for a person, means any day except:

(a) Saturday or Sunday; or

(b) a day that is a public holiday in the State or Territory in

which the person is located.

(2) For the purposes of this Act, therapeutic goods are taken to be for

use in humans if they are not solely for use in animals.

(2A) The Minister may, by legislative instrument, specify medicines for

the purposes of paragraph (a) of the definition of restricted

medicine in subsection (1).

(2B) The Minister may, by legislative instrument, specify classes of

medicine for the purposes of paragraph (b) of the definition of

restricted medicine in subsection (1).

(3) The Secretary must, at least once in each year, cause to be

published in the Gazette a list of the names of all persons, other

than members of the Australian Federal Police, who are, at the time

of publication, authorised persons.

(4) The provisions of this Act are in addition to, and not in substitution

for, the provisions of any other Act that relate to therapeutic goods.

(5) For the purposes of this Act, the presentation of therapeutic goods

is unacceptable if it is capable of being misleading or confusing as

to the content or proper use or identification of the goods and,

without limiting the previous words in this subsection, the

presentation of therapeutic goods is unacceptable:

(a) if it states or suggests that the goods have ingredients,

components or characteristics that they do not have; or

(b) if a name applied to the goods is the same as the name

applied to other therapeutic goods that are supplied in

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Australia where those other goods contain additional or

different therapeutically active ingredients; or

therapeutically active ingredient; or

(ca) if the therapeutic goods are medicine included in a class of

medicine prescribed by the regulations for the purposes of

this paragraph—if the medicine’s label does not contain the

advisory statements specified under subsection (5A) in

relation to the medicine; or

(d) if a form of presentation of the goods may lead to unsafe use

of the goods or suggests a purpose that is not in accordance

with conditions applicable to the supply of the goods in

Australia; or

(e) in prescribed cases.

(5A) The Minister may, by legislative instrument, specify advisory

statements in relation to medicine for the purposes of

paragraph (5)(ca).

(5B) For the purposes of subsection (5A), the Minister may specify

different advisory statements for different medicines or different

classes of medicine.

(6) A reference in this Act to an annual registration charge, an annual

listing charge, an annual charge for inclusion in the Register or an

annual licensing charge is a reference to such a charge imposed

under the Therapeutic Goods (Charges) Act 1989.

(7) A reference to an offence against this Act includes a reference to:

(a) an offence against the regulations; and

(b) an offence against section 6 of the Crimes Act 1914, or

section 11.1, 11.4 or 11.5 of the Criminal Code, in relation to

an offence against this Act or the regulations; and

Criminal Code in relation to this Act or the regulations.

(7A) For the purposes of this Act, a corresponding State law imposes a

duty on a Commonwealth officer or Commonwealth authority if:

(a) the corresponding State law confers a function or power on

the officer or authority; and

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(b) the circumstances in which the function or power is

conferred give rise to an obligation on the officer or authority

to perform the function or to exercise the power.

3AA Homoeopathic preparations and homoeopathic standards

Homoeopathic preparation

(1) For the purposes of this Act, a homoeopathic preparation is a

preparation:

(a) manufactured from a mother substance; and

(b) manufactured in accordance with a manufacturing procedure

described in a homoeopathic pharmacopoeia.

Homoeopathic standard

(2) For the purposes of this Act, if:

(a) there are therapeutic goods that are a homoeopathic

preparation; and

(b) the goods are the subject of one or more monographs (other

than a monograph exempt under subsection (4)) in the

homoeopathic pharmacopoeia describing the manufacturing

procedure that the preparation was manufactured in

accordance with;

then there is a homoeopathic standard, in relation to the goods,

that is constituted by the statements (other than statements exempt

under subsection (5)) in those monographs, as interpreted in

accordance with any interpretation sections of that homoeopathic

pharmacopoeia.

Specifying publications

(3) The Minister may, by legislative instrument, specify either or both

of the following for the purposes of the definition of homoeopathic

pharmacopoeia in subsection 3(1):

(a) publications;

(b) parts of publications.

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Exempting entire monographs

(4) The Minister may, by legislative instrument, determine that

specified monographs in a specified homoeopathic pharmacopoeia

are exempt for the purposes of paragraph (2)(b).

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

Exempting parts of monographs

(5) The Minister may, by legislative instrument, determine that

specified statements in specified monographs in a specified

homoeopathic pharmacopoeia are exempt for the purposes of

subsection (2).

3AB Anthroposophic preparations and anthroposophic standards

Anthroposophic preparation

(1) For the purposes of this Act, an anthroposophic preparation is a

preparation:

(a) manufactured from a mother substance; and

(b) manufactured in accordance with a manufacturing procedure

described in an anthroposophic pharmacopoeia.

Anthroposophic standard

(2) For the purposes of this Act, if:

(a) there are therapeutic goods that are an anthroposophic

preparation; and

(b) the goods are the subject of one or more monographs (other

than a monograph exempt under subsection (4)) in the

anthroposophic pharmacopoeia describing the manufacturing

procedure that the preparation was manufactured in

accordance with;

then there is an anthroposophic standard, in relation to the goods,

that is constituted by the statements (other than statements exempt

under subsection (5)) in those monographs, as interpreted in

accordance with any interpretation sections of that anthroposophic

pharmacopoeia.

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Specifying publications

(3) The Minister may, by legislative instrument, specify either or both

of the following for the purposes of the definition of

anthroposophic pharmacopoeia in subsection 3(1):

(a) publications;

(b) parts of publications.

Exempting entire monographs

(4) The Minister may, by legislative instrument, determine that

specified monographs in a specified anthroposophic

pharmacopoeia are exempt for the purposes of paragraph (2)(b).

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

Exempting parts of monographs

(5) The Minister may, by legislative instrument, determine that

specified statements in specified monographs in a specified

anthroposophic pharmacopoeia are exempt for the purposes of

subsection (2).

3A Declaration—member of European Community

(1) The Minister may declare, in writing, that a country specified in

the declaration is a member of:

(a) the European Community; or

(b) the European Free Trade Association.

(2) A declaration under subsection (1) must be published in the

Gazette.

3B Declaration—country covered by non-EC/EFTA MRA

(1) The Minister may declare, in writing, that a country specified in

the declaration is covered by the non-EC/EFTA MRA specified in

the declaration.

(2) A declaration under subsection (1) must be published in the

Gazette.

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3C Exempting monographs in pharmacopoeias

Exempting entire monographs

(1) The Minister may, by legislative instrument, determine that

specified monographs in the British Pharmacopoeia, the European

Pharmacopoeia or the United States Pharmacopeia-National

Formulary are exempt for the purposes of paragraph (b), (c) or (d)

of the definition of standard in subsection 3(1).

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

Exempting parts of monographs

(2) The Minister may, by legislative instrument, determine that

specified statements in specified monographs in the British

Pharmacopoeia, the European Pharmacopoeia or the United States

Pharmacopeia-National Formulary are exempt for the purposes of

paragraph (b), (c) or (d) of the definition of standard in

subsection 3(1).

4 Objects of Act

(1) The objects of this Act are to do the following, so far as the

Constitution permits:

(a) provide for the establishment and maintenance of a national

system of controls relating to the quality, safety, efficacy and

timely availability of therapeutic goods that are:

(i) used in Australia, whether produced in Australia or

elsewhere; or

(ii) exported from Australia;

(b) to provide a framework for the States and Territories to adopt

a uniform approach to control the availability and

accessibility, and ensure the safe handling, of poisons in

Australia.

(1A) The reference in paragraph (1)(a) to the efficacy of therapeutic

goods is a reference, if the goods are medical devices, to the

performance of the devices as the manufacturer intended.

(2) This Act is therefore not intended to apply to the exclusion of a law

of a State, of the Australian Capital Territory or of the Northern

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Territory to the extent that the law is capable of operating

concurrently with this Act.

5 Act to bind Crown

This Act binds the Crown in right of the Commonwealth, of each

of the States, of the Australian Capital Territory and of the

Northern Territory, but nothing in this Act renders the Crown

liable to be prosecuted for an offence or to be subject to civil

proceedings for a contravention of a civil penalty provision.

5A Application of the Criminal Code—extended geographical

jurisdiction

Section 15.2 of the Criminal Code (extended geographical

jurisdiction—category B) applies to offences against

subsections 21A(1), (2) and (4) and sections 22A, 41FE, 42E and

42T.

6 Operation of Act

(1) This Act applies to:

(a) things done by corporations; and

(b) things done by natural persons or corporations in so far as

those things are done:

(i) in the course of, or in preparation for, trade or

commerce between Australia and a place outside

Australia, among the States, between a State and a

Territory or between 2 Territories; or

(ii) under a law of the Commonwealth relating to the

provision of pharmaceutical or repatriation benefits; or

(iii) in relation to the Commonwealth or in relation to an

authority of the Commonwealth.

(2) Without limiting the effect of this Act apart from this subsection,

this Act also has the effect it would have if the reference in

paragraph (1)(a) to things done by corporations were confined to

things done by trading corporations for the purposes of their

trading activities.

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6AAA Commonwealth consent to conferral of functions etc. on its

officers and authorities by corresponding State laws

(1) A corresponding State law may confer functions or powers, or

impose duties, on:

(a) a Commonwealth officer; or

(b) a Commonwealth authority.

(2) Subsection (1) does not authorise the conferral of a function or

power, or the imposition of a duty, by a corresponding State law to

the extent to which:

(a) the conferral or imposition, or the authorisation, would

contravene any constitutional doctrines restricting the duties

that may be imposed on Commonwealth officers or

Commonwealth authorities; or

(b) the authorisation would otherwise exceed the legislative

power of the Commonwealth.

(3) Subsection (1) does not extend to a function, power or duty of a

kind specified in regulations made for the purposes of this

subsection.

(4) This Act is not intended to exclude or limit the operation of a

corresponding State law that confers any functions or powers, or

imposes any duties, on a Commonwealth officer or

Commonwealth authority to the extent to which that law:

(a) is consistent with subsections (1) to (3); and

(b) is capable of operating concurrently with this Act.

6AAB When duty imposed

Application

(1) This section applies if a corresponding State law purports to

impose a duty on a Commonwealth officer or Commonwealth

authority.

State legislative power sufficient to support duty

(2) The duty is taken not to be imposed by this Act (or any other law

of the Commonwealth) to the extent to which:

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(a) imposing the duty is within the legislative powers of the State

concerned; and

(b) imposing the duty by the corresponding State law is

consistent with the constitutional doctrines restricting the

duties that may be imposed on a Commonwealth officer or

Commonwealth authority.

Note: If this subsection applies, the duty will be taken to be imposed by force of the corresponding State law (the Commonwealth having consented under section 6AAA to the imposition of the duty by the corresponding State law).

Commonwealth legislative power sufficient to support duty but

State legislative powers are not

(3) If, to ensure the validity of the purported imposition of the duty, it

is necessary that the duty be imposed by a law of the

Commonwealth (rather than by force of the corresponding State

law), the duty is taken to be imposed by this Act to the extent

necessary to ensure that validity.

(4) If, because of subsection (3), this Act is taken to impose the duty, it

is the intention of the Parliament to rely on all powers available to

it under the Constitution to support the imposition of the duty by

this Act.

(5) The duty is taken to be imposed by this Act in accordance with

subsection (3) only to the extent to which imposing the duty:

(a) is within the legislative powers of the Commonwealth; and

(b) is consistent with the constitutional doctrines restricting the

duties that may be imposed on a Commonwealth officer or

Commonwealth authority.

(6) To avoid doubt, neither this Act (nor any other law of the

Commonwealth) imposes a duty on the Commonwealth officer or

Commonwealth authority to the extent to which imposing such a

duty would:

(a) contravene any constitutional doctrine restricting the duties

that may be imposed on a Commonwealth officer or

Commonwealth authority; or

(b) otherwise exceed the legislative power of the

Commonwealth.

(7) Subsections (1) to (6) do not limit section 6AAA.

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6AAC Imposing duty under State law

(1) This section:

(a) applies only for the purposes of the application of the

provisions of this Act or another law of the Commonwealth

(with or without modification) as a law of a State by a

provision of a corresponding State law; and

(b) does not apply for those purposes if the corresponding State

law otherwise provides.

(2) If the corresponding State law purports to impose a duty on a

Commonwealth officer or Commonwealth authority to do a

particular thing, the duty is taken to be imposed by the

corresponding State law to the extent to which imposing the duty:

(a) is within the legislative powers of the State; and

(b) is consistent with the constitutional doctrines restricting the

duties that may be imposed on a Commonwealth officer or

Commonwealth authority.

(3) To avoid doubt, the corresponding State law does not impose the

duty on the Commonwealth officer or Commonwealth authority to

the extent to which imposing the duty would:

(a) contravene any constitutional doctrine restricting the duties

that may be imposed on a Commonwealth officer or

Commonwealth authority; or

(b) otherwise exceed the legislative powers of the State.

(4) If imposing on the Commonwealth officer or Commonwealth

authority the duty to do that thing would:

(a) contravene any constitutional doctrine restricting the duties

that may be imposed on a Commonwealth officer or

Commonwealth authority; or

(b) otherwise exceed the legislative powers of both the State and

the Commonwealth;

the corresponding State law is taken instead to confer on the officer

or authority a power to do that thing at the discretion of the officer

or authority.

6AAD Conferral of jurisdiction on federal courts

If:

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(a) a provision of a corresponding State law purports to apply a

provision of a law of the Commonwealth (the applied

provision) as a law of the State; and

(b) the applied provision purports to confer jurisdiction in

relation to a matter on a federal court;

the jurisdiction in relation to that matter is taken to be conferred on

the court by this section.

6AAE Consequences of State law conferring duty, function or power

on Commonwealth officer or Commonwealth authority

(1) If a corresponding State law confers on a Commonwealth officer or

Commonwealth authority:

(a) the function of including goods in the Register; or

(b) the power to include goods in the Register;

the officer or authority may include the goods in the Register in

accordance with the corresponding State law.

(2) If a corresponding State law authorises or requires a

Commonwealth officer or Commonwealth authority to cancel the

inclusion of goods in the Register, the officer or authority may

cancel the inclusion of the goods in the Register in accordance with

the corresponding State law.

(3) The inclusion of goods in the Register under subsection (1) does

not subject any person to any liability whatever under this Act,

except a liability under Part 6-1.

(4) A Commonwealth officer or Commonwealth authority may make

any notations in the Register that the officer or authority considers

necessary to identify entries that relate to goods included in the

(5) Goods may be included in the Register under subsection (1) even

though the same goods have already been included in the Register

under another provision of this Act.

(6) A reference in this section to the inclusion of goods in the Register

is a reference to the inclusion of the goods:

(a) in the part of the Register for goods known as registered

goods; or

(b) in the part of the Register for goods known as listed goods; or

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(ba) in the part of the Register for biologicals included under

Part 3-2A; or

Chapter 4.

6B Review of certain decisions under State laws

(1) Application may be made to the Administrative Appeals Tribunal

for review of a reviewable State decision.

(2) A decision made by the Secretary in the performance of a function,

or the exercise of a power, conferred by a corresponding State law

is a reviewable State decision for the purpose of this section if:

(a) the law under which the decision was made provides for

review by the Administrative Appeals Tribunal; and

(b) the decision is declared by the regulations to be a reviewable

decision for the purposes of this section.

(3) For the purposes of subsection (1), the Administrative Appeals

Tribunal Act 1975 has effect as if a corresponding State law were

an enactment.

6C Fees payable to Commonwealth under State laws

(1) This section applies to fees payable to the Commonwealth under a

State law in respect of the performance or exercise of functions or

powers conferred by that law on the Secretary.

(2) The Secretary may make arrangements with the appropriate

authority of a State, of the Australian Capital Territory or of the

Northern Territory in relation to the payment to the

Commonwealth of fees to which this section applies.

7 Declaration that goods are/are not therapeutic goods

(1) Where the Secretary is satisfied that particular goods or classes of

goods:

(a) are or are not therapeutic goods; or

(b) when used, advertised, or presented for supply in a particular

way, are or are not therapeutic goods;

the Secretary may, by order published in the Gazette, declare that

the goods, or the goods when used, advertised, or presented for

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28 Therapeutic Goods Act 1989

supply in that way, are or are not, for the purposes of this Act,

therapeutic goods.

(1A) In deciding whether particular goods or classes of goods:

(a) are therapeutic goods; or

(b) when used, advertised, or presented for supply in a particular

way, are therapeutic goods;

the Secretary must disregard paragraphs (e) and (f) of the definition

of therapeutic goods in subsection 3(1).

(2) The Secretary may exercise his or her powers under this section of

his or her own motion or following an application made in writing

to the Secretary.

(3) A declaration under this section takes effect on the day on which

the declaration is published in the Gazette or on such later day as is

specified in the order.

(4) If a declaration under this section:

(a) is a declaration that particular goods or classes of goods are

not therapeutic goods; and

(b) applies wholly or partly to goods that, apart from this section,

would be medical devices;

the goods are not medical devices, or are not medical devices when

used, advertised, or presented for supply in the way specified in the

declaration.

7A Authorised persons

The Secretary may, in writing, authorise any of the following

persons to exercise powers under a specified provision of this Act:

(a) an officer of the Department, of another Department or of an

authority of the Commonwealth;

(b) an officer of:

(i) a Department of State of a State; or

(ii) a Department or administrative unit of the Public

Service of a Territory; or

(iii) an authority of a State or of a Territory;

being a Department, unit or authority that has functions

relating to health matters or law enforcement matters.

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7B Kits

(1) A package and therapeutic goods in the package together constitute

a kit for the purposes of this Act if:

(a) the package and the therapeutic goods are for use as a unit;

and

(b) each item of the therapeutic goods consists of goods that are

registered or listed, are exempt goods in relation to Part 3-2,

are included in the Register under Part 3-2A or are exempt

under subsection 32CA(2) or section 32CB; and

composite pack or a system or procedure pack.

(2) A package and therapeutic goods in the package together constitute

a composite pack if:

(a) the therapeutic goods are of 2 or more kinds; and

(b) the package does not contain any medical devices or

therapeutic devices; and

treatment or as a single course of treatment; and

(d) it is necessary that the therapeutic goods be combined before

administration or that they be administered in a particular

sequence.

(3) To avoid doubt, it is declared that a kit constitutes therapeutic

goods.

7C Secretary may arrange for use of computer programs to make

decisions

(1) The Secretary may arrange for the use, under the Secretary’s

control, of computer programs for any purposes for which the

Secretary may make decisions under this Act or the regulations.

(2) A decision made by the operation of a computer program under

such an arrangement is taken to be a decision made by the

Secretary.

(3) The Secretary may substitute a decision (the substituted decision)

for a decision (the initial decision) made by the operation of a

computer program under such an arrangement if the Secretary is

satisfied that the initial decision is incorrect.

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30 Therapeutic Goods Act 1989

(4) However, the substituted decision may only be made before the

end of the period of 60 days beginning on the day the initial

decision is made.

7D Form for product information for medicine

(1) The Secretary may, by writing, approve a form for product

information in relation to medicine.

(2) The Secretary may approve different forms for different medicines

or different classes of medicine.

8 Power to obtain information with respect to therapeutic goods

(1) The Secretary may, by notice in writing given to a person who has

imported into Australia or has supplied in Australia:

(a) therapeutic goods; or

(b) goods in relation to which the Secretary is considering

making a declaration under section 7;

request the person to give to an officer of the Department identified

in the notice, within such reasonable period as is specified in the

notice, information required by the notice concerning the

composition, indications, directions for use or labelling of the

goods or concerning advertising material relating to the goods.

(1A) A notice under subsection (1) may require the information to be

given:

(a) in writing; or

(b) in accordance with specified software requirements:

(i) on a specified kind of data processing device; or

(ii) by way of a specified kind of electronic transmission.

(2) A person must not fail to comply with a notice given to the person

under this section.

Penalty: 60 penalty units.

(3) Subsection (2) does not apply if the person has a reasonable

excuse.

Note: The defendant bears an evidential burden in relation to the matter in subsection (3). See subsection 13.3(3) of the Criminal Code.

(4) An offence under subsection (2) is an offence of strict liability.

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Preliminary Chapter 1

Section 9

Therapeutic Goods Act 1989 31

Note: For strict liability, see section 6.1 of the Criminal Code.

9 Arrangements with States etc.

(1) The Minister may make arrangements with the appropriate

Minister of a State, of the Australian Capital Territory or of the

Northern Territory for the carrying out by that State or Territory,

on behalf of the Commonwealth, of:

(a) the evaluation of therapeutic goods for registration; or

(aa) the evaluation of a biological, other than a Class 1 biological,

for inclusion in the Register under Part 3-2A; or

(b) the inspection of manufacturers of therapeutic goods; or

(2) An arrangement under this section may provide for the payment to

a State or Territory of amounts in respect of the performance of

functions under the arrangement.

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Chapter 2 Australian Register of Therapeutic Goods

Section 9A

32 Therapeutic Goods Act 1989

Chapter 2—Australian Register of

Therapeutic Goods

9A Australian Register of Therapeutic Goods

(1) The Secretary is to cause to be maintained a register, to be known

as the Australian Register of Therapeutic Goods, for the purpose of

compiling information in relation to, and providing for evaluation

of, therapeutic goods for use in humans.

(2) Subject to subsection (3), the Register is to be kept in such form as

the Secretary determines.

(3) The Register is to contain these 4 parts:

(a) a part for goods to be known as registered goods; and

(b) a part for goods to be known as listed goods; and

(ba) a part for biologicals included in the Register under

Part 3-2A; and

Chapter 4.

(4) The regulations may prescribe:

(a) the therapeutic goods, or the classes of therapeutic goods,

that are required to be included in each part of the Register;

and

(b) the ways in which goods that are included in one part of the

transferred, to another part of the Register; and

registration or listing number may be assigned a different

registration or listing number; and

(ca) the ways in which a biological that has been assigned a

number under subsection 32DB(2), 32DF(2) or 32DN(5) may

be assigned a different number (which may be any

combination of numbers and either or both of letters and

symbols); and

(d) the ways in which medical devices that have been assigned a

device number may be assigned a different device number.

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Section 9B

Therapeutic Goods Act 1989 33

(5) The Minister may, by notice published in the Gazette:

(a) require that specified therapeutic goods be included in the

part of the Register for listed goods; and

(b) specify the conditions subject to which such goods may be

included in that part of the Register.

(6) If the regulations are amended to require any of those goods to be

included in the part of the Register for listed or registered goods,

then the Gazette notice ceases to have effect in respect of the goods

included in the regulations.

9B When registrations or listings of medical devices are taken to be

cancelled

(1) The registration or listing of a medical device to which

subsection 15A(5) applied is taken to be cancelled:

(a) on the second anniversary of the day on which Chapter 4

commences; or

(b) if the medical device is of a kind included in the Register

under Chapter 4 before that second anniversary—when that

inclusion takes effect.

(2) The registration or listing of any other medical device is taken to

be cancelled at the time shown in the table:

Time of cancellation of registration or listing

Circumstances Time

1 That kind of medical device is

included in the Register under

Chapter 4 before 4 October 2007

because of an application finally

determined before that day

When that kind of medical device is included

in the Register under Chapter 4

2 An effective application for a

conformity assessment

certificate relating to that kind of

medical device is made, but not

finally determined, before

4 October 2007

The end of 30 days after the application is

finally determined or, if the application

lapses, the later of the following times (or

either of them if they are the same):

(a) the time the application lapses;

(b) the start of 4 October 2007

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Section 9B

34 Therapeutic Goods Act 1989

Time of cancellation of registration or listing

Circumstances Time

3 An effective application to

include that kind of medical

device in the Register under

Chapter 4 is made, but not

finally determined, before

4 October 2007, and item 2 does

not apply

Whichever one of the following times

applies, or the earlier of them:

(a) the time that kind of medical device is

included in the Register under Chapter 4

(even if that time is before 4 October

2007);

(b) the time the application is finally

determined, if the application is

unsuccessful when it is finally

determined;

or, if the application lapses, the later of the

following times (or either of them if they are

the same):

(d) the start of 4 October 2007

4 None of items 1, 2 and 3 applies The start of 4 October 2007

Note: 4 October 2007 is the fifth anniversary of the day Chapter 4 commenced.

(2A) For the purposes of subsection (2), an application is finally

determined at the first time both the following conditions are met:

(a) a decision has been made under Part 4-4 or 4-5 whether or

not to grant the conformity assessment certificate or include

the kind of medical device in the Register (as appropriate);

(b) there is no longer any possibility of a change in the outcome

of the decision in terms of the grant (or not) of the

conformity assessment certificate or the inclusion (or not) of

the kind of medical device in the Register.

For the purposes of paragraph (b), ignore any possibility of a

discretion being exercised, after the period has ended, to extend a

period for seeking review by a tribunal or court of the decision or

for starting other proceedings (including appeals) arising out of the

application, the decision or the review.

Note: In certain circumstances a decision may be taken to have been made under Part 4-4 or Part 4-5. For example, see section 41EH.

(3) This section does not prevent the Secretary from taking action

under section 30.

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Section 9C

Therapeutic Goods Act 1989 35

9C Inspection of entries in Register

(1) A person in relation to whom therapeutic goods are entered on the

the entry in the Register in relation to the goods.

(2) If the person makes such a request, the Secretary must send to the

person a copy of so much (if any) of that entry as is contained in

any computer database maintained by the Department for purposes

connected with the administration of this Act (other than any part

of that entry that was supplied in confidence by another person).

(3) If the person makes such a request, then, instead of providing a

copy of an entry to the person, the Secretary may, if the request is

for the provision of an electronic copy, provide the information

contained in the entry:

(a) on a data processing device; or

(b) by way of electronic transmission.

9D Variation of entries in Register

(1) The Secretary may:

(a) following a request by a person in relation to whom

therapeutic goods are entered on the Register; or

(b) on the Secretary’s own initiative;

vary the entry in the Register in relation to the goods if the entry

contains information that is incomplete or incorrect.

(2) If:

(a) the person in relation to whom therapeutic goods are

registered or listed has requested the Secretary to vary

information included in the entry in the Register that relates

to the goods; and

(b) the only effect of the variation would be:

(i) to reduce the class of persons for whom the goods are

suitable; or

(ii) to add a warning, or precaution, that does not include

any comparison of the goods with any other therapeutic

goods by reference to quality, safety or efficacy;

the Secretary must vary the entry in accordance with the request.

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Section 9D

36 Therapeutic Goods Act 1989

(2A) Subsection (2), to the extent to which it relates to

subparagraph (2)(b)(i), applies despite subsection 16(1).

(3) If:

(a) the person in relation to whom therapeutic goods are

registered or listed has requested the Secretary to vary

information included in the entry in the Register that relates

to the goods; and

(b) subsection (2) does not apply to the request; and

indicate any reduction in the quality, safety or efficacy of the

goods for the purposes for which they are to be used;

the Secretary may vary the entry in accordance with the request.

(3AA) If:

(a) the person in relation to whom a biological is included in the

included in the entry in the Register that relates to the

biological; and

(b) the only effect of the variation would be:

(i) to reduce the class of persons for whom the biological is

suitable; or

(ii) to add a warning, or precaution, that does not include

any comparison of the biological with any other

therapeutic goods by reference to quality, safety or

efficacy;

the Secretary must vary the entry in accordance with the request.

(3A) If:

(a) the person in relation to whom a biological is included in the

included in the entry in the Register that relates to the

biological; and

(aa) subsection (3AA) does not apply to the request; and

(b) the Secretary is satisfied that the variation requested does not

indicate any reduction in the quality, safety or efficacy of the

biological for the purposes for which it is to be used;

the Secretary may vary the entry in accordance with the request.

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Section 9D

Therapeutic Goods Act 1989 37

(3B) If:

(a) a particular biological ceases to be a biological because of a

determination under subsection 32A(3); and

(b) the biological is included in the Register under Part 3-2A;

the Secretary must move the entry relating to the biological from

the part of the Register for biologicals to whichever other part of

the Register is applicable.

(3C) If:

(a) the person in relation to whom a kind of medical device is

included in the Register has requested the Secretary to vary

information included in the entry in the Register that relates

to the kind of medical device; and

(b) the only effect of the variation would be:

(i) to reduce the class of persons for whom the kind of

medical device is suitable; or

(ii) to add a warning, restriction or precaution, that does not

include any comparison of the kind of medical device

with any other therapeutic goods by reference to quality,

safety or performance;

the Secretary must vary the entry in accordance with the request.

(3D) If:

(a) the person in relation to whom a kind of medical device is

included in the Register has requested the Secretary to vary

information included in the entry in the Register that relates

to the kind of medical device; and

(b) subsection (3C) does not apply to the request; and

indicate any reduction in the quality, safety or performance

of the kind of medical device for the purposes for which it is

to be used;

the Secretary may vary the entry in accordance with the request.

(4) If:

(a) particular therapeutic goods cease to be medical devices

because of a declaration under subsection 41BD(3); and

(b) those goods are included in the Register under Chapter 4 as a

kind of medical device;

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Section 9E

38 Therapeutic Goods Act 1989

the Secretary must move the entry relating to the goods from the

part of the Register for medical devices to whichever other part of

the Register is applicable.

Note: Variations to the Register also occur to give effect to limited cancellations of entries of kinds of medical devices from the Register: see subsection 41GO(2).

Form and manner of requests

(6) The Secretary may, by writing:

(a) approve a form for particular kinds of requests under this

section; and

(b) approve the manner of making particular kinds of requests

under this section.

(7) If:

(a) the Secretary has approved a form for, and the manner of

making, a kind of request under this section; and

(b) either:

(i) the kind of request is one under subsection (3) and

which, under the regulations, must be decided within

175 or 255 working days; or

(ii) the kind of request is one prescribed by the regulations

for the purposes of this subparagraph;

then a request of that kind is not effective unless:

(d) the request contains the information required by that form;

and

(e) the request is made in that manner; and

(f) any prescribed application fee has been paid.

9E Publication of list of goods on Register

The Secretary must, at least once every 12 months, publish a list of

the therapeutic goods included in the Register.

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Standards Part 3-1

Section 10

Therapeutic Goods Act 1989 39

Chapter 3—Medicines and other therapeutic

goods that are not medical devices Note: This Chapter still applies to medical devices while they are registered or listed goods.

Section 9B automatically cancels the registration or listing of those goods over time.

Part 3-1—Standards

10 Determination of standards

(1) The Minister may, by legislative instrument, make an order

determining that matters specified in the order constitute a standard

for therapeutic goods or a class of therapeutic goods identified in

the order (whether or not those goods are the subject of a

monograph in the British Pharmacopoeia, the European

Pharmacopoeia, the United States Pharmacopeia-National

Formulary, a homoeopathic pharmacopoeia or an anthroposophic

pharmacopoeia).

Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

(2) Without limiting the generality of subsection (1), an order

establishing a standard for therapeutic goods may:

(a) be specified by reference to:

(i) the quality of the goods; or

(ii) the quantity of the goods when contained in specified

containers; or

(iii) procedures to be carried out in the manufacture of the

goods; or

(iv) a monograph in the British Pharmacopoeia, the

European Pharmacopoeia, the United States

Pharmacopeia-National Formulary, a homoeopathic

pharmacopoeia or an anthroposophic pharmacopoeia; or

(v) a monograph in another publication approved by the

Minister for the purposes of this subsection; or

(vi) such a monograph as modified in a manner specified in

the order establishing the standard; or

(vii) a standard published by Standards Australia; or

(viii) such other matters as the Minister thinks fit; or

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Part 3-1 Standards

Section 10A

40 Therapeutic Goods Act 1989

(b) require that a matter relating to the standard be determined in

accordance with a particular test; or

identified in the order be labelled or packaged in a manner, or

kept in containers that comply with requirements, specified

in the order.

(3) Without limiting the generality of paragraph (2)(c), the Minister

may, in an order establishing a standard, direct that there be set out,

in a manner specified in the order, on:

(a) therapeutic goods or a class of therapeutic goods identified in

the order; or

(b) a container or package containing therapeutic goods or a

class of therapeutic goods identified in the order; or

identified in the order;

such particulars as are required by the order.

(3A) The Minister may, by legislative instrument, vary or revoke an

order made under subsection (1).

Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

(4) The Minister must not make an order under subsection (1), or vary

or revoke an order made under subsection (1), unless the Minister

has consulted with respect to the proposed action with a committee

established by the regulations to advise the Minister on standards.

10A Application of standards to medical devices

A standard under section 10 does not apply to a medical device

unless Part 3-2 applies to the device.

Note: Section 15A sets out when Part 3-2 applies to a medical device.

13 Special provisions relating to Ministerial standards and default

standards

(1) For the purposes of this Act, if a statement (the main statement) in

a monograph in the British Pharmacopoeia, the European

Pharmacopoeia or the United States Pharmacopeia-National

Formulary refers to a statement in a monograph in another

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Section 13

Therapeutic Goods Act 1989 41

publication, the main statement is taken to include the other

statement.

(2) If:

(a) a standard under section 10 (the Ministerial standard)

applies to therapeutic goods; and

(b) requirements applicable to the goods are specified in a

default standard; and

specified in the Ministerial standard;

the requirements referred to in paragraph (b) are, so far as they are

inconsistent, to be disregarded for the purposes of this Act.

(3) If:

(a) a default standard applies to a class of therapeutic goods; and

(b) another default standard applies to only some of the

therapeutic goods within that class; and

the standard referred to in paragraph (a) does not apply in relation

to the goods referred to in paragraph (b).

(4) If:

(a) therapeutic goods consist, or are represented to consist, of a

mixture of ingredients or of a combination of component

parts; and

(b) a default standard is applicable to one or more of the

ingredients or one or more of the component parts; and

combination;

the standard referred to in paragraph (b) does not apply in relation

to the goods.

(5) If:

(a) therapeutic goods consist, or are represented to consist, of a

mixture of ingredients or of a combination of component

parts; and

(b) there is no standard applicable to the mixture or combination

but a standard is applicable to one or more of the ingredients

or one or more of the component parts;

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Part 3-1 Standards

Section 13A

42 Therapeutic Goods Act 1989

the Minister may, by order published in the Gazette, determine that

the standard does not apply to the goods. The order has effect

accordingly.

(6) An order under subsection (5) is not a legislative instrument.

(7) For the purposes of this Act, in working out at a particular time if

therapeutic goods conform with a default standard applicable to the

goods, if:

(a) after applying subsections (2) to (5), 2 or more default

standards are applicable to the goods at that time; and

(b) at that time, the goods conform with at least one of those

standards but do not conform with at least one of those

standards;

then the default standards that the goods do not conform with are

taken not to apply to the goods at that time.

13A Special provisions relating to homoeopathic standards and

anthroposophic standards

(1) For the purposes of this Act, if a statement (the main statement) in

a monograph in a homoeopathic pharmacopoeia or an

anthroposophic pharmacopoeia refers to a statement in a

monograph in another publication, the main statement is taken to

include the other statement.

(2) If:

(a) a standard under section 10 (the Ministerial standard)

applies to therapeutic goods; and

(b) requirements applicable to the goods are specified in a

homoeopathic standard or an anthroposophic standard; and

specified in the Ministerial standard;

the requirements referred to in paragraph (b) are, so far as they are

inconsistent, to be disregarded for the purposes of this Act.

14 Criminal offences for importing, supplying or exporting goods

that do not comply with standards

Offences relating to importing goods into Australia

(1) A person commits an offence if:

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Section 14

Therapeutic Goods Act 1989 43

(a) the person imports therapeutic goods into Australia; and

(b) the goods are imported without the consent in writing of the

Secretary; and

goods; and

(d) either:

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the goods do not conform with the standard.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person imports therapeutic goods into Australia; and

(b) the goods are imported without the consent in writing of the

Secretary; and

goods; and

(d) the use of the goods, if the goods were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

goods do not conform with the standard.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person imports therapeutic goods into Australia; and

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Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-1 Standards

Section 14

44 Therapeutic Goods Act 1989

(b) the goods are imported without the consent in writing of the

Secretary; and

goods.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Exceptions

(5) Paragraphs (1)(a), (2)(a) and (4)(a) do not apply to goods that do

not conform with a standard applicable to the goods by reason only

of matters relating to labelling or packaging.

Note: A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code.

(5A) Subsection (1), (2) or (4) does not apply if:

(a) the therapeutic goods are a biological; and

(b) the person imports the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

Note: A defendant bears an evidential burden in relation to the matter in subsection (5A): see subsection 13.3(3) of the Criminal Code.

Offences relating to supplying goods for use in Australia

(6) A person commits an offence if:

(a) the person supplies therapeutic goods for use in Australia;

and

(b) the goods are supplied without the consent in writing of the

Secretary; and

goods; and

(d) either:

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the goods do not conform with the standard.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

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Section 14

Therapeutic Goods Act 1989 45

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (9) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(7) A person commits an offence if:

(a) the person supplies therapeutic goods for use in Australia;

and

(b) the goods are supplied without the consent in writing of the

Secretary; and

goods; and

(d) the use of the goods, if the goods were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

goods do not conform with the standard.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(8) Subsection (7) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(9) A person commits an offence if:

(a) the person supplies therapeutic goods for use in Australia;

and

(b) the goods are supplied without the consent in writing of the

Secretary; and

goods.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Exception

(9A) Subsection (6), (7) or (9) does not apply if:

(a) the therapeutic goods are a biological; and

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Section 14

46 Therapeutic Goods Act 1989

(b) the person supplies the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

Note: A defendant bears an evidential burden in relation to the matter in subsection (9A): see subsection 13.3(3) of the Criminal Code.

Offences relating to exporting goods from Australia

(10) A person commits an offence if:

(a) the person exports therapeutic goods from Australia; and

(b) the goods are exported without the consent in writing of the

Secretary; and

goods (other than a standard relating to the labelling of the

goods for supply in Australia); and

(d) either:

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the goods do not conform with the standard.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (13) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(11) A person commits an offence if:

(a) the person exports therapeutic goods from Australia; and

(b) the goods are exported without the consent in writing of the

Secretary; and

goods (other than a standard relating to the labelling of the

goods for supply in Australia); and

(d) the use of the goods, if the goods were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

goods do not conform with the standard.

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Section 14

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Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(12) Subsection (11) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(13) A person commits an offence if:

(a) the person exports therapeutic goods from Australia; and

(b) the goods are exported without the consent in writing of the

Secretary; and

goods (other than a standard relating to the labelling of the

goods for supply in Australia).

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Exception

(13A) Subsection (10), (11) or (13) does not apply if:

(a) the therapeutic goods are a biological; and

(b) the person exports the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

Note: A defendant bears an evidential burden in relation to the matter in subsection (13A): see subsection 13.3(3) of the Criminal Code.

Decisions on whether to give consent

(14) The Secretary must, as soon as practicable after making a decision

to give a consent, cause particulars of the decision to be published

in the Gazette.

(15) The Secretary must, within 28 days after making a decision to

refuse to give a consent, notify the applicant in writing of the

decision and of the reasons for the decision.

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Part 3-1 Standards

Section 14A

48 Therapeutic Goods Act 1989

14A Civil penalties for importing, supplying or exporting goods that

do not comply with standards

Civil penalty relating to importing goods into Australia

(1) A person contravenes this subsection if:

(a) the person imports therapeutic goods into Australia; and

(b) the person does not have the consent in writing of the

Secretary; and

goods (other than by reason of a matter relating to labelling

or packaging).

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Exception

(1A) Subsection (1) does not apply if:

(a) the therapeutic goods are a biological; and

(b) the person imports the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

Civil penalty relating to supplying goods for use in Australia

(2) A person contravenes this subsection if:

(a) the person supplies therapeutic goods for use in Australia;

and

(b) the person does not have the consent in writing of the

Secretary; and

goods.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Exception

(2A) Subsection (2) does not apply if:

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Section 14B

Therapeutic Goods Act 1989 49

(a) the therapeutic goods are a biological; and

(b) the person supplies the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

Civil penalty relating to exporting goods from Australia

(3) A person contravenes this subsection if:

(a) the person exports therapeutic goods from Australia; and

(b) the person does not have the consent in writing of the

Secretary; and

goods (other than a standard relating to the labelling of the

goods for supply in Australia).

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Exception

(3A) Subsection (3) does not apply if:

(a) the therapeutic goods are a biological; and

(b) the person exports the biological after the circumstances

prescribed by the regulations for the purposes of this

paragraph have occurred.

Decisions on whether to give consent

(4) The Secretary must, as soon as practicable after making a decision

to give a consent, cause particulars of the decision to be published

in the Gazette.

(5) The Secretary must, within 28 days after making a decision to

refuse to give a consent, notify the applicant in writing of the

decision and of the reasons for the decision.

14B Application of Customs Act 1901

Where:

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50 Therapeutic Goods Act 1989

(a) the importation or exportation of goods is an offence under

subsection 14(1), (2), (4), (10), (11) or (13) or a

contravention of subsection 14A(1) or (3); and

(b) the Secretary notifies the Chief Executive Officer of Customs

in writing that the Secretary wishes the Customs Act 1901 to

apply to that importation or exportation;

the Customs Act 1901 has effect as if the goods included in that

importation or exportation were goods described as forfeited to the

Crown under section 229 of that Act because they were:

(d) prohibited exports within the meaning of that Act;

as the case requires.

15 Criminal offences relating to breaching a condition of a consent

(1) The consent of the Secretary under section 14 or 14A may be

given:

(a) unconditionally or subject to conditions; or

(b) in respect of particular goods or classes of goods.

(2) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent; and

injury to any person.

Penalty: 2,000 penalty units.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent; and

person.

Penalty: 1,000 penalty units.

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Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4) Subsection (3) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(5) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent.

Penalty: 500 penalty units.

15AA Civil penalty relating to breaching a condition of a consent

A person contravenes this section if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent

imposed under section 15.

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

15AB Conditions relating to exceptional release of biologicals

(1) Regulations made for the purposes of paragraphs 14(9A)(b) and

14A(2A)(b) may also prescribe conditions that apply in relation to

the supply of a biological that occurs after the circumstances

prescribed for the purposes of those paragraphs have occurred.

(2) The conditions prescribed by those regulations must apply only to

the person supplying the biological.

(3) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission results in the breach of any of the

conditions referred to in subsection (1).

Penalty for contravention of this subsection:60 penalty units.

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Part 3-2—Registration and listing of therapeutic

goods

Division 1—Preliminary

15A Application of this Part to medical devices

The general rule

(1) This Part does not apply to a medical device unless this section

provides otherwise.

Previously registered or listed devices

(2) If a medical device is registered goods or listed goods before the

commencement of this section, this Part continues to apply to the

device unless the registration or listing is cancelled.

Note: A registration or listing can be cancelled under section 30, or can be taken to be cancelled under section 9B.

Pending applications

(3) This Part continues to apply to a medical device if:

(a) before the commencement of this section, an application was

made under Part 3 for registration or listing of therapeutic

goods that include that medical device; and

(b) immediately before that commencement, the application was

not yet finally determined; and

before or after that commencement.

However, this Part ceases to apply to the device if, having been

registered goods or listed goods, the registration or listing is

cancelled.

(4) For the purposes of paragraph (3)(b), an application is finally

determined when the application, and any applications for review

or appeals arising out of it, have been finally determined or

otherwise disposed of.

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Applications made within 2 years relating to certain medical

devices

(5) This Part applies to a medical device if:

(a) regulations made for the purposes of this section specified

either:

(i) the medical device classification applying to the kind of

medical device that includes that device; or

(ii) medical devices of that kind; and

(b) during the period of 2 years after the commencement of this

section, an application was made under Part 3-2 for

registration or listing of therapeutic goods that include that

medical device.

However, this Part ceases to apply to the device if, having been

registered goods or listed goods, the registration or listing is

cancelled.

Note: Medical devices that are registered or listed because of this subsection are taken to be cancelled 2 years after Chapter 4 commences, or before then if medical devices of that kind are included in the Register under Chapter 4: see subsection 9B(1).

Medical devices that are exempt goods

(6) This Part applies to a medical device, during the period of 2 years

after the commencement of this section, if the device is exempt

goods.

Existing approvals under section 19

(7) This Part continues to apply to a medical device if:

(a) an approval or authorisation in force under section 19 applies

to the device; and

(b) that approval or authorisation was in force immediately

before the commencement of this section.

New approvals under section 19

(8) This Part applies to a medical device if:

(a) subsection (7) does not apply to the device; and

(b) during the period of 2 years after the commencement of this

section, an approval is granted or an authorisation is given

under section 19 that applies to the device.

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However, this subsection does not apply after the end of that

period.

15B Application of this Part to a biological

(1) Subject to this section, this Part does not apply to a biological on

and after the commencement of this section.

Biologicals currently included in the Register

(2) If, immediately before the commencement of this section,

therapeutic goods that are a biological were registered goods or

listed goods, this Part continues to apply to the biological on and

after that commencement until the time the biological is included

in the Register under Part 3-2A.

Note: Section 32DN deals with including the biological under Part 3-2A.

Pending applications

(3) If:

(a) before the commencement of this section, an application was

made under this Part for the registration or listing of

therapeutic goods that are a biological; and

(b) immediately before that commencement, the application was

not finally determined; and

commencement;

this Part continues to apply to the biological on and after that

commencement until the earliest of the following:

(d) the time the biological is included in the Register under

Part 3-2A;

(e) if the application is unsuccessful when it is finally

determined—the time the application is finally determined;

(f) the time the application is withdrawn;

(g) the time the application lapses.

Note: Section 32DN deals with including the biological under Part 3-2A.

(4) For the purposes of this section, an application is finally

determined when the application, and any applications for review

or appeals arising out of it, have been finally determined or

otherwise disposed of.

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Transitional

(5) This Part applies to a biological on and after the commencement of

this section in relation to things done, or omitted to be done, in

relation to the biological before the commencement of this section.

(6) If this Part continues to apply to a biological during a period

described in subsection (2) or (3), then this Part also applies to the

biological after the end of that period in relation to things done, or

omitted to be done, in relation to the biological during that period.

16 Therapeutic goods and gazetted groups

(1) For the purposes of this Part, therapeutic goods (other than

medicine of the kind to which subsection (1A) applies) are to be

taken to be separate and distinct from other therapeutic goods if

they have:

(a) a different formulation, composition or design specification;

(b) a different strength or size (disregarding pack size); or

(d) a different name; or

(e) different indications; or

(f) different directions for use; or

(g) a different type of container (disregarding container size).

(1A) Medicines that are listable goods (other than export only

medicines) are taken to be separate and distinct from other

therapeutic goods if the medicines have:

(a) different active ingredients; or

(b) different quantities of active ingredients; or

(d) such other different characteristics as the regulations

prescribe;

from the therapeutic goods.

(2) The Secretary may, by order published in the Gazette, determine

that a group of therapeutic goods (not being medical devices or

therapeutic devices) identified in the order is a gazetted therapeutic

goods group because the goods within the group have common

characteristics.

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(3) The Secretary may, by order published in the Gazette, determine

that a group of therapeutic goods (being therapeutic devices)

identified in the order is a gazetted therapeutic devices group

because the goods within the group:

(a) have common characteristics; and

(b) have been produced by the same manufacturer.

(3A) The Secretary may, by order published in the Gazette, determine

that a group of kits identified in the order is a gazetted kits group.

(4) An order under subsection (2), (3) or (3A) may make provision for

or in relation to a matter by applying, adopting or incorporating,

with or without modification, a document as in force from time to

time, if the document is:

(a) published by the Department (whether in electronic form or

otherwise); and

(b) available for sale to the public; and

unit or otherwise) by the public at offices of the Department

specified by the Secretary.

18 Exempt goods

(1) The regulations may, subject to such conditions (if any) as are

specified in the regulations, exempt:

(a) all therapeutic goods, except those included in a class of

goods prescribed for the purposes of this paragraph; or

(b) specified therapeutic goods; or

from the operation of this Part (except section 31A and

sections 31C to 31F).

(2) An exemption in terms of paragraph (1)(a) has effect only in

relation to such classes of persons as are prescribed for the

purposes of this subsection.

(3) Where the regulations revoke an exemption, the revocation takes

effect on the day, not being earlier than 28 days after the day on

which the regulations are made, specified in the regulations.

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18A Exemption because of emergency

Minister’s power

(1) The Minister may exempt from the operation of Division 2 of this

Part:

(a) specified therapeutic goods; or

(b) therapeutic goods in a specified class.

The exemption must be made in writing.

(2) The Minister may exempt goods under subsection (1) only if the

Minister is satisfied that, in the national interest:

(a) the exemption should be made so that the goods may be

stockpiled as quickly as possible in order to create a

preparedness to deal with a potential threat to public health

that may be caused by a possible future emergency; or

(b) the exemption should be made so that the goods can be made

available urgently in Australia in order to deal with an actual

threat to public health caused by an emergency that has

occurred.

When the exemption has effect

(3) The exemption takes effect:

(a) on the day on which the exemption is made; or

(b) on a later day that is specified in the exemption.

(4) The exemption ceases to have effect:

(a) at the end of the period specified by the Minister in the

exemption as the period for which the exemption is to have

effect; or

(b) when the exemption is revoked;

whichever first occurs.

(5) The exemption ceases to have effect in relation to particular

therapeutic goods:

(a) when those goods become registered or listed goods; or

(b) when the Minister varies the exemption by removing those

goods from the exemption;

whichever first occurs.

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(6) If the Minister revokes the exemption as mentioned in

paragraph (4)(b), or varies the exemption as mentioned in

paragraph (5)(b), the revocation or variation takes effect:

(a) if the Minister states in the revocation or variation that the

revocation or variation is necessary to prevent imminent risk

of death, serious illness or serious injury—on the day on

which the revocation or variation is made; or

(b) in any other case—on the day specified by the Minister in the

revocation or variation.

The day specified under paragraph (b) of this subsection must not

be earlier than 28 days after the day on which the revocation or

variation is made.

Note: The revocation or variation must be made in writing, see subsection 33(3) of the Acts Interpretation Act 1901.

Conditions for the exemption

(7) The exemption is subject to conditions specified in the exemption

about any of the following:

(a) the period for which the exemption is to have effect;

(b) the quantity of goods that are exempt;

(d) the persons or class of persons who may import,

manufacture, supply or export those goods;

(e) the supply of those goods (including the persons or class of

persons to whom goods may be supplied for use and the

circumstances under which a stockpile of goods may be

supplied for use);

(f) the storage and security of those goods;

(g) the keeping and disclosure of, and access to, records about

those goods;

(h) the disposal of those goods;

(i) the manner in which any of those goods are to be dealt with

if a condition of the exemption is breached;

(j) any other matters that the Minister thinks appropriate.

Whether or not goods are exempt under this section is not affected

by whether or not there is a breach of a condition of an exemption

under this section in relation to those goods.

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Note 1: A person may commit an offence by breaching a condition of an exemption under this section, see subsections 20(2A) and (2C), 22(7AB) and (7AD), and 30H(1) and (3).

Note 2: A person may also contravene a civil penalty provision, see section 22AA.

(8) The Minister may revoke or vary the conditions (including by

imposing new conditions) after the exemption is made. The

revocation or variation must be made in writing.

(9) A revocation or variation under subsection (8) takes effect:

(a) if the Minister states in the revocation or variation that the

revocation or variation is necessary to prevent imminent risk

of death, serious illness or serious injury—on the day on

which the revocation or variation is made; or

(b) in any other case—on the day specified by the Minister in the

revocation or variation.

The day specified under paragraph (b) must not be earlier than 28

days after the day on which the revocation or variation is made.

Exemption not a legislative instrument

(9A) An exemption under subsection (1) is not a legislative instrument.

Informing persons of exemption etc.

(9B) If the Minister makes an exemption under subsection (1), the

Minister must take reasonable steps to give a copy of the following

to each person covered by paragraph (7)(d):

(a) the exemption;

(b) any revocation or variation of the exemption under this

section.

Notification

(10) The Secretary must cause a document setting out particulars of:

(a) an exemption covered by paragraph (2)(b); and

(b) a revocation or variation under this section of an exemption

covered by paragraph (2)(b);

to be published in the Gazette within 5 working days after the day

on which the Minister makes the exemption, revocation or

variation. However, an exemption, or a revocation or variation, is

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60 Therapeutic Goods Act 1989

not invalid merely because of a failure to comply with this

subsection.

Tabling

(11) The Minister must cause a document setting out particulars of:

(a) an exemption covered by paragraph (2)(b); and

(b) a revocation or variation under this section of an exemption

covered by paragraph (2)(b);

to be tabled before each House of the Parliament within 5 sitting

days of that House after the day on which the Minister makes the

exemption, revocation or variation. However, an exemption, or a

revocation or variation, is not invalid merely because of a failure to

comply with this subsection.

Note: There are other requirements in other parts of this Act about goods exempt under this section:

(a) sections 20, 22 and 22AA (breach of a condition of the exemption);

(b) sections 30F and 30FA (goods not conforming to standards etc.);

(d) section 30H (record keeping);

(e) section 31AA (providing information to the Secretary);

(f) sections 35, 35A, 39 and 41 (manufacturing goods that are exempt under this section);

(g) section 46A (search of premises).

19 Exemptions for special and experimental uses

(1) The Secretary may, by notice in writing, grant an approval to a

person for the importation into, or the exportation from, Australia

or the supply in Australia of specified therapeutic goods that are

not registered goods, listed goods or exempt goods:

(a) for use in the treatment of another person; or

(b) for use solely for experimental purposes in humans;

and such an approval may be given subject to such conditions as

are specified in the notice of approval.

(1A) An approval for the purpose mentioned in paragraph (1)(b) is

subject to the conditions (if any) specified in the regulations. Those

conditions (if any) are in addition to any conditions imposed on the

approval under subsection (1).

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(2) An application for an approval must be made to the Secretary and

must:

(a) in the case of an application for use of the kind referred to in

paragraph (1)(a)—be accompanied by such information

relating to the goods the subject of the application as is

required by the Secretary; and

(b) in the case of an application for use of the kind referred to in

paragraph (1)(b):

(i) be made in writing; and

(ii) be accompanied by such information relating to the

goods the subject of the application as is required by the

Secretary; and

(iii) be accompanied by the prescribed evaluation fee.

(3) Without limiting the conditions to which an approval under

subsection (1) may be made subject, those conditions may include

a condition relating to the charges that may be made for the

therapeutic goods to which the approval relates.

(4) Where an application for an approval is made, the Secretary must,

after having considered the application and, in the case of an

application for the use of therapeutic goods for experimental

purposes in humans, after having evaluated the information

submitted with the application, notify the applicant of the decision

on the application within 28 days of making the decision and, in

the case of a decision not to grant the approval, of the reasons for

the decision.

(4A) The use by a person for experimental purposes in humans of

specified therapeutic goods that are the subject of an approval

granted to someone else under paragraph (1)(b) is subject to the

conditions (if any) specified in the regulations relating to one or

more of the following:

(a) the preconditions on the use of the goods for those purposes;

(b) the principles to be followed in the use of the goods for those

purposes;

goods for those purposes;

(d) the circumstances in which the person must cease the use of

the goods for those purposes.

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(5) The Secretary may, in writing, authorise a specified medical

practitioner to supply:

(a) specified therapeutic goods for use in the treatment of

humans; or

(b) a specified class of such goods;

to the class or classes of recipients specified in the authority.

(5A) An authority may be given subject to the conditions (if any)

specified in the authority.

(5B) The Secretary may impose conditions (or further conditions) on an

authority given to a person under subsection (5) by giving to the

person written notice of the conditions (or further conditions).

(6) An authority under subsection (5) may only be given:

(a) to a medical practitioner included in a class of medical

practitioners prescribed by the regulations for the purposes of

this paragraph; and

(aa) to a medical practitioner who has the approval of an ethics

committee to supply the specified therapeutic goods or the

specified class of such goods; and

(b) in relation to a class or classes of recipients prescribed by the

regulations for the purposes of this paragraph.

Paragraph (aa) does not apply in the exceptional circumstances (if

any) prescribed by the regulations for the purposes of this

subsection.

(7) The regulations may prescribe the circumstances in which

therapeutic goods may be supplied under an authority under

subsection (5).

(9) In this section, medical practitioner means a person who is

registered, in a State or internal Territory, as a medical practitioner.

19A Exemptions where unavailability etc. of therapeutic goods

(1) The Secretary may, by notice in writing, grant an approval to a

person for the importation into Australia, or the supply in

Australia, of specified therapeutic goods if the Secretary is satisfied

that:

(a) registered goods that could act as a substitute for the goods

are unavailable or are in short supply; and

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(b) either:

(i) the goods that are the subject of the application are

registered or approved for general marketing in at least

one foreign country specified by the Secretary in a

determination under subsection (3); or

(ii) an application that complies with section 23 has been

made under that section for registration of the goods;

and

(i) included in Schedule 10 of the Therapeutic Goods

Regulations; or

(ii) specified by the Secretary in a determination under

subsection (4); and

(d) the approval is necessary in the interests of public health.

(2) The Secretary may, by notice in writing, grant an approval to a

person for the importation into Australia, or the supply in

Australia, of specified therapeutic goods if the Secretary is satisfied

that:

(a) registered goods that could act as a substitute for the goods

do not exist; and

(b) an application that complies with section 23 has been made

under that section for registration of the goods; and

(i) included in Schedule 10 of the Therapeutic Goods

Regulations; or

(ii) specified by the Secretary in a determination under

subsection (4); and

(d) the approval is necessary in the interests of public health.

(3) The Secretary may, for the purposes of subparagraph (1)(b)(i),

make written determinations specifying the foreign countries in

which registration or approval for general marketing of the goods

is a prerequisite for approval by the Secretary under this section.

(4) The Secretary may make written determinations specifying the

kinds of goods that can be the subject of an approval under this

section.

(5) Determinations under subsections (3) and (4) are legislative

instruments.

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(6) The Secretary may grant the approval subject to any conditions that

are specified in the notice of approval.

(7) The Secretary may grant the approval for such period as is

specified in the notice of approval.

(8) The approval lapses if:

(a) the period specified in the notice of approval expires; or

(b) a decision has been made under section 25 in relation to the

goods.

(9) The approval lapses if:

(a) the Secretary is satisfied that paragraph (1)(a), (b), (c) or (d),

or paragraph (2)(a), (b), (c) or (d), as the case requires, no

longer applies in relation to the goods, or that a condition of

the approval has been contravened; and

(b) the Secretary has given to the person to whom the approval

was granted a notice stating that the Secretary is so satisfied.

(10) The lapsing of the approval on the expiry of the period specified in

the notice of approval does not prevent another approval being

granted under this section in relation to the goods before the

lapsing of the first-mentioned approval. The other approval may be

expressed to take effect on the expiry of that period.

19B Criminal offences relating to registration or listing etc. of

imported, exported, manufactured and supplied

therapeutic goods

Offences relating to importing, exporting, manufacturing or

supplying goods for use in humans

(1) A person commits an offence if:

(a) the person:

(i) imports into Australia therapeutic goods for use in

humans; or

(ii) exports from Australia therapeutic goods for use in

humans; or

(iii) manufactures in Australia therapeutic goods for use in

humans; or

(iv) supplies in Australia therapeutic goods for use in

humans; and

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(b) none of the following subparagraphs applies in relation to the

goods:

(i) the goods are registered goods or listed goods in relation

to the person;

(ii) the goods are exempt goods;

(iii) the goods are exempt under section 18A;

(iv) the goods are the subject of an approval or authority

under section 19;

(v) the goods are the subject of an approval under

section 19A; and

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A.

Note 3: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person:

(i) imports into Australia therapeutic goods for use in

humans; or

(ii) exports from Australia therapeutic goods for use in

humans; or

(iii) manufactures in Australia therapeutic goods for use in

humans; or

(iv) supplies in Australia therapeutic goods for use in

humans; and

(b) none of the following subparagraphs applies in relation to the

goods:

(i) the goods are registered goods or listed goods in relation

to the person;

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(ii) the goods are exempt goods;

(iii) the goods are exempt under section 18A;

(iv) the goods are the subject of an approval or authority

under section 19;

(v) the goods are the subject of an approval under

section 19A; and

to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note 1: A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person:

(i) imports into Australia therapeutic goods for use in

humans; or

(ii) exports from Australia therapeutic goods for use in

humans; or

(iii) manufactures in Australia therapeutic goods for use in

humans; or

(iv) supplies in Australia therapeutic goods for use in

humans; and

(b) none of the following subparagraphs applies in relation to the

goods:

(i) the goods are registered goods or listed goods in relation

to the person;

(ii) the goods are exempt goods;

(iii) the goods are exempt under section 18A;

(iv) the goods are the subject of an approval or authority

under section 19;

(v) the goods are the subject of an approval under

section 19A.

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Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Defence if person was not the sponsor of the goods

(5) It is a defence to a prosecution under subsection (1), (2) or (4) if

the defendant proves that the defendant was not the sponsor of the

goods at the time of the importation, exportation, manufacture or

supply, as the case may be.

Note: The defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

Exception

(6) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or efficacy of the goods; or

(ii) a matter relating to the labelling or packaging of the

goods; or

(iii) the improper use of the goods; or

(b) harm or injury would not directly result from:

(i) the quality, safety or efficacy of the goods; or

(ii) a matter relating to the labelling or packaging of the

goods; or

(iii) the improper use of the goods.

Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

Application of Customs Act 1901

(7) Where:

(a) the importation or exportation of goods is an offence under

subsection (1), (2) or (4); and

(b) the Secretary notifies the Chief Executive Officer of Customs

in writing that the Secretary wishes the Customs Act 1901 to

apply to that importation or exportation;

the Customs Act 1901 has effect as if the goods included in that

importation or exportation were goods described as forfeited to the

Crown under section 229 of that Act because they were:

(d) prohibited exports within the meaning of that Act;

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as the case requires.

19C Notice required to adduce evidence in support of exception

under subsection 19B(6)

(1) If:

(a) a defendant is committed for trial for an offence against

subsection 19B(1); or

(b) an offence against subsection 19B(1) is to be heard and

determined by a court of summary jurisdiction;

the committing magistrate or the court must:

(d) cause a copy of this section to be given to the defendant.

(2) A defendant must not, without leave of the court, adduce evidence

in support of the exception under subsection 19B(6) unless:

(a) if paragraph (1)(a) applies—more than 21 days before the

trial begins; or

(b) if paragraph (1)(b) applies—more than 21 days before the

hearing of the offence begins;

he or she gives notice of particulars of the exception.

(3) A defendant must not, without leave of the court, call any other

person to give evidence in support of the exception unless:

(a) the notice under subsection (2) includes the name and

address of the person or, if the name and address is not

known to the defendant at the time he or she gives the notice,

any information in his or her possession that might be of

material assistance in finding the person; and

(b) if the name or the address is not included in the notice—the

court is satisfied that the defendant before giving the notice

took, and after giving the notice continued to take, all

reasonable steps to ascertain the name or address; and

defendant subsequently ascertains the name or address or

receives information that might be of material assistance in

finding the person—the defendant immediately gives notice

of the name, address or other information, as the case may

be; and

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(d) if the defendant is told by or on behalf of the prosecutor that

the person has not been found by the name, or at the address,

given by the defendant:

(i) the defendant immediately gives notice of any

information in the defendant’s possession that might be

of material assistance in finding the person; or

(ii) if the defendant later receives any such information—

the defendant immediately gives notice of the

information.

(4) A notice purporting to be given under this section on behalf of the

defendant by his or her legal practitioner is, unless the contrary is

proved, taken as having been given with the authority of the

defendant.

(5) Any evidence tendered to disprove that the exception applies may,

subject to direction by the court, be given before or after evidence

is given in support of the exception.

(6) A notice of particulars of the exception must be given, in writing,

to the Director of Public Prosecutions. A notice is taken as having

been given if it is:

(a) delivered to or left at the Office of the Director of Public

Prosecutions; or

(b) sent by certified mail addressed to the Director of Public

Prosecutions at the Office of the Director of Public

Prosecutions.

(7) In this section:

Director of Public Prosecutions means a person holding office as,

or acting as, the Director of Public Prosecutions under the Director

of Public Prosecutions Act 1983.

19D Civil penalties relating to registration or listing etc. of imported,

exported, manufactured and supplied therapeutic goods

Civil penalty relating to importing, exporting, manufacturing or

supplying goods for use in humans

(1) A person contravenes this subsection if:

(a) the person does any of the following:

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(i) imports into Australia therapeutic goods for use in

humans;

(ii) exports from Australia therapeutic goods for use in

humans;

(iii) manufactures in Australia therapeutic goods for use in

humans;

(iv) supplies in Australia therapeutic goods for use in

humans; and

(b) none of the following subparagraphs applies in relation to the

goods:

(i) the goods are registered goods or listed goods in relation

to the person;

(ii) the goods are exempt goods;

(iii) the goods are exempt under section 18A;

(iv) the goods are the subject of an approval or authority

under section 19;

(v) the goods are the subject of an approval under

section 19A.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Note: A person may commit an offence against subsection 20(2A) or (2C), or may contravene section 22AA (a civil penalty provision), by importing into Australia therapeutic goods that are exempt under section 18A.

Exception if person was not the sponsor of the goods

(2) Subsection (1) does not apply if the person proves that he or she

was not the sponsor of the goods at the time of the importation,

exportation, manufacture or supply, as the case may be.

Civil penalty relating to the importing of registered or listed goods

(3) A person contravenes this subsection if:

(a) therapeutic goods are registered or listed in relation to the

person (other than listed goods that are therapeutic devices);

and

(b) the person imports the goods into Australia; and

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set out on the label of the goods in the prescribed manner

before the goods are supplied in Australia.

Maximum civil penalty:

(a) for an individual—200 penalty units; and

(b) for a body corporate—2,000 penalty units.

Civil penalty relating to the supply of registered or listed goods

(4) A person contravenes this subsection if:

(a) therapeutic goods are registered or listed in relation to the

person (other than listed goods that are therapeutic devices);

and

(b) the person supplies the goods in Australia; and

set out on the label of the goods in the prescribed manner.

Maximum civil penalty:

(a) for an individual—200 penalty units; and

(b) for a body corporate—2,000 penalty units.

Application of Customs Act 1901

(5) Where:

(a) the importation or exportation of goods contravenes

subsection (1); and

(b) the Secretary notifies the Chief Executive Officer of Customs

in writing that the Secretary wishes the Customs Act 1901 to

apply to that importation or exportation;

the Customs Act 1901 has effect as if the goods included in that

importation or exportation were goods described as forfeited to the

Crown under section 229 of that Act because they were:

(d) prohibited exports within the meaning of that Act;

as the case requires.

20 Criminal offences relating to notifying the Secretary and to

importing goods exempt under section 18A

(1B) A person is guilty of an offence if:

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(a) the person is the sponsor of therapeutic goods for use in

humans; and

(b) the person:

(i) imports the goods into Australia; or

(ii) exports the goods from Australia; or

(iii) manufactures the goods in Australia; or

(iv) supplies the goods in Australia; and

manufacture or supply, properly notified to the Secretary

either or both of the following:

(i) the manufacturer of the goods;

(ii) premises used in the manufacture of the goods.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

(1C) For the purposes of paragraph (1B)(c):

(a) a manufacturer is properly notified to the Secretary if:

(i) the manufacturer was nominated, as a manufacturer of

the goods, in an application for the registration or listing

of the goods; or

(ii) the Secretary was subsequently informed in writing that

the manufacturer is a manufacturer of the goods; and

(b) premises are properly notified to the Secretary if:

(i) the premises were nominated, as premises used in the

manufacture of the goods, in an application for the

registration or listing of the goods; or

(ii) the Secretary was subsequently informed in writing that

the premises are used in the manufacture of the goods.

(2A) A person commits an offence if:

(a) the person imports therapeutic goods into Australia; and

(b) the goods are exempt under section 18A; and

Penalty: Imprisonment for 4 years or 240 penalty units, or both.

(2B) Strict liability applies to paragraph (2A)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

(2C) A person commits an offence if:

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(a) the person imports therapeutic goods into Australia; and

(b) the goods are exempt under section 18A; and

Penalty: 60 penalty units.

(2D) An offence under subsection (2C) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

20A Civil penalty relating to the importation, exportation,

manufacture or supply of sponsored goods without

proper notification

(1) A person contravenes this section if:

(a) the person does any of the following:

(i) imports therapeutic goods into Australia;

(ii) exports therapeutic goods from Australia;

(iii) manufactures therapeutic goods in Australia;

(iv) supplies therapeutic goods in Australia; and

(b) the person is the sponsor of the goods for use in humans; and

exportation, manufacture or supply, properly notified to the

Secretary either or both of the following:

(i) the manufacturer of the goods;

(ii) premises used in the manufacture of the goods.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Meaning of properly notified

(2) For the purposes of paragraph (1)(c):

(a) a manufacturer is properly notified to the Secretary if:

(i) the manufacturer was nominated, as a manufacturer of

the goods, in an application for the registration or listing

of the goods; or

(ii) the Secretary was subsequently informed in writing that

the manufacturer is a manufacturer of the goods; and

(b) premises are properly notified to the Secretary if:

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(i) the premises were nominated, as premises used in the

manufacture of the goods, in an application for the

registration or listing of the goods; or

(ii) the Secretary was subsequently informed in writing that

the premises are used in the manufacture of the goods.

21 Offence relating to wholesale supply

A person must not supply in Australia therapeutic goods for use in

humans (other than listable devices), being goods of which the

person is not a sponsor, to another person who is not the ultimate

consumer of the goods unless:

(a) the goods are registered goods or listed goods; or

(b) the goods are exempt goods; or

(ba) the goods are exempt under section 18A; or

section 19; or

(d) the goods are the subject of an approval under section 19A.

Penalty: 120 penalty units.

21A General criminal offences relating to this Part

Offences for making a false or misleading statement

(1) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in or in connection with a certification

of any matter under subsection 26A(2); and

and

(d) either:

(i) the use of the medicine has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the medicine, if the medicine were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

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Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in or in connection with a certification

of any matter under subsection 26A(2); and

and

(d) the use of the medicine, if the medicine were used, would be

likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in or in connection with a certification

of any matter under subsection 26A(2); and

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Offences relating to breaching a condition of registration or listing

of therapeutic goods

(5) A person commits an offence if:

(a) therapeutic goods are registered or listed in relation to the

person; and

(b) the person does an act or omits to do an act; and

listing of the goods; and

(d) the act or omission has resulted in, or will result in, harm or

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

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Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(6) A person commits an offence if:

(a) therapeutic goods are registered or listed in relation to the

person; and

(b) the person does an act or omits to do an act; and

listing of the goods; and

(d) the act or omission is likely to result in harm or injury to any

person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(7) Subsection (6) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(8) A person commits an offence if:

(a) therapeutic goods are registered or listed in relation to the

person; and

(b) the person does an act or omits to do an act; and

listing of the goods.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Offences relating to the supply of therapeutic goods in breach of

authority etc.

(9) A person commits an offence if:

(a) the Secretary has authorised, under subsection 19(5), the

person to supply therapeutic goods; and

(b) the person supplies those goods; and

(i) the supply is not in accordance with the authority; or

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(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 19(7); and

(d) either:

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because:

(i) the supply is not in accordance with the authority; or

(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 19(7).

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(7A) instead: see section 53A.

(10) A person commits an offence if:

(a) the Secretary has authorised, under subsection 19(5), the

person to supply therapeutic goods; and

(b) the person supplies those goods; and

(i) the supply is not in accordance with the authority; or

(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 19(7); and

(d) the use of the goods, if goods were used, would be likely to

result in harm or injury to any person; and

(e) the harm or injury would be likely to result because:

(i) the supply is not in accordance with the authority; or

(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 19(7).

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Penalty: 2,000 penalty units.

(11) Subsection (10) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

Offences relating to using therapeutic goods without approval etc.

(12) A person commits an offence if:

(a) the person uses therapeutic goods; and

(b) the goods are used:

(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans; and

(i) exempt goods; or

(ii) listed goods; or

(iii) registered goods; or

(iv) goods exempt under section 18A; or

(v) goods that are the subject of an approval under

section 19A; and

(d) the goods are not used in accordance with:

(i) an approval or authority under section 19; or

(ii) a condition applicable under regulations made for the

purposes of subsection 19(4A); and

(e) either:

(i) if the person used the goods in the treatment of another

person—the use of the goods has resulted in, or will

result in, harm or injury to that person; or

(ii) if the person used the goods solely for experimental

purposes in humans—the use of the goods has resulted

in, or will result in, harm or injury to any of those

persons.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection 22(8) instead: see section 53A.

(13) A person commits an offence if:

(a) the person uses therapeutic goods; and

(b) the goods are used:

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(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans; and

(i) exempt goods; or

(ii) listed goods; or

(iii) registered goods; or

(iv) goods exempt under section 18A; or

(v) goods that are the subject of an approval under

section 19A; and

(d) the goods are not used in accordance with:

(i) an approval or authority under section 19; or

(ii) a condition applicable under regulations made for the

purposes of subsection 19(4A); and

(e) either:

(i) if the person used the goods in the treatment of another

person—the use of the goods, if the goods were used, is

likely to result in harm or injury to that person; or

(ii) if the person used the goods solely for experimental

purposes in humans—the use of the goods, if the goods

were used, is likely to result in harm or injury to any of

those persons.

Penalty: 2,000 penalty units.

(14) Subsection (13) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

21B General civil penalties relating to this Part

Civil penalty for making a false or misleading statement

(1) A person contravenes this subsection if the person, in or in

connection with a certification of any matter under

subsection 26A(2), makes a statement that is false or misleading in

a material particular.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

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Civil penalty relating to breaching a condition of registration or

listing of therapeutic goods

(2) A person contravenes this subsection if:

(a) therapeutic goods are registered or listed in relation to the

person; and

(b) the person does an act or omits to do an act that breaches a

condition of the registration or listing of the goods.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Civil penalty for falsely representing therapeutic goods

(3) A person contravenes this subsection if:

(a) the person represents therapeutic goods that are not included

in the Register as being so included; or

(b) the person represents therapeutic goods that are not exempt

goods as being exempt goods; or

exempt under section 18A as being goods exempt under that

section; or

(d) the person represents therapeutic goods that are included in

one part of the Register as being included in another part of

the Register; or

(e) the person represents therapeutic goods that are not the

subject of an approval or authority under section 19 as being

the subject of such an approval or authority; or

(f) the person represents therapeutic goods that are not the

subject of an approval under section 19A as being the subject

of such an approval.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

22 General offences relating to this Part

(1) A person must not set out or cause to be set out, on a container or

package that contains therapeutic goods or on a label of goods of

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that kind, a number that purports to be the registration number or

listing number of the goods in relation to a particular person if the

number is not that number.

Penalty: 60 penalty units.

(5) A person commits an offence if:

(a) the person, by any means, advertises therapeutic goods for an

indication; and

(b) the therapeutic goods are included in the Register; and

inclusion.

Penalty: 60 penalty units.

(6) A person must not make a claim, by any means, that the person or

another person can arrange the supply of therapeutic goods (not

being exempt goods or goods exempt under section 18A) that are

not registered goods or listed goods.

Penalty: 60 penalty units.

(7) A person is guilty of an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission results in the breach of:

(i) a condition of an exemption applicable under

regulations made for the purposes of subsection 18(1);

(ii) a condition of an approval under section 19; or

(iii) a condition applicable under regulations made for the

purposes of subsection 19(4A); or

(iv) a condition of an approval under section 19A.

(7AA) An offence against subsection (7) is punishable on conviction by a

fine of not more than 60 penalty units.

(7AB) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to

therapeutic goods; and

(b) the goods are exempt under section 18A; and

exemption; and

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(d) the act or omission is likely to cause a serious risk to public

health.

Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.

Note 1: A person may commit an offence against subsection 20(2A) or (2C), or contravene section 22AA (a civil penalty provision), by breaching a condition of an exemption of therapeutic goods under section 18A that relates to the importation of the goods.

Note 2: A person may commit an offence against subsection 30H(1) or (3) by breaching a condition of an exemption of therapeutic goods under section 18A that relates to records about the goods.

Note 3: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(7AC) Strict liability applies to paragraph (7AB)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

(7AD) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to

therapeutic goods; and

(b) the goods are exempt under section 18A; and

exemption.

Penalty: Imprisonment for 4 years or 240 penalty units, or both.

(7AE) Strict liability applies to paragraph (7AD)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

(7A) A person to whom an authority under subsection 19(5) has been

granted must not supply the therapeutic goods to which the

authority relates except in accordance with:

(a) the authority; and

(aa) the conditions (if any) to which the authority is subject; and

(b) any regulations made for the purpose of subsection 19(7).

Penalty: 500 penalty units.

(8) A person must not use therapeutic goods, other than exempt goods,

listed goods, registered goods, goods exempt under section 18A or

goods that are the subject of an approval under section 19A:

(a) for use in the treatment of another person; or

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(b) for use solely for experimental purposes in humans;

except in accordance with an approval or authority under

section 19 or a condition applicable under regulations made for the

purposes of subsection 19(4A).

Penalty: 500 penalty units.

22AA Civil penalty for breaching a condition of an exemption

A person contravenes this section if:

(a) the person does an act or omits to do an act in relation to

therapeutic goods; and

(b) the goods are exempt under section 18A; and

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

22A Criminal offences for false statements in applications for

registration

(1) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in or in connection with an application

for registration of therapeutic goods; and

and

(d) either:

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

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(2) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in or in connection with an application

for registration of therapeutic goods; and

and

(d) the use of the goods, if the goods were used, would be likely

to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in or in connection with an application

for registration of therapeutic goods; and

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

22B Civil penalty for false statements in applications for registration

A person contravenes this section if the person in or in connection

with an application for registration of therapeutic goods, makes a

statement that is false or misleading in a material particular.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

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Division 2—Registration and listing

23 Applications generally

(1) An application for registration or listing of therapeutic goods must:

(a) be made in accordance with a form approved, in writing, by

the Secretary or in such other manner as is approved, in

writing, by the Secretary; and

(b) be delivered to an office of the Department specified by the

Secretary.

(2) An application is not effective unless:

(a) the prescribed application fee has been paid; and

(b) the applicant has delivered to the office to which the

application was made such information, in a form approved,

in writing, by the Secretary, as will allow the determination

of the application; and

(ba) if the application is for the registration of restricted

medicine—the application is accompanied by product

information, in relation to the medicine, that is in the form

approved under section 7D in relation to the medicine; and

the office to which the application was made a reasonable

number of samples of the goods.

(3) An approval of a form may require or permit an application or

information to be given in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

24 Applications for registration

(1) Where an application is made for the registration of therapeutic

goods in accordance with section 23 and the goods are goods that

are required to be registered, a fee specified in or determined in

accordance with the regulations is payable by the applicant in

respect of the evaluation of the goods for registration, and the

Secretary must notify each such applicant of the amount of the

evaluation fee.

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(2) An application for registration of therapeutic goods lapses if:

(a) any part of the evaluation fee payable in respect of those

goods remains unpaid at the end of the period of 2 months

after the day on which the amount became due and payable;

(b) the application contains information that is inaccurate or

misleading in a material particular; or

applicant in connection with the application, including

information given for the purpose of a requirement under

section 31, is inaccurate or misleading in a material

particular; or

(d) the applicant fails to comply with a requirement under

section 31 to give information consisting of individual patient

data in relation to the goods.

(3) In this section, individual patient data, in relation to therapeutic

goods, means information, derived from clinical trials, relating to

individuals before, during and after the administration of the goods

to those individuals, including, but not limited to, demographic,

biochemical and haematological information.

24A When evaluation fee due for payment

Subject to section 24B, an evaluation fee under section 24 payable

by an applicant is due and payable on the day on which the

applicant is notified of the amount of the evaluation fee.

24B Payment of evaluation fee by instalments

(1) The regulations may provide for the payment of an evaluation fee

under section 24 to be made by such instalments and at such times

as are ascertained in accordance with the regulations, and the

evaluation fee is due and payable accordingly.

(2) Regulations made for the purposes of subsection (1) may provide

that a person is not allowed to pay an evaluation fee under section 24

by instalments if any part of an instalment of:

(a) that or any other evaluation fee under section 24 payable by

the person; or

(b) any assessment fee under section 41LA payable by the

person;

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was unpaid immediately after the time when it became due for

payment.

(3) Subsection (2) does not limit the generality of subsection (1).

24C Recovery of evaluation fee

An evaluation fee under section 24 may be recovered by the

Commonwealth as a debt due to the Commonwealth.

24D Refund of evaluation fee where evaluation not completed within

prescribed period

(1) This section applies to an application under section 23 in relation

to therapeutic goods for the evaluation of which a period is

prescribed under paragraph 63(2)(da).

(2) If:

(a) the applicant has paid the whole of the evaluation fee; and

(b) the evaluation is completed, but not within the period

referred to in subsection (1);

then 25% of the evaluation fee must be refunded to the applicant.

(3) For the purposes of subsection (2), the evaluation is taken to be

completed when the applicant is notified under subsection 25(4) of

the Secretary’s decision on the evaluation.

24E Deemed refusal of application

(1) This section applies in the case of an application under section 23

in relation to therapeutic goods for the evaluation of which a period

is prescribed under paragraph 63(2)(da).

(2) If, at the end of the period referred to in subsection (1), the

evaluation has not been completed, the applicant may give the

Secretary written notice that the applicant wishes to treat the

application as having been refused.

(3) A notice under subsection (2) may be given at any time before the

evaluation is completed.

(4) Where a notice has been given, this Act (except for subsection 60(5))

has effect as if:

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(a) the Secretary had decided not to register the goods the

subject of the application; and

(b) the Minister had made a decision under subsection 60(3)

confirming the decision of the Secretary; and

notice was given to the Secretary under subsection (2).

25 Evaluation and registration of therapeutic goods

(1) If an application is made for the registration of therapeutic goods in

relation to a person in accordance with section 23, the Secretary

must evaluate the goods for registration having regard to:

(d) whether the quality, safety and efficacy of the goods for the

purposes for which they are to be used have been

satisfactorily established; and

(da) if:

(i) the applicant is applying for the registration of restricted

medicine; or

(ii) the applicant is applying for the registration of medicine

(other than restricted medicine) and the applicant has

been given a notice in writing by the Secretary requiring

the applicant to give to the Secretary product

information, in relation to the medicine, that is in the

form approved under section 7D in relation to the

medicine;

the product information given by the applicant in relation to

the medicine; and

(e) whether the presentation of the goods is acceptable; and

(f) whether the goods conform to any standard applicable to the

goods, or any requirements relating to advertising applicable

under Part 5-1 or under the regulations; and

(g) if a step in the manufacture of the goods has been carried out

outside Australia—whether the manufacturing and quality

control procedures used in the manufacture of the goods are

acceptable; and

(h) if the goods have been manufactured in Australia—whether

the goods have been manufactured in accordance with

Part 3-3; and

(j) whether the goods contain substances that are prohibited

imports for the purposes of the Customs Act 1901; and

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(ja) whether all of the manufacturers of the goods are nominated

as manufacturers of the goods in the application; and

(k) such other matters (if any) as the Secretary considers

relevant.

Note: The Secretary must not use protected information when evaluating therapeutic goods for registration: see section 25A.

(2) In making a decision for the purposes of paragraph (1)(g), the

matters that may be taken into account include:

(a) whether the applicant has provided:

(i) if the goods are not therapeutic devices and a step in the

manufacture of the goods has been carried out in a

country that is a member of the European Community

or a member of EFTA—an EC/EFTA attestation of

conformity in relation to the goods; or

(ia) if the goods are not therapeutic devices and a step in the

manufacture of the goods has been carried out in a

country declared by the Minister under section 3B to be

covered by a non-EC/EFTA MRA—a non-EC/EFTA

attestation of conformity, for the non-EC/EFTA MRA,

in relation to the goods; or

(ii) in any other case—an acceptable form of evidence from

a relevant overseas authority establishing that the

manufacture of the goods is of an acceptable standard;

and

(b) whether the applicant has agreed to provide, where the

Secretary considers inspection of the manufacturing

procedures used in the manufacture of the goods to be

necessary:

(i) funds for the carrying out of that inspection by the

Department; and

(ii) evidence that the manufacturer has agreed to such an

inspection.

(2A) An evaluation under this section of goods in relation to which a

period has been prescribed under paragraph 63(2)(da) must be

completed within that period.

(2B) If therapeutic goods are exempt from the operation of Part 3-3 or a

person is exempt from the operation of that Part in relation to the

manufacture of the goods, subsection (1) has effect, in relation to

the goods, as if paragraph (h) were omitted.

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(2C) If a person is exempt from the operation of Part 3-3 in relation to a

step in the manufacture of therapeutic goods, subsection (1) has

effect, in relation to the goods, as if the reference in paragraph (h)

to Part 3-3 were a reference to that Part to the extent that it applies

to that person in relation to the manufacture of the goods.

(2D) If:

(a) therapeutic goods were made outside Australia; and

(b) had the goods been made in Australia, they would have been

exempt from the operation of Part 3-3;

subsection (1) has effect, in relation to the goods, as if

paragraph (g) were omitted.

(2E) A decision for the purposes of paragraph (1)(g) may also take into

account any information provided to the Secretary by a health

authority of a Convention country and relating to:

(a) the general standards of manufacturing practice of a

particular manufacturer; or

(b) the specific standards of manufacture or control adopted by a

particular manufacturer in relation to particular goods.

(2F) For the purposes of subsection (2E), a Convention country is a

country that is a party to the Mutual Recognition Convention.

(2G) Information referred to in subsection (2E) and provided in

accordance with the Mutual Recognition Convention is to be

treated as equivalent to information obtained as a result of an

inspection under Part 3-3 of this Act.

(3) If:

(a) the therapeutic goods are therapeutic devices; and

(b) the evaluation of the goods for registration has been

completed;

the Secretary must:

evaluation within 28 days of the making of the decision and,

in the case of a decision not to register the goods, of the

reasons for the decision; and

(d) if the decision is to register the goods—include the goods in

the Register and give the applicant a certificate of

registration.

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(4) If:

(a) the therapeutic goods are not therapeutic devices; and

(b) the evaluation of the goods for registration has been

completed;

the Secretary must:

evaluation within 28 days of the making of the decision and,

in the case of a decision not to register the goods, of the

reasons for the decision; and

(d) if the decision is to register the goods:

(i) notify the applicant in writing that the goods will be

included in the Register if the applicant gives the

Secretary either the certificate required under

subsection 26B(1) or a notice (in accordance with a

form approved, in writing, by the Secretary) that a

certificate under that subsection is not required in

relation to the application; and

(ia) if the goods are restricted medicine or the goods are

medicine in respect of which the applicant has been

given a notice of the kind referred to in

subparagraph (1)(da)(ii)—notify the applicant in writing

of the product information that is approved in relation to

the medicine; and

(ii) include the goods in the Register and give the applicant

a certificate of registration if the applicant gives the

Secretary either the certificate required under

subsection 26B(1) or a notice (in accordance with a

form approved, in writing, by the Secretary) that a

certificate under that subsection is not required in

relation to the application.

To avoid doubt, if the applicant gives the Secretary the certificate

required under subsection 26B(1) or a notice that a certificate

under that subsection is not required in relation to the application,

the Secretary must include the goods in the Register under

subparagraph (d)(ii) without inquiring into the correctness of the

certificate or the notice.

(5) The registration of therapeutic goods commences on the day

specified for the purpose in the certificate of registration.

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25AA Approved product information for medicine

(1) If:

(a) the Secretary includes restricted medicine in the Register in

relation to a person under subparagraph 25(4)(d)(ii); or

(b) an applicant for the registration of medicine (other than

restricted medicine) is given a notice of the kind referred to

in subparagraph 25(1)(da)(ii) and the Secretary includes the

medicine in the Register in relation to the applicant under

subparagraph 25(4)(d)(ii);

the product information that is approved under this section in

relation to the medicine is the product information referred to in

subparagraph 25(4)(d)(ia).

Note: Subsection (4) deals with variation of the product information.

Transitional

(2) If:

(a) at the start of the day the first instrument made under

subsection 3(2A) or (2B) takes effect, there is medicine

included in the Register in relation to a person; and

(b) before that day, the Secretary, in a notice given under

subsection 25(4) to the person in relation to the registration

of the medicine, specified the product information that was

approved by the Secretary in relation to the medicine;

then that product information (including as varied before that day)

is, on and after that day, the product information that is approved

under this section in relation to the medicine.

Note: Subsection (4) deals with variation of the product information.

(3) If:

(a) before the day the first instrument made under

subsection 3(2A) or (2B) takes effect, a person made an

application to include medicine in the Register; and

(b) before that day and in relation to that application, the

Secretary, in a notice given under subsection 25(4) to the

person, specified the product information that was approved

by the Secretary in relation to the medicine; and

Secretary includes the medicine in the Register in relation to

the person under subparagraph 25(4)(d)(ii);

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then that product information (including as varied before that

inclusion) is, on and after the day the registration of the medicine

commences, the product information that is approved under this

section in relation to the medicine.

Note: Subsection (4) deals with variation of the product information.

Variations

(4) If:

(a) there is medicine included in the Register in relation to a

person and there is product information approved under this

section in relation to the medicine; and

(b) either:

(i) under section 9D, the Secretary varies the entry in the

(ii) there is a change in the conditions to which the

inclusion of the medicine is subject; and

satisfied that a variation to that product information is

required;

the Secretary may, by notice in writing given to the person, make

any variations that the Secretary considers appropriate to the

product information that is approved in relation to the medicine.

(5) To avoid doubt, if product information that is approved in relation

to medicine is varied under this section, that product information,

as varied, becomes the product information that is approved under

this section in relation to the medicine.

25A When the Secretary must not use protected information

(1) When evaluating therapeutic goods for registration, the Secretary

must not use information about other therapeutic goods that is

protected information.

(2) Information is protected information if:

(a) the information was given to the Secretary in relation to an

application to register therapeutic goods (the new goods):

(i) not being therapeutic devices; and

(ii) consisting of, or containing, an active component; and

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(b) the information is about the active component and is not

available to the public; and

(i) no other therapeutic goods consisting of, or containing,

that active component were included in the Register;

and

(ii) no such therapeutic goods had been included in the

(d) the new goods became registered on or after the

commencement of this subsection; and

(e) 5 years have not passed since the day the new goods became

registered; and

(f) the person in relation to whom the new goods are registered

has not given the Secretary permission in writing for the

Secretary to use the information.

(3) For the purposes of subsection (2), an active component, in

relation to therapeutic goods, is a substance that is, or one of the

substances that together are, primarily responsible for the

biological or other effect identifying the goods as therapeutic

goods.

25B Registration of therapeutic device to which EC/EFTA

attestation of conformity applies

(1) If:

(a) an application is made in accordance with section 23 for the

registration of a therapeutic device in relation to a person;

and

(b) the applicant gives to the Secretary an EC/EFTA attestation

of conformity as to the matters that would require evaluation

under subsection 25(1) if that subsection applied in relation

to the device;

the Secretary must register the device unless the Secretary

considers that the device may compromise the health or safety of

users.

(2) The Secretary must notify the applicant in writing of his or her

decision on the application within 28 days of the making of the

decision. If the Secretary decides not to register the device, the

notice must contain the reasons for that decision.

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(3) If the Secretary decides to register the device, the Secretary must:

(a) include the device in the Register; and

(b) give to the applicant a certificate of registration.

(4) The registration of the device commences on the day specified for

the purpose in the certificate of registration.

26 Listing of therapeutic goods

(1) Where:

(a) an application is made for the listing of therapeutic goods in

relation to a person in accordance with section 23; and

(aa) if goods are not therapeutic devices—the application is

accompanied by either:

(i) the certificate required under subsection 26B(1); or

(ii) a notice (in accordance with a form approved, in

writing, by the Secretary) that a certificate under that

subsection is not required in relation to the application;

and

(b) the person has complied with any requirements made by the

Secretary under section 31 in relation to the goods; and

(ba) the goods are not goods which may be listed under

section 26A;

then, subject to this section and section 26AA, the Secretary is not

to refuse to list the goods in relation to the person except where the

Secretary is satisfied that:

(d) the goods are not safe for the purposes for which they are to

be used; or

(e) the presentation of the goods is unacceptable; or

(f) the goods do not conform to a standard applicable to the

goods or to a requirement relating to advertising applicable

under Part 5-1 or under the regulations; or

(g) if a step in the manufacture of the goods (not being

therapeutic devices other than devices prescribed for the

purposes of this paragraph) has been carried out outside

Australia—the manufacturing and quality control procedures

used in the manufacture of the goods are not acceptable; or

(h) if the goods have been manufactured in Australia—the goods

have been manufactured contrary to Part 3-3; or

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(j) if the goods have been manufactured in Australia, or

imported into Australia, solely for export—a relevant

authority of the country to which the goods are to be

exported has not confirmed its willingness to accept the

goods and:

(i) the goods have been refused registration or listing for

supply in Australia; or

(ii) the Secretary requires such a confirmation for a reason

other than because the goods have been refused

registration or listing; or

(k) the goods do not comply with prescribed quality or safety

criteria; or

(m) the goods contain substances that are prohibited imports for

the purposes of the Customs Act 1901; or

(n) one or more of the manufacturers of the goods are not

nominated as manufacturers of the goods in the application.

(1AA) If:

(a) a medicine (the original medicine) is included in the Register

in relation to a person; and

(b) the person makes an application under section 23 for the

listing of a medicine (the new medicine) under this section;

and

satisfied in relation to the application; and

(d) the Secretary is satisfied that the new medicine has the same

characteristics as the original medicine apart from the

characteristics specified in an instrument under

subsection (1AB);

the Secretary may list the new medicine in relation to the person.

(1AB) The Minister may, by legislative instrument, specify characteristics

for the purposes of paragraph (1AA)(d).

(1A) To avoid doubt, if:

(a) an application is made for the listing of therapeutic goods in

relation to a person in accordance with section 23; and

(b) the application is accompanied by either:

(i) the certificate required under subsection 26B(1); or

(ii) a notice that a certificate under that subsection is not

required in relation to the application; and

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the Secretary must list the goods under subsection (1) without

inquiring into the correctness of the certificate or the notice.

(2) In making a decision for the purposes of paragraph (1)(g), the

matters that may be taken into account include:

(a) whether the applicant has provided:

(i) if the goods are not therapeutic devices and a step in the

manufacture of the goods has been carried out in a

country that is a member of the European Community

or a member of EFTA—an EC/EFTA attestation of

conformity in relation to the goods; or

(ia) if the goods are not therapeutic devices and a step in the

manufacture of the goods has been carried out in a

country declared by the Minister under section 3B to be

covered by a non-EC/EFTA MRA—a non-EC/EFTA

attestation of conformity, for the non-EC/EFTA MRA,

in relation to the goods; or

(ii) in any other case—an acceptable form of evidence from

a relevant overseas authority establishing that the

manufacture of the goods is of an acceptable standard;

and

(b) whether the applicant has agreed to provide, where the

Secretary considers inspection of the manufacturing

procedures used in the manufacture of the goods to be

necessary:

(i) funds for the carrying out of that inspection by the

Department; and

(ii) evidence that the manufacturer has agreed to such an

inspection.

(2A) If therapeutic goods are exempt from the operation of Part 3-3 or a

person is exempt from the operation of that Part in relation to the

manufacture of the goods, subsection (1) has effect, in relation to

the goods, as if paragraph (h) were omitted.

(2B) If a person is exempt from the operation of Part 3-3 in relation to a

step in the manufacture of therapeutic goods, subsection (1) has

effect, in relation to the goods, as if the reference in paragraph (h)

to Part 3-3 were a reference to that Part to the extent that it applies

to that person in relation to the manufacture of the goods.

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(2C) If:

(a) therapeutic goods were made outside Australia; and

(b) had the goods been made in Australia, they would have been

exempt from the operation of Part 3-3;

subsection (1) has effect, in relation to the goods, as if

paragraph (g) were omitted.

(2D) A decision for the purposes of paragraph (1)(g) may also take into

account any information provided to the Secretary by a health

authority of a Convention country and relating to:

(a) the general standards of manufacturing practice of a

particular manufacturer; or

(b) the specific standards of manufacture or control adopted by a

particular manufacturer in relation to particular goods.

(2E) For the purposes of subsection (2D), a Convention country is a

country that is a party to the Mutual Recognition Convention.

(2F) Information referred to in subsection (2D) and provided in

accordance with the Mutual Recognition Convention is to be

treated as equivalent to information obtained as a result of an

inspection under Part 3-3 of this Act.

(3) Where an application is made, the Secretary must notify the

applicant in writing of his or her decision on the application within

28 days of the making of the decision and, in the case of a decision

not to list the goods, of the reasons for the decision.

(4) As soon as practicable after an applicant has been informed that

therapeutic goods in respect of which an application was made are

acceptable for listing, the Secretary must give to the applicant a

certificate of listing of the goods, and the listing of the goods

commences on the day specified for the purpose in the certificate.

26AA Listing of therapeutic device to which EC/EFTA attestation of

conformity applies

(1) If:

(a) an application is made in accordance with section 23 for the

listing of a therapeutic device in relation to a person; and

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(b) the applicant gives to the Secretary an EC/EFTA attestation

of conformity as to the matters specified in paragraphs

26(1)(c) to (m) in relation to the device;

the Secretary must list the device in relation to the person unless

the Secretary considers that the device may compromise the health

or safety of users.

(2) The Secretary must notify the applicant in writing of his or her

decision within 28 days of the making of the decision. If the

Secretary decides not to list the device, the notice must contain the

reasons for that decision.

(3) If the Secretary decides to list the device, the Secretary must:

(a) include the device in the Register; and

(b) give to the applicant a certificate of listing.

(4) The listing of the device commences on the day specified for the

purpose in the certificate of listing.

26A Listing of certain medicines

(1) If:

(a) an application is made for the listing of medicine in relation

to a person in accordance with section 23; and

(b) the application is accompanied by either:

(i) the certificate required under subsection 26B(1); or

(ii) a notice (in accordance with a form approved, in

writing, by the Secretary) that a certificate under that

subsection is not required in relation to the application;

and

subsections (2A), (3) and (4A) have been complied with; and

(d) the medicine is not export only medicine; and

(e) the medicine is not one that has previously had its

registration or listing cancelled;

the Secretary must list the medicine in relation to the person.

(1A) To avoid doubt, if:

(a) an application is made for the listing of a medicine in relation

to a person in accordance with section 23; and

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(b) the application is accompanied by either:

(i) the certificate required under subsection 26B(1); or

(ii) a notice that a certificate under that subsection is not

required in relation to the application; and

the Secretary must list the medicine under subsection (1) without

inquiring into the correctness of the certificate or the notice.

(2) The applicant must certify that:

(a) the medicine is eligible for listing; and

(b) the medicine is safe for the purposes for which it is to be

used; and

(ca) the medicine does not contain an ingredient that is not

specified in a determination under paragraph 26BB(1)(a);

and

(cb) if a determination under paragraph 26BB(1)(b) specifies

requirements in relation to ingredients being contained in the

medicine—none of the requirements have been contravened;

and

(d) the medicine conforms to every standard (if any) applicable

to the medicine and to every requirement (if any) relating to

advertising applicable under Part 5-1 or under the

regulations; and

(e) if the medicine has been manufactured in Australia—each

step in the manufacture of the medicine has been carried out

by a person who is the holder of a licence to carry out that

step; and

(f) the medicine complies with all prescribed quality or safety

criteria that are applicable to the medicine; and

(fa) the medicine’s specifications comply with any requirements

that are prescribed by the regulations for the purposes of this

paragraph and that are applicable to the medicine; and

(fb) the medicine’s label:

(i) complies with any requirements that are prescribed by

the regulations for the purposes of this subparagraph

and that are applicable to the medicine; and

(ii) does not make a claim that is inconsistent with any

claim made by the applicant in relation to the medicine

in, or in connection with, the application; and

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(fc) the applicant holds information or evidence showing the

medicine’s specifications will be maintained under the

conditions set out on the medicine’s label until the

medicine’s expiry date; and

(g) the medicine does not contain substances that are prohibited

imports for the purposes of the Customs Act 1901; and

(h) all the manufacturers of the medicine are nominated as

manufacturers in the application; and

(i) the applicant has, with manufacturers of the medicine who

are manufacturers of the prescribed kind, written agreements

containing such matters as are prescribed; and

(j) the applicant holds information or evidence to support any

claim that the applicant makes relating to the medicine; and

(k) the information included in or with the application is correct.

(2A) The applicant must also certify any other matters prescribed by the

regulations for the purposes of this subsection.

(3) Subject to subsection (7), if a step in the manufacture of the

medicine has been carried out outside Australia, the Secretary must

have certified, prior to the application being made, that the

manufacturing and quality control procedures used in each such

step are acceptable.

(4) In deciding whether so to certify for the purposes of subsection (3),

the matters that may be taken into account include:

(a) whether the applicant has provided:

(i) if a step in the manufacture of the medicine has been

carried out in a country that is a member of the

European Community or a member of EFTA—an

EC/EFTA attestation of conformity in relation to the

medicine; or

(ia) if a step in the manufacture of the medicine has been

carried out in a country declared by the Minister under

section 3B to be covered by a non-EC/EFTA MRA—a

non-EC/EFTA attestation of conformity, for the

non-EC/EFTA MRA, in relation to the medicine; or

(ii) in any other case—an acceptable form of evidence from

a relevant overseas authority establishing that the

manufacture of the medicine is of an acceptable

standard; and

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(b) whether the applicant has agreed to provide, if the Secretary

considers inspection of the manufacturing procedures used in

the manufacture of the medicine to be necessary:

(i) funds for the carrying out of that inspection by the

Department; and

(ii) evidence that the manufacturer has agreed to such an

inspection; and

made by the Secretary under section 31 in relation to the

manufacture or preparation of the medicine.

(4A) If the medicine includes any ingredient of animal origin, the

Secretary must have certified, prior to the application being made,

that he or she is satisfied of the safety of the ingredient.

(5) If a medicine is exempt from the operation of Part 3-3 or a person

is exempt from the operation of that Part in relation to the

manufacture of the medicine, subsection (2) has effect, in relation

to the medicine, as if paragraph (2)(e) were omitted.

(6) If a person (the manufacturer) is exempt from the operation of

Part 3-3 in relation to a step in the manufacture of a medicine,

subsection (2) has effect, in relation to the medicine, as if the

reference in paragraph (2)(e) to a person who is the holder of a

licence were a reference to the manufacturer to the extent that

Part 3-3 applies to the manufacturer in relation to the manufacture

of the medicine.

(7) If:

(a) a medicine was made outside Australia; and

(b) had the medicine been made in Australia, it would have been

exempt from the operation of Part 3-3;

subsection (3) does not apply in relation to the medicine.

(9) As soon as practicable after a medicine has been listed under this

section, the Secretary must give to the applicant a certificate of

listing of the medicine. The listing of the medicine commences on

the day specified for the purpose in the certificate.

26B Certificates required in relation to patents

(1A) A certificate is required under subsection (1) in relation to an

application for registration or listing of therapeutic goods only if:

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(a) the applicant is required to submit evidence or information to

establish the safety or efficacy of the goods as part of the

process of applying for registration or listing; and

(b) in order to satisfy that requirement, the applicant relies (in

whole or in part) on evidence or information that another

person submitted to the Secretary:

(i) to establish the safety or efficacy of other therapeutic

goods that have already been registered or listed; and

(ii) as part of the process of applying for the registration or

listing of those other goods.

(1) The certificate required under this subsection is either:

(a) a certificate to the effect that the applicant, acting in good

faith, believes on reasonable grounds that it is not marketing,

and does not propose to market, the therapeutic goods in a

manner, or in circumstances, that would infringe a valid

claim of a patent that has been granted in relation to the

therapeutic goods; or

(b) a certificate to the effect that:

(i) a patent has been granted in relation to the therapeutic

goods; and

(ii) the applicant proposes to market the therapeutic goods

before the end of the term of the patent; and

(iii) the applicant has given the patentee notice of the

application for registration or listing of the therapeutic

goods under section 23.

The certificate must be signed by, or on behalf of, the applicant and

must be in a form approved by the Secretary.

(2) A person is guilty of an offence if:

(a) the person gives a certificate required under subsection (1);

and

(b) the certificate is false or misleading in a material particular.

Penalty: 1,000 penalty units.

(3) For the purposes of this section, a patent is taken to have been

granted in relation to therapeutic goods if marketing the goods

without the authority of the patentee would constitute an

infringement of the patent.

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(4) In this section:

patent has the same meaning as in the Patents Act 1990.

26BA Approved form for notices

An approval of a form for a notice for the purposes of

subsection 25(4), 26(1) or 26A(1) may require or permit the notice

to be given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

26BB Permissible ingredients

(1) The Minister may, by legislative instrument, make a determination

specifying either or both of the following:

(a) ingredients;

(b) for some or all of those ingredients—requirements in relation

to those ingredients being contained in medicine.

Note: A person seeking the listing of a medicine under section 26A must certify that:

(a) the medicine does not contain an ingredient that is not specified in the determination; and

(b) none of the requirements specified in the determination in relation to ingredients being contained in the medicine have been contravened.

Requirements

(2) The requirements referred to in paragraph (1)(b) may relate to

particular ingredients not being contained in particular medicine.

(3) The requirements referred to in paragraph (1)(b) may relate to

permitted concentrations or permitted total amounts of ingredients.

(4) Subsections (2) and (3) do not limit paragraph (1)(b).

(5) A determination under paragraph (1)(b) may make different

provision for different classes of medicine.

Limitations on determination under subsection (1)

(6) The Minister may, by legislative instrument, make a determination

specifying either or both of the following:

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(a) ingredients that must not be specified under paragraph (1)(a);

(b) requirements that must not be specified under

paragraph (1)(b) in relation to ingredients being contained in

medicine.

(7) A determination under paragraph (6)(b) may make different

provision for different classes of medicine.

Incorporation of instruments

(8) Despite subsection 14(2) of the Legislative Instruments Act 2003, a

determination under this section may make provision in relation to

a matter by applying, adopting or incorporating any matter

contained in an instrument or other writing as in force or existing

from time to time.

26BC Variation of determination under section 26BB—Minister’s

initiative

The Minister may, on his or her own initiative and by legislative

instrument, vary a determination under section 26BB.

26BD Variation of determination under section 26BB—application

by person

(1) A person may apply to the Minister for a variation of a

determination under subsection 26BB(1).

(2) An application under subsection (1) must:

(a) be made in accordance with a form approved by the

Secretary; and

(b) set out the variation sought; and

form; and

(d) be accompanied by the prescribed application fee.

(3) If an application is made under subsection (1) and any applicable

prescribed evaluation fee has been paid, the Minister may, by

legislative instrument, vary the determination.

(3A) In deciding whether to vary the determination, the Minister must

have regard to the quality and safety of the ingredients concerned.

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This subsection does not limit the matters to which the Minister

may have regard to in deciding whether to vary the determination.

Further information

(4) The Minister may, by notice in writing given to the person, require

the person to give to the Minister, within such reasonable time as is

specified in the notice, such further information concerning the

application as is specified in the notice.

Applications or information may be given electronically

(5) An approval of a form mentioned in paragraph (2)(a), or a notice

mentioned in subsection (4), may require or permit an application

or information to be given in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

26C Certificates required in relation to patent infringement

proceedings

(1) This section applies if:

(a) a person gives a certificate required under subsection 26B(1)

in relation to therapeutic goods; and

(b) another person (the second person) intends to commence

proceedings under the Patents Act 1990 against the person

referred to in paragraph (1)(a) for infringement of a patent

that has been granted in relation to the therapeutic goods (the

proceedings).

(2) The second person, before the date upon which the proceedings are

commenced, must give to the Secretary and to the person referred

to in paragraph (1)(a) the certificate required by subsection (3).

(3) The certificate required by this subsection is a certificate to the

effect that the proceedings:

(a) are to be commenced in good faith; and

(b) have reasonable prospects of success; and

The certificate must be signed by, or on behalf of, the second

person and must be in a form approved by the Secretary.

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(4) For the purpose of paragraph (3)(b), proceedings have reasonable

prospects of success if:

(a) the second person had reasonable grounds in all the

circumstances known to the second person, or which ought

reasonably to have been known to the second person (in

addition to the fact of grant of the patent), for believing that

he or she would be entitled to be granted final relief by the

court against the person referred to in paragraph (1)(a) for

infringement by that person of the patent; and

(b) the second person had reasonable grounds in all the

circumstances known to the second person, or which ought

reasonably to have been known to the second person (in

addition to the fact of grant of the patent), for believing that

each of the claims, in respect of which infringement is

alleged, is valid; and

pursued.

(5) The person referred to in paragraph (1)(a), with leave of the court,

or the Attorney-General, may apply to a prescribed court for an

order that the second person pay to the Commonwealth a pecuniary

penalty if the second person gives a certificate required under

subsection (3) and:

(a) the certificate is false or misleading in a material particular;

(b) the second person breaches an undertaking given in the

certificate.

(5A) A pecuniary penalty ordered under subsection (5) must not exceed

$10,000,000.

(6) When determining the extent of a pecuniary penalty to be ordered

pursuant to subsection (5), the court must take into account:

(a) any profit obtained by the second person; and

(b) any loss or damage suffered by any person;

by reason of the second person exploiting the patent during the

proceedings.

(7) For the avoidance of doubt, subsection (6) does not limit the

matters the court may take into account when determining a

pecuniary penalty ordered pursuant to subsection (5).

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(8) If:

(a) the second person has sought and obtained in the proceedings

an interlocutory injunction restraining the person referred to

in paragraph (1)(a) from infringing a patent; and

(b) section 26D does not apply; and

certificate required under subsection (3); and

(d) a prescribed court declares that:

(i) the certificate is false or misleading in a material

particular; or

(ii) the second person has breached an undertaking given in

the certificate;

the prescribed court may, pursuant to this section, order that the

second person pay to the Commonwealth, a State or a Territory

compensation for any damages sustained or costs incurred by the

Commonwealth, a State or a Territory as a result of the grant of the

interlocutory injunction.

(9) In this section:

prescribed court has the same meaning as in the Patents Act 1990.

26D Requirements for interlocutory injunction

(1) This section applies where:

(a) an applicant gives notice to a patentee in accordance with

subparagraph 26B(1)(b)(iii); and

(b) the patentee and/or its exclusive licensee (in this section the

party or parties is or are referred to as the patentee) applies to

a prescribed court for an interlocutory injunction to restrain

the applicant from marketing the therapeutic goods the

subject of the application on the ground that such conduct

will constitute an infringement of its patent.

(2) An application for interlocutory relief in accordance with

subsection (1) may not be instituted unless the patentee has first

notified the Attorney-General of the Commonwealth, or of a State

or of a Territory, in writing of the application.

(3) The Attorney-General of the Commonwealth shall be deemed to be

a party to any proceedings commenced in accordance with

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subsection (1) unless the Attorney-General gives written notice to

the prescribed court that he or she does not desire to be a party.

(4) If an interlocutory injunction is granted pursuant to an application

made as described in subsection (1) and:

(a) the patentee subsequently discontinues the principal

proceedings without the consent of the other parties thereto;

(b) the principal proceedings are dismissed; and

(i) the patentee did not have reasonable grounds, in all the

circumstances known to the patentee or which ought

reasonably have been known to the patentee:

(A) to believe that it would be granted final relief

by the prescribed court against the applicant

referred to in paragraph (1)(a) for infringement

by that person of the patent; or

(B) (in addition to the fact of grant of the patent),

for believing that each of the claims, in respect

of which infringement is alleged in the

proceedings, would have a reasonable prospect

of being held to be valid if challenged by the

applicant referred to in paragraph (1)(a); or

(ii) the application for the interlocutory injunction was

otherwise vexatious or not reasonably made or pursued;

the prescribed court may, in addition to any other relief which it

believes should be granted to any person, make any of the orders

described in subsection (5).

(5) If the prescribed court makes a declaration pursuant to

paragraph (4)(c), the prescribed court may, pursuant to the usual

undertaking as to damages given by the patentee to the prescribed

court to obtain the interlocutory injunction:

(a) assess and award compensation to the applicant referred to in

paragraph (1)(a) against whom the interlocutory injunction

was made:

(i) on the basis of an account of the gross profits of the

patentee arising from the sale by it in Australia of the

therapeutic goods the subject of the interlocutory

injunction, during the period of the interlocutory

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injunction, without requiring the said applicant to

establish or quantify its actual loss; or

(ii) on such other basis as the court determines to be

appropriate; and

(b) award to the Commonwealth compensation for any damages

sustained, or costs incurred, by it as a result of the grant of

the interlocutory injunction; and

sustained, or costs incurred, by it as a result of the grant of

the interlocutory injunction.

(6) In this section:

prescribed court has the same meaning as in the Patents Act 1990.

27 Registration or listing number

(1) Where the Secretary includes therapeutic goods (other than

grouped therapeutic goods) in the Register, the Secretary is to

assign a unique registration or listing number to the goods.

(2) Where the Secretary includes grouped therapeutic goods in the

listing number to the grouped therapeutic goods.

28 Conditions of registration or listing

(1) The registration or listing of therapeutic goods is subject to the

conditions set out in a determination under subsection (2).

(2) The Minister may, by legislative instrument, make a determination

setting out conditions for the purposes of subsection (1), being

conditions that relate to:

(a) the manufacture of the goods; or

(b) the custody, use, supply, disposal or destruction of the goods;

(d) matters dealt with in, or matters additional to matters dealt

with in, standards applicable to the goods; or

(e) such other matters relating to the goods as the Minister thinks

appropriate.

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(2A) Without limiting subsection (2), different conditions may be

specified for:

(a) the registration of therapeutic goods; and

(b) the listing of therapeutic goods; and

(2B) If the Secretary includes therapeutic goods in the Register in

relation to a person, the Secretary may, by notice in writing given

to the person, impose conditions on the registration or listing of

those goods.

(3) The Secretary may, by notice in writing given to the person in

relation to whom therapeutic goods are registered or listed, impose

new conditions on the registration or listing or vary or remove

conditions imposed under subsection (2B) or this subsection.

(3A) The Secretary’s power under subsection (3) may be exercised at

the request of the person concerned or of the Secretary’s own

motion. A request must be accompanied by the prescribed fee.

(4) The imposition or variation or removal of a condition under

subsection (3) takes effect:

(a) if the notice states that the action is necessary to prevent

imminent risk of death, serious illness or serious injury—on

the day on which the notice is given to the person; or

(b) in any other case—on the day specified for the purpose in the

notice, being a day not earlier than 28 days after the notice is

given to the person.

(5) In addition to any conditions imposed under subsection (1), (2B) or

(3), the registration or listing of therapeutic goods (the subject

goods) is subject to the conditions that the person in relation to

whom the subject goods are registered or listed will:

(aa) not supply a batch of the subject goods in Australia, or export

a batch of the subject goods from Australia, after the expiry

date for the goods; and

(ab) not, by any means, advertise the subject goods for an

indication other than those accepted in relation to the

inclusion of the goods in the Register; and

(a) allow an authorised person:

(i) to enter, at any reasonable time, premises at which the

person deals with the subject goods; and

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(ii) while on those premises, to inspect those premises and

any therapeutic goods on those premises and to

examine, take measurements of, conduct tests on or take

samples of any therapeutic goods on those premises or

any thing on those premises that relates to any

therapeutic goods; and

(iii) while on those premises, to make any still or moving

image or any recording of those premises or any thing

on those premises; and

(b) if requested to do so by an authorised person, produce to the

person such documents relating to the subject goods as the

person requires and allow the person to copy the documents;

and

at least until the end of the period of 12 months after the

expiry date for the goods, of all of the manufacturers

involved in the manufacture of that batch; and

(d) if requested to do so by an authorised person, make any such

record available to the authorised person for inspection:

(i) at or before the time the authorised person requests, or

(if the authorised person requests) immediately; and

(ii) either in electronic form or in paper form, as the

authorised person requests; and

(e) comply, in relation to the subject goods, with any reporting

requirements that are prescribed; and

(f) if a manufacturer who was not nominated as a manufacturer

of the subject goods in the application for the registration or

listing of the goods becomes a manufacturer of the goods—

inform the Secretary in writing of that fact, no later than 10

working days after the manufacturer becomes a manufacturer

of the goods; and

(g) if premises that were not nominated as premises to be used in

the manufacture of the subject goods in the application

become premises used in the manufacture of the goods—

inform the Secretary in writing of that fact, no later than 10

working days after the premises are first used for that

purpose.

(5A) In addition to any conditions imposed under subsection (1), (2B),

(3) or (5), the listing of a medicine under section 26A is subject to

a condition that the person in relation to whom the medicine is

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listed will deliver a reasonable number of samples of the medicine

if the Secretary so requests:

(a) within the period specified in the request; and

(b) in accordance with any other requirements specified in the

request.

The period specified in the request must include at least 10

working days.

(5B) The listing of a medicine under section 26A is subject to a

condition that:

(a) each step in the manufacture of the medicine that is carried

out in Australia is carried out by a person who is the holder

of a licence to carry out that step or who is exempt from the

operation of Part 3-3 in relation to that step; and

(b) each step in the manufacture of the medicine that is carried

out outside Australia is the subject of a certification in force

under subsection 26A(3) or 28A(2).

(5C) Subsection (5B) does not apply if the medicine is exempt from the

operation of Part 3-3.

(6) If:

(a) in, or in connection with, an application for the listing of

therapeutic goods, a claim is made by the applicant in

relation to the goods; and

(b) the claim is included in the Register in respect of the goods;

the listing of the goods is subject to the following conditions:

when the claim was made, information or evidence that

supported the claim and complied with the requirements (if

any) of the regulations;

(d) a condition that the sponsor retains the information or

evidence at all times while the goods remain listed;

(e) a condition that, at any time while the goods remain listed,

the sponsor will, if asked to do so by the Secretary, give the

information or evidence to the Secretary.

(7) The regulations may prescribe the amount, standard or type of

information or evidence required for the purposes of

paragraph (6)(c).

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28A Certification of manufacturing steps outside Australia following

application for listing

(1) The person in relation to whom medicine is listed under

section 26A may apply to the Secretary for a certification under

this section of a step in the manufacture of the medicine that is to

be carried out outside Australia.

Note: The listing of medicine is subject to the condition that each step in the manufacture of the medicine that is carried out outside Australia is the subject of a certification in force under subsection 26A(3) or subsection (2) of this section: see subsection 28(5B).

(2) If an application is made to the Secretary under this section, the

Secretary may, by writing, certify that the manufacturing and

quality control procedures used in that step are acceptable. The

Secretary must give the person written notice of the certification.

(3) In deciding whether to give the certification, subsection 26A(4)

applies in a way corresponding to the way in which it applies for

the purposes of subsection 26A(3).

29 Duration of registration or listing

Where goods are included in the Register in relation to a person,

the goods remain so included until their registration or listing is

cancelled under this Part.

Note: The goods are taken not to be included in the Register while their registration or listing is suspended: see section 29G.

29A Criminal offence for failing to notify adverse effects etc. of

goods

(1) As soon as a person in relation to whom therapeutic goods are

registered or listed becomes aware of information of a kind

mentioned in subsection (2) relating to the goods, the person must

give the information to the Secretary in writing.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) The information with which subsection (1) is concerned is

information of the following kinds:

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(a) information that contradicts information already furnished by

the person under this Act;

(b) information that indicates that the use of the goods in

accordance with the recommendations for their use may have

an unintended harmful effect;

accordance with the recommendations for their use, may not

be as effective as the application for registration or listing of

the goods or information already furnished by the person

under this Act suggests;

(d) information that indicates that the quality, safety or efficacy

of the goods is unacceptable.

29AA Civil penalty for failing to notify adverse effects etc. of goods

(1) A person contravenes this section if:

(a) therapeutic goods are registered or listed in relation to a

person; and

(b) the person becomes aware of information of a kind

mentioned in subsection (2) relating to the goods; and

writing as soon as he or she becomes aware of it.

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

(2) The information with which subsection (1) is concerned is

information of the following kinds:

(a) information that contradicts information already given by the

person under this Act;

(b) information that indicates that the use of the goods in

accordance with the recommendations for their use may have

an unintended harmful effect;

accordance with the recommendations for their use, may not

be as effective as the application for registration or listing of

the goods or information already given by the person under

this Act suggests;

(d) information that indicates that the quality, safety or efficacy

of the goods is unacceptable.

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Section 29B

116 Therapeutic Goods Act 1989

29B Notification of adverse effects etc. where application withdrawn

or lapses

(1) If an application for registration or listing of goods is withdrawn or

lapses, the Secretary may give the applicant written notice

requiring the applicant:

(a) to inform the Secretary in writing whether the applicant is

aware of any information of a kind mentioned in

subsection 29A(2) or 29AA(2) relating to the goods; and

(b) if the applicant is aware of such information, to give the

information to the Secretary in writing.

(2) Notice under subsection (1) may be given within 14 days after an

application is withdrawn or lapses.

(3) A person must comply with the requirements of a notice under

subsection (1) within 30 days after the notice is given to the

person.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4) A person must not, in purported compliance with a notice under

subsection (1), give information that is false or misleading in a

material particular.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

29C Civil penalties for failing to notify adverse effects etc. where

application withdrawn or lapses

Civil penalty for failing to comply with requirements of a notice

(1) A person contravenes this subsection if the person does not comply

with the requirements of a notice under subsection 29B(1) within

30 days after the day on which the notice is given to the person.

Maximum civil penalty:

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(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

Civil penalty for giving false or misleading information in

purported compliance with requirements of a notice

(2) A person contravenes this subsection if the person, in purported

compliance with a notice under subsection 29B(1), gives

information that is false or misleading in a material particular.

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

29D Suspension of registration or listing

(1) The Secretary may, by written notice given to a person in relation

to whom therapeutic goods are included in the Register, suspend

the registration or listing of the goods if:

(a) the Secretary is satisfied that:

(i) there is a potential risk of death, serious illness or

serious injury if the therapeutic goods continue to be

included in the Register; and

(ii) it is likely that the person will, within the period of the

suspension, be able to take the action necessary to

ensure that the therapeutic goods would not cause a

potential risk of death, serious illness or serious injury if

the therapeutic goods were to continue to be included in

the Register; or

(b) the Secretary is satisfied that it is likely that there are grounds

for cancelling the registration or listing of the goods under

paragraph 30(1)(da), (e) or (f) or subsection 30(1A), (1C) or

(2).

Notice of proposed suspension in some cases

(2) However, before suspending the registration or listing of the goods

because of paragraph (1)(b), the Secretary must:

(a) inform the person by written notice that the Secretary

proposes the suspension and set out the reasons for it; and

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118 Therapeutic Goods Act 1989

(b) give the person a reasonable opportunity to make

submissions to the Secretary in relation to the proposed

suspension.

(3) The Secretary is not to make a decision relating to the proposed

suspension until the Secretary has had regard to any submissions

the person makes under paragraph (2)(b).

Period of suspension

(4) A notice under subsection (1) must specify the period of the

suspension. The period must not exceed 6 months.

Note: Section 29E deals with when the suspension takes effect and extensions of the suspension.

Publication in Gazette

(5) As soon as practicable after giving a notice under subsection (1),

the Secretary must cause to be published in the Gazette a notice

setting out particulars of the suspension.

29E When suspension takes effect etc.

(1) A suspension under section 29D takes effect:

(a) if the notice under subsection 29D(1) states that the

suspension is necessary to prevent a potential risk of death,

serious illness or serious injury—on the day on which the

notice is given to the person; or

(b) in any other case—on the day specified for the purpose in the

notice, being a day not earlier than 20 working days after the

notice is given to the person.

(2) The suspension has effect until:

(a) the Secretary revokes it under section 29F; or

(b) the end of:

(i) the period specified in the notice under

subsection 29D(4); or

(ii) if the period is extended under subsection (3) of this

section, the period as so extended.

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Therapeutic Goods Act 1989 119

Extension of suspension

(3) The Secretary may, by written notice given to the person, extend

the period specified in the notice under subsection 29D(4) by a

further specified period not exceeding 6 months.

Publication in Gazette

(4) As soon as practicable after giving a notice under subsection (3),

the Secretary must cause to be published in the Gazette a notice

setting out particulars of the extension.

29F Revocation of suspension

(1) The Secretary must revoke a suspension under section 29D, by

written notice given to the person in relation to whom the

therapeutic goods are included in the Register, if the Secretary is

satisfied that:

(a) the ground on which the registration or listing of the

therapeutic goods was suspended no longer applies; and

(b) there are no other grounds for suspending the registration or

listing of the therapeutic goods.

(2) The Secretary’s power to revoke the suspension may be exercised:

(a) if the person in relation to whom the therapeutic goods are

included in the Register applies in writing to the Secretary; or

(b) on the Secretary’s own initiative.

Publication in Gazette

(3) As soon as practicable after giving a notice under subsection (1),

the Secretary must cause to be published in the Gazette a notice

setting out particulars of the revocation.

Notice of refusal to revoke suspension

(4) If the Secretary decides, after an application is made under

paragraph (2)(a), not to revoke the suspension, the Secretary must:

(a) notify the applicant in writing of his or her decision; and

(b) state in the notice the reasons for the decision.

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Part 3-2 Registration and listing of therapeutic goods

Division 2 Registration and listing

Section 29G

120 Therapeutic Goods Act 1989

29G Effect of suspension

(1) If the registration or listing of therapeutic goods is suspended under

section 29D, the goods are taken, for the purposes of this Act

(other than sections 28, 29A, 29AA, 29E, 29F, 30 and 31), not to

be included in the Register while the suspension has effect.

Note: Dealing in therapeutic goods that are not included in the Register may be an offence or may contravene a civil penalty provision: see Division 1.

(2) While the suspension has effect, the Secretary’s power under

section 30 to cancel the registration or listing of the therapeutic

goods is not affected.

30 Cancellation of registration or listing

(1) The Secretary may, by notice in writing given to a person in

relation to whom therapeutic goods are included in the Register,

cancel the registration or listing of the goods if:

(a) it appears to the Secretary that failure to cancel the

registration or listing would create an imminent risk of death,

serious illness or serious injury; or

(b) the goods become exempt goods; or

registration or listing; or

(d) the goods contain substances that are prohibited imports for

the purposes of the Customs Act 1901; or

(da) the person has refused or failed to comply with the condition

to which the inclusion of the goods is subject under

paragraph 28(5)(d):

(i) if the person was requested under that paragraph to

make the record in question available at or before a

requested time—before the end of the period of 24

hours after that time; or

(ii) if the person was requested under that paragraph to

make the record in question available immediately—

within 24 hours after the request was made; or

(e) in the case of a medicine listed under section 26A, it appears

to the Secretary that any of the certifications under

paragraph 26A(2)(a), (ca), (cb), (e) or (g) are incorrect or (if

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Section 30

Therapeutic Goods Act 1989 121

applicable) the requirements under subsection 26A(3) or

(4A) are not fulfilled; or

(f) both of the following apply:

(i) under the regulations, an authority constituted by or

under the regulations gives a direction to, or makes a

requirement of, the person in relation to an

advertisement of the goods to ensure that advertising

complies with the Therapeutic Goods Advertising Code;

(ii) the person does not comply with the direction or

requirement.

(1A) The Secretary may, by notice in writing given to a person in

relation to whom a medicine is listed under section 26A, cancel the

listing of the medicine if:

(a) the medicine is not eligible for listing; or

(b) the medicine is exempt; or

requirements relating to advertising applicable under Part 5-1

or under the regulations, and the Secretary is satisfied that:

(i) the breach is significant; and

(ii) as a result of the breach, the presentation of the

medicine is misleading to a significant extent.

(1B) However, paragraph (1A)(c) does not apply to medicines that are

manufactured in Australia for export only, or are imported into

Australia for export only.

(1C) The Secretary may, by notice in writing given to a person in

relation to whom a medicine is listed under section 26A, cancel the

listing of the medicine if:

(a) the Secretary, under section 31, gives to the person a notice

requiring the person to give to the Secretary information or

documents relating to the medicine; and

(b) the notice is given for the purposes of ascertaining whether

the medicine should have been listed; and

days after the notice is given.

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Section 30

122 Therapeutic Goods Act 1989

(2) Subject to subsection (3), the Secretary may, by notice in writing

given to a person in relation to whom therapeutic goods are

included in the Register, cancel the registration or listing of the

goods if:

(a) it appears to the Secretary that the quality, safety or efficacy

of the goods is unacceptable; or

(b) the goods have changed so that they have become separate

and distinct from the goods as so included; or

(ba) in the case of a medicine listed under section 26A, it appears

to the Secretary that any of the certifications under

paragraph 26A(2)(b), (c), (d), (f), (fa), (fb), (fc), (h), (i), (j) or

(k) or subsection 26A(2A) are incorrect; or

to which the inclusion of the goods is subject (other than the

condition under paragraph 28(5)(d)); or

(ca) the person has contravened subsection 29A(1) or 29AA(1) in

relation to the goods; or

(d) the goods become required to be included in the other part of

the Register; or

(e) the goods do not conform to a standard applicable to the

goods or to a requirement relating to advertising applicable to

the goods under Part 5-1 or under the regulations; or

(f) the annual registration or listing charge is not paid within 28

days after it becomes payable.

(3) Where the Secretary proposes to cancel the registration or listing of

goods in relation to a person under subsection (2) otherwise than as

a result of a failure to pay the annual registration or listing charge,

the Secretary must:

(a) inform the person in writing that the Secretary proposes to

cancel that registration or listing and set out the reasons for

that proposed action; and

(b) give the person a reasonable opportunity to make

submissions to the Secretary in relation to the proposed

action.

(4) Where a person makes submissions in accordance with

paragraph (3)(b), the Secretary is not to make a decision relating to

the cancellation until the Secretary has taken the submissions into

account.

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Section 30A

Therapeutic Goods Act 1989 123

(4A) The Secretary must, by notice in writing given to a person in

relation to whom therapeutic goods are included in the Register,

cancel the registration of the goods if the Secretary becomes aware

that protected information was used when evaluating the goods for

registration.

(5) Where the Secretary cancels the registration or listing of goods in

relation to a person, the goods cease to be registered or listed:

(a) if the cancellation is effected under subsection (1), (1A) or

(1C)—on the day on which the notice of cancellation is given

to the person; or

(b) in any other case—on such later day as is specified in the

notice.

30A Revocation of cancellation of registration or listing upon

request

(1) If:

(a) the Secretary cancels the registration or listing of therapeutic

goods because of the request of a person made under

paragraph 30(1)(c); and

(b) before the end of the period of 90 days beginning on the day

the goods ceased to be registered or listed, the person

requests, in writing, the Secretary to revoke the cancellation;

and

the Secretary may, by notice in writing given to the person, revoke

the cancellation.

(2) If the cancellation is revoked, the cancellation is taken never to

have occurred.

30C Consultation with Gene Technology Regulator

(1) This section applies to an application for listing or registration of a

therapeutic good under section 23 if the therapeutic good is, or

contains, a GM product or a genetically modified organism.

(2) Subject to subsection (5), the Secretary must give written notice to

the Gene Technology Regulator:

(a) stating that the application has been made; and

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Section 30D

124 Therapeutic Goods Act 1989

(b) requesting the Gene Technology Regulator to give advice

about the application.

(3) If the Secretary gives the Gene Technology Regulator a notice

under subsection (2), the Gene Technology Regulator may give

written advice to the Secretary about the application.

(4) The advice is to be given within the period specified in the notice.

(5) If an advice from the Gene Technology Regulator is in force under

section 30D in relation to a class of therapeutic goods, the

Secretary is not required to notify the Regulator under this section

in relation to an application for listing or registration of a

therapeutic good belonging to that class.

30D Secretary may seek advice about classes of GM products or

genetically modified organisms

(1) The Secretary may request advice from the Gene Technology

Regulator in relation to:

(a) therapeutic goods that consist of, or that contain, a GM

product belonging to a class of GM products specified in the

request; or

(b) therapeutic goods that consist of, or that contain, a

genetically modified organism belonging to a class of

genetically modified organisms specified in the request.

(2) A request for advice under subsection (1) must specify the matters

to which the advice is to relate.

(3) If the Secretary requests advice from the Gene Technology

Regulator under subsection (1), the Gene Technology Regulator

may provide written advice in relation to the matters specified in

the request.

(4) If the Gene Technology Regulator gives advice to the Secretary

under subsection (3), the advice remains in force until it is

withdrawn by the Gene Technology Regulator by written notice

given to the Secretary.

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Section 30E

Therapeutic Goods Act 1989 125

30E Secretary to take advice into account

If the Secretary receives advice from the Gene Technology

Regulator:

(a) in response to a notice under section 30C within the period

specified in the notice; or

(b) under section 30D;

the Secretary must:

decision on the application to which the notice relates, or on

an application to which the advice under section 30D relates,

as the case requires; and

(d) inform the Gene Technology Regulator of the decision on the

application.

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Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2 Registration and listing of therapeutic goods

Division 2A Public notification and recovery of therapeutic goods

Section 30EA

126 Therapeutic Goods Act 1989

Division 2A—Public notification and recovery of

therapeutic goods

30EA Public notification and recovery of therapeutic goods

(1) The Secretary may, in writing, impose requirements, relating to

therapeutic goods, on a person if:

(a) any of the circumstances referred to in the second column of

an item in the following table occur in relation to the goods;

and

(b) the person is referred to in the third column of that item.

Circumstances in which requirements may be imposed

Item Circumstance relating to therapeutic goods Person subject to

requirements

1. The goods are supplied while they are

registered goods or listed goods, but they do not

conform with a standard applicable to the goods

The person in relation to

whom the goods are

included in the Register

2. The goods are supplied while they are

registered goods or listed goods, but the

manufacturing principles have not been

observed in the manufacture of the goods

The person in relation to

whom the goods are

included in the Register

3. The goods are supplied while:

(a) they are exempt goods; or

(b) they are exempt under section 18A; or

authority under section 19; or

(d) they are the subject of an approval under

section 19A;

but they do not conform with a standard

applicable to the goods

The person supplying the

goods

4. The goods are supplied while:

(a) they are exempt goods; or

(b) they are exempt under section 18A; or

authority under section 19; or

(d) they are the subject of an approval under

section 19A;

The person supplying the

goods

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Section 30EA

Therapeutic Goods Act 1989 127

Circumstances in which requirements may be imposed

Item Circumstance relating to therapeutic goods Person subject to

requirements

but the manufacturing principles have not been

observed in the manufacture of the goods

5. The goods are supplied in contravention of

subsection 19B(1), (2) or (4), 19D(1) or 42E(1)

or section 42EA

The person supplying the

goods

5A. The goods are supplied while they are

registered goods or listed goods, but it appears

to the Secretary that the quality, safety or

efficacy of the goods is unacceptable or that the

presentation of the goods is unacceptable

The person in relation to

whom the goods are

included in the Register

6. The goods are supplied while they are

registered goods or listed goods, but one or

more steps in the manufacture of the goods has

been carried out by a manufacturer while the

manufacturer did not hold a licence that was in

force

The person in relation to

whom the goods are

included in the Register

6A. The registration or listing of the goods has been

suspended under this Part

The person in relation to

whom the goods were

included in the Register

7. The registration or listing of the goods has been

cancelled under this Part

The person in relation to

whom the goods were

included in the Register

(2) The requirements may be one or more of the following:

(a) to take specified steps, in the specified manner and within

such reasonable period as is specified, to recover therapeutic

goods that have been distributed;

(b) to inform the public or a specified class of persons, in the

specified manner and within such reasonable period as is

specified, to the effect that the circumstances referred to in

paragraph (1)(a) have occurred in relation to therapeutic

goods;

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Division 2A Public notification and recovery of therapeutic goods

Section 30EB

128 Therapeutic Goods Act 1989

reasonable period as is specified, specified information, or

information of a specified kind, relating to the manufacture

or distribution of therapeutic goods.

(3) If the circumstances referred to in paragraph (1)(a) apply only to a

batch of therapeutic goods, the Secretary may limit the imposition

of the requirements to the therapeutic goods included in that batch.

(4) A requirement to recover therapeutic goods under this section does

not apply to therapeutic goods that cannot be recovered because

they have been administered to, or applied in the treatment of, a

person.

30EB Publication of requirements

The Secretary must cause to be published in the Gazette, as soon as

practicable after imposing a requirement under section 30EA, a

notice setting out particulars of the requirement.

30EC Criminal offences for non-compliance with requirements

(1) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 30EA; and

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 30EA; and

person.

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Section 30ECA

Therapeutic Goods Act 1989 129

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 30EA.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

30ECA Civil penalty for non-compliance with requirements

A person contravenes this section if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 30EA.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

30ED Powers of suspension and cancellation unaffected

Imposition of a requirement under section 30EA does not affect the

Secretary’s power to suspend or cancel the registration or listing of

therapeutic goods under this Part.

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Division 3 General

Section 30F

130 Therapeutic Goods Act 1989

Division 3—General

30F Criminal offences for goods exempt under section 18A not

conforming to standards etc.

(1) This section applies if:

(a) therapeutic goods of a particular kind are exempt under

section 18A; and

(b) a person supplies a batch of goods of that kind; and

batch:

(i) do not conform to a standard applicable to goods of that

kind; or

(ii) are otherwise not fit to be used for their intended

purposes.

(2) The Secretary may, by written notice given to the person, require

the person to take steps to recover the goods included in that batch

(except any of those goods that cannot be recovered because they

have been administered to, or applied in the treatment of, a person).

(3) The notice may specify one or more of the following requirements:

(a) the steps to be taken to recover the goods;

(b) the manner in which the steps are to be taken;

(4) The Secretary must, as soon as practicable after giving the notice,

cause particulars of it to be published in the Gazette.

Written notice is not a legislative instrument

(4A) A written notice given to a person by the Secretary under this

section is not a legislative instrument for the purposes of the

Legislative Instruments Act 2003.

Offences

(4B) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (2); and

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Therapeutic Goods Act 1989 131

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

(d) either:

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the person failed to comply with that requirement.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4C) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (2); and

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

(d) the use of the goods, if the goods were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

person failed to comply with that requirement.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4D) Subsection (4C) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(5) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (2); and

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

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Section 30FA

132 Therapeutic Goods Act 1989

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

(6) For the purposes of an offence against subsection (5), strict liability

applies to the following physical elements of circumstances:

(a) that the notice concerned is given under subsection (2);

(b) that the particular requirement concerned is a requirement

mentioned in subsection (3).

Note: For strict liability, see section 6.1 of the Criminal Code.

30FA Civil penalty for goods exempt under section 18A not

conforming to standards etc.

A person contravenes this section if:

(a) the Secretary gives a notice to the person under

subsection 30F(2); and

(b) the notice specifies a particular requirement mentioned in

subsection 30F(3); and

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

30G Disposal of unused goods exempt under section 18A

(1) This section applies to particular therapeutic goods if:

(a) an exemption in relation to those goods under section 18A

ceases to have effect otherwise than because those goods

have become registered goods or listed goods (see

paragraph 18A(5)(a)); and

(b) those goods have not been used before the exemption so

ceases to have effect.

(2) The Secretary may arrange for the disposal of any of those goods

in accordance with the regulations.

(3) Regulations made for the purposes of subsection (2) may set out

the methods by which those goods are to be stored, supplied,

destroyed, exported or otherwise disposed of.

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Section 30H

Therapeutic Goods Act 1989 133

(4) A method set out in the regulations under subsection (3) must not

enable or permit any benefit to be conferred on a person (including

the Commonwealth) other than the owner of those goods.

30H Record for goods exempt under section 18A

(1) A person commits an offence if:

(a) there are therapeutic goods that are exempt under

section 18A; and

(b) a condition of the exemption:

(i) requires the person to keep a record about those goods;

(ii) specifies the manner in which the person must keep the

record; and

those goods; and

(d) the act or omission results in the breach of that condition of

the exemption.

Penalty: 240 penalty units.

(2) Strict liability applies to paragraph (1)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

(3) A person commits an offence if:

(a) there are therapeutic goods that are exempt under

section 18A; and

(b) a condition of the exemption:

(i) requires the person to keep a record about those goods;

(ii) specifies the manner in which the person must keep the

record; and

those goods; and

(d) the act or omission results in the breach of that condition of

the exemption.

Penalty: 60 penalty units.

(4) An offence under subsection (3) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

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31 Secretary may require information

(1) The Secretary may, by notice in writing given to a person:

(aa) who is an applicant for the registration of therapeutic goods;

(ab) in relation to whom therapeutic goods are registered; or

(ac) in relation to whom therapeutic goods were, at any time

during the previous 5 years, registered;

require the person to give to the Secretary, within such reasonable

time as is specified in the notice and in such form as is specified in

the notice, information or documents relating to one or more of the

following:

(a) the formulation of the goods;

(b) the composition of the goods;

(d) the quality of the goods;

(e) the method and place of manufacture or preparation of the

goods and the procedures employed to ensure that proper

standards are maintained in the manufacture and handling of

the goods;

(f) the presentation of the goods;

(g) the safety and efficacy of the goods for the purposes for

which they are to be used;

(ga) whether the goods comply with conditions (if any) on the

registration of the goods;

(h) the conformity of the goods to a requirement relating to

advertising applicable under Part 5-1 or under the

regulations;

(ha) if the goods are registered in relation to the person—whether

the goods are being:

(i) supplied in Australia; or

(ii) imported into Australia; or

(iii) exported from Australia;

(j) the regulatory history of the goods in another country;

(k) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to goods of that kind.

(1A) If a notice is given under subsection (1) to a person covered by

paragraph (1)(ac), then paragraphs (1)(a) to (k) (to the extent to

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which they are relevant) apply in relation to that part of the period

of 5 years before the notice was given during which the therapeutic

goods were registered.

(1B) If:

(a) a person makes an application under section 23 for the

registration of therapeutic goods in accordance with a form

referred to in paragraph 23(1)(a); and

(b) the form is described as a pre-submission planning form; and

the purposes of giving information or documents to the

Secretary in the event that the person is given a notice under

subsection (1) of this section in relation to the application;

then that number of days must be specified in any such notice as

the time within which the person must give the required

information or documents to the Secretary. The number of days so

specified is taken to be a reasonable time for the purposes of

subsection (1).

(1C) If:

(a) the person in relation to whom therapeutic goods are

registered makes a request under subsection 9D(3) in

accordance with a form referred to in subsection 9D(6); and

(b) the form is described as a pre-submission planning form; and

the purposes of giving information or documents to the

Secretary in the event that the person is given a notice under

subsection (1) of this section in relation to the request;

then that number of days must be specified in any such notice as

the time within which the person must give the required

information or documents to the Secretary. The number of days so

specified is taken to be a reasonable time for the purposes of

subsection (1).

(2) The Secretary may, by notice in writing given to a person:

(aa) who is an applicant for the listing of therapeutic goods; or

(ab) in relation to whom therapeutic goods are listed; or

(ac) in relation to whom therapeutic goods were, at any time

during the previous 5 years, listed;

require the person to give to the Secretary, within such reasonable

time as is specified in the notice and in such form as is specified in

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136 Therapeutic Goods Act 1989

the notice, information or documents relating to one or more of the

following:

(a) the formulation of the goods;

(b) the composition of the goods;

(ca) the quality of the goods;

(d) the method and place of manufacture or preparation of the

goods and the procedures employed to ensure that proper

standards are maintained in the manufacture and handling of

the goods;

(e) the presentation of the goods;

(f) the safety of the goods for the purposes for which they are to

be used;

(fa) if the goods are medicine—the matters covered by a

certification by the person under paragraph 26A(2)(j) in

relation to the medicine;

(fb) whether the goods comply with conditions (if any) on the

listing of the goods;

(g) the conformity of the goods to a standard applicable to the

goods, or to a requirement relating to advertising applicable

to the goods under Part 5-1 or under the regulations;

(ga) if the goods are listed in relation to the person—whether the

goods are being:

(i) supplied in Australia; or

(ii) imported into Australia; or

(iii) exported from Australia;

(h) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to goods of that kind.

(2A) If a notice is given under subsection (2) to a person covered by

paragraph (2)(ac), then paragraphs (2)(a) to (h) (to the extent to

which they are relevant) apply in relation to that part of the period

of 5 years before the notice was given during which the therapeutic

goods were listed.

(3) An approval of a form may require or permit information to be

given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

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Section 31

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(4) A person commits an offence if:

(a) either:

(i) the person is given a notice under subsection (1) and the

person is covered by paragraph (1)(ab) or (ac); or

(ii) the person is given a notice under subsection (2) and the

person is covered by paragraph (2)(ab) or (ac); and

(b) the person fails to comply with the notice.

Penalty: 500 penalty units.

(4A) Subsection (4) does not apply if the person has a reasonable

excuse.

Note: The defendant bears an evidential burden in relation to the matter in subsection (4A). See subsection 13.3(3) of the Criminal Code.

(5) An offence under subsection (4) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(5A) A person commits an offence if:

(a) a medicine is listed under section 26A in relation to the

person; and

(b) the person provides information in purported compliance

with a notice under section 31 relating to the medicine; and

and

(d) either:

(i) the use of the medicine has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the medicine, if the medicine were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (6) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(5B) A person commits an offence if:

(a) a medicine is listed under section 26A in relation to the

person; and

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138 Therapeutic Goods Act 1989

(b) the person provides information in purported compliance

with a notice under section 31 relating to the medicine; and

and

(d) the use of the medicine, if the medicine were used, would be

likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(5C) Subsection (5B) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(6) A person in relation to whom a medicine is listed under

section 26A must not, in purported compliance with a notice under

this section relating to the medicine, provide information that is

false or misleading in a material particular.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

31AAA Civil penalty for providing false or misleading information

in relation to medicines listed under section 26A

A person contravenes this section if:

(a) a medicine is listed under section 26A in relation to the

person; and

(b) the person provides information in purported compliance

with a notice under section 31 relating to the medicine; and

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

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General Division 3

Section 31A

Therapeutic Goods Act 1989 139

31A Secretary may require information etc. about goods exempt

under section 18

Exempt goods for use for experimental purposes in humans

(1) If therapeutic goods are exempt under subsection 18(1) from the

operation of this Part (except this section and sections 31C to 31F)

to allow for their use for experimental purposes in humans, the

Secretary may give the sponsor of the goods a written notice

requiring the sponsor to give to the Secretary specified information

or documents relating to one or more of the following:

(a) the supply of the goods;

(b) the handling of the goods;

(d) the results of the supply of the goods;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to goods of that kind.

Statement by medical practitioner about medicine

(2) If a medicine is exempt under subsection 18(1) from the operation

of this Part (except this section and sections 31C to 31F) because a

medical practitioner has signed a statement in accordance with

regulation 12A of the Therapeutic Goods Regulations 1990, the

Secretary may give the medical practitioner a written notice

requiring the medical practitioner to give to the Secretary specified

information or documents relating to one or more of the following:

(a) the condition of the person to whom the medicine is to be

given or is given;

(b) the supply of the medicine;

(d) the monitoring of the supply of the medicine;

(e) the results of the supply of the medicine;

(f) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to medicines of that

kind.

Compliance period

(3) A notice under subsection (1) or (2) must specify a reasonable

period within which the person to whom the notice is given must

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comply with it. The period must be at least 14 days starting on the

day on which the notice is given.

Information may need to be given in accordance with specified

software requirements

(4) A notice under subsection (1) or (2) may require information to be

given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

31AA Secretary may require information etc. about goods exempt

under section 18A

(1) This section applies to a person who is required to comply with a

condition of an exemption of therapeutic goods under section 18A.

(2) The Secretary may, by written notice given to the person, require

the person to give to the Secretary specified information or

documents relating to one or more of the following:

(a) the supply of any of those goods;

(b) the handling of any of those goods;

(d) the results of the supply of any of those goods;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph.

Compliance period

(3) The notice must specify a reasonable period within which the

person must comply with it. The period must be at least 14 days

starting on the day on which the notice is given.

Information may need to be given in accordance with specified

software requirements

(4) The notice may require information to be given in accordance with

specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

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General Division 3

Section 31B

Therapeutic Goods Act 1989 141

31B Secretary may require information relating to approvals and

authorities under section 19

Approval under subsection 19(1)

(1) The Secretary may give to a person who is granted an approval

under subsection 19(1) in relation to specified therapeutic goods a

written notice requiring the person to give to the Secretary

specified information or documents relating to one or more of the

following:

(a) the supply of the goods;

(b) the handling of the goods;

(d) the results of the supply of the goods;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to goods of that kind.

Approval under subsection 19(1)—use by another person

(2) The Secretary may give to a person using specified therapeutic

goods that are the subject of an approval granted to someone else

under paragraph 19(1)(b) a written notice requiring the person to

give to the Secretary specified information or documents relating

to either of both of the following:

(a) the use of the goods;

(b) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to goods of that kind.

Authority under subsection 19(5)

(3) The Secretary may give to a person who is granted an authority

under subsection 19(5) in relation to specified therapeutic goods, or

a specified class of therapeutic goods, a written notice requiring the

person to give to the Secretary specified information or documents

relating to one or more of the following:

(a) the supply of the goods;

(b) the handling of the goods;

(d) the results of the supply of the goods;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to goods of that kind.

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Part 3-2 Registration and listing of therapeutic goods

Division 3 General

Section 31C

142 Therapeutic Goods Act 1989

Compliance period

(4) A notice under subsection (1), (2) or (3) must specify a reasonable

period within which the person to whom the notice is given must

comply with it. The period must be at least 14 days starting on the

day on which the notice is given.

Information may need to be given in accordance with specified

software requirements

(5) A notice under subsection (1), (2) or (3) may require information to

be given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

31C Criminal offence for failing to give information or documents

sought under section 31A, 31AA or 31B

A person commits an offence if:

(a) the person is given a notice under section 31A, 31AA or 31B;

and

(b) the person fails to comply with the notice.

Penalty: 400 penalty units.

Note: The privilege against self incrimination is not a reasonable excuse for the purposes of this section. However, the information given, and the fact that a document was given under this section (and other information, documents or things obtained because of giving the information or document) generally cannot be used in a prosecution (see section 31F).

31D False or misleading information

(1) A person to whom a notice is given under section 31A, 31AA or

31B is guilty of an offence if:

(a) the person gives information to the Secretary in compliance

or purported compliance with the notice; and

(b) the person does so knowing that the information:

(i) is false or misleading; or

(ii) omits any matter or thing without which the information

is misleading.

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Section 31E

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Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Subsection (1) does not apply as a result of subparagraph (1)(b)(i)

if the information is not false or misleading in a material particular.

Note: A defendant bears an evidential burden in relation to the matter in subsection (2).

(3) Subsection (1) does not apply as a result of subparagraph (1)(b)(ii)

if the information did not omit any matter or thing without which

the information is misleading in a material particular.

Note: A defendant bears an evidential burden in relation to the matter in subsection (3).

31E False or misleading documents

(1) A person is guilty of an offence if:

(a) the person produces a document to the Secretary; and

(b) the person does so knowing that the document is false or

misleading; and

compliance with a notice given under section 31A, 31AA or

31B.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Subsection (1) does not apply if the document is not false or

misleading in a material particular.

Note: A defendant bears an evidential burden in relation to the matter in subsection (2).

(3) Subsection (1) does not apply to a person who produces a

document if the document is accompanied by a written statement

signed by the person or, in the case of a body corporate, by a

competent officer of the body corporate:

(a) stating that the document is, to the knowledge of the

first-mentioned person, false or misleading in a material

particular; and

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(b) setting out, or referring to, the material particular in which

the document is, to the knowledge of the first-mentioned

person, false or misleading.

Note: A defendant bears an evidential burden in relation to the matter in subsection (3).

31F Self-incrimination

(1) A person is not excused from giving information or a document

under a notice given under section 31A, 31AA or 31B on the

ground that the giving of the information or document would tend

to incriminate the person or expose the person to a penalty.

(2) However, in the case of an individual:

(a) the information given; or

(b) the giving of the document; or

indirect consequence of giving the information or document;

is not admissible in evidence in:

(d) criminal proceedings against the individual, except

proceedings under, or arising out of, section 31D or 31E; or

(e) proceedings for a pecuniary penalty order against the

individual for a contravention of a civil penalty provision.

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Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Preliminary Division 1

Section 32

Therapeutic Goods Act 1989 145

Part 3-2A—Biologicals

Division 1—Preliminary

32 What this Part is about

This Part regulates biologicals. It does this by providing a process

for including biologicals in the Register and providing for

enforcement through criminal offences and civil penalties.

This Part provides for the following administrative processes:

(a) exempting biologicals from the requirement to be

included in the Register;

(b) making the inclusion of biologicals in the Register

subject to conditions;

from the Register;

(d) requiring public notification of problems with

biologicals, and recovery of biologicals;

(e) obtaining information or documents about

biologicals.

32A Meaning of biological

(1) Subject to subsection (3), a biological is a thing that:

(a) either:

(i) comprises, contains or is derived from human cells or

human tissues; or

(ii) is specified under subsection (2); and

(b) is represented in any way to be, or is, whether because of the

way in which it is presented or for any other reason, likely to

be taken to be:

(i) for use in the treatment or prevention of a disease,

ailment, defect or injury affecting persons; or

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Division 1 Preliminary

Section 32AA

146 Therapeutic Goods Act 1989

(ii) for use in making a medical diagnosis of the condition

of a person; or

(iii) for use in influencing, inhibiting or modifying a

physiological process in persons; or

(iv) for use in testing the susceptibility of persons to a

disease or ailment; or

(v) for use in the replacement or modification of parts of the

anatomy in persons.

(2) The Secretary may, by legislative instrument, specify things for the

purposes of subparagraph (1)(a)(ii).

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

(3) The Secretary may, by legislative instrument, determine that a

specified thing is not a biological for the purposes of this Act.

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

32AA Biological classes

The regulations may prescribe different classes of biologicals.

Note 1: The regulations may prescribe the circumstances in which a biological included in a class of biologicals is separate and distinct from other biologicals: see section 32AB.

Note 2: The Secretary may approve different application forms for different classes of biologicals: see section 32DD.

32AB When biologicals are separate and distinct from other

biologicals

(1) The regulations may prescribe the circumstances in which a

biological included in a specified class of biologicals is separate

and distinct from other biologicals.

(2) The regulations may make different provision in relation to

different classes of biologicals that are prescribed by the

regulations for the purposes of section 32AA.

Note: The Secretary may cancel the entry of a biological from the Register if the biological has changed so that it has become separate and distinct from the biological as so included: see subsection 32GC(1).

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Biologicals Part 3-2A

Main criminal offences and civil penalties Division 2

Section 32B

Therapeutic Goods Act 1989 147

Division 2—Main criminal offences and civil penalties

32B What this Division is about

This Division contains criminal offences and civil penalties

relating to the import, export, manufacture, supply and use of

biologicals.

32BA Criminal offences for importing a biological

(1) A person commits an offence if:

(a) the person imports into Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the importation into Australia of the

biological;

(v) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person;

and

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

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Part 3-2A Biologicals

Division 2 Main criminal offences and civil penalties

Section 32BA

148 Therapeutic Goods Act 1989

(2) A person commits an offence if:

(a) the person imports into Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the importation into Australia of the

biological;

(v) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person;

and

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) An offence against subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person imports into Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

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Main criminal offences and civil penalties Division 2

Section 32BB

Therapeutic Goods Act 1989 149

approval covering the importation into Australia of the

biological;

(v) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Defences

(5) Subsection (1), (2) or (4) does not apply if the defendant proves

that the defendant was not the sponsor of the biological at the time

of the importation.

Note: A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

(6) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological; or

(b) harm or injury would not directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological.

Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

32BB Criminal offences for exporting a biological

(1) A person commits an offence if:

(a) the person exports from Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

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Part 3-2A Biologicals

Division 2 Main criminal offences and civil penalties

Section 32BB

150 Therapeutic Goods Act 1989

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the exportation from Australia of the

biological; and

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person exports from Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the exportation from Australia of the

biological; and

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) An offence against subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

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Biologicals Part 3-2A

Main criminal offences and civil penalties Division 2

Section 32BB

Therapeutic Goods Act 1989 151

(4) A person commits an offence if:

(a) the person exports from Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the exportation from Australia of the

biological.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Defences

(5) Subsection (1), (2) or (4) does not apply if the defendant proves

that the defendant was not the sponsor of the biological at the time

of the exportation.

Note: A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

(6) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological; or

(b) harm or injury would not directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological.

Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

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Part 3-2A Biologicals

Division 2 Main criminal offences and civil penalties

Section 32BC

152 Therapeutic Goods Act 1989

32BC Criminal offences for manufacturing a biological

(1) A person commits an offence if:

(a) the person manufactures in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB; and

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person manufactures in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB; and

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

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(3) An offence against subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person manufactures in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Defences

(5) Subsection (1), (2) or (4) does not apply if the defendant proves

that the defendant was not the sponsor of the biological at the time

of the manufacture.

Note: A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

(6) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological; or

(b) harm or injury would not directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological.

Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

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Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 2 Main criminal offences and civil penalties

Section 32BD

154 Therapeutic Goods Act 1989

32BD Criminal offences for supplying a biological

(1) A person commits an offence if:

(a) the person supplies in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological; and

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person supplies in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

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Section 32BD

Therapeutic Goods Act 1989 155

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological; and

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) An offence against subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person supplies in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

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Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 2 Main criminal offences and civil penalties

Section 32BE

156 Therapeutic Goods Act 1989

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Defences

(5) Subsection (1), (2) or (4) does not apply if the defendant proves

that the defendant was not the sponsor of the biological at the time

of the supply.

Note: A defendant bears a legal burden in relation to the matter in subsection (5): see section 13.4 of the Criminal Code.

(6) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological; or

(b) harm or injury would not directly result from:

(i) the quality, safety or efficacy of the biological; or

(ii) a matter relating to the labelling or packaging of the

biological; or

(iii) the improper use of the biological.

Note: A defendant bears an evidential burden in relation to the matters in subsection (6): see subsection 13.3(3) of the Criminal Code.

32BE Notice required to adduce evidence in support of exception to

offences

(1) If:

(a) a defendant is committed for trial for an offence against

subsection 32BA(1), 32BB(1), 32BC(1) or 32BD(1); or

(b) an offence against subsection 32BA(1), 32BB(1), 32BC(1) or

32BD(1) is to be heard and determined by a court of

summary jurisdiction;

the committing magistrate or the court must:

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Section 32BE

Therapeutic Goods Act 1989 157

(d) cause a copy of this section to be given to the defendant.

(2) A defendant must not, without leave of the court, adduce evidence

in support of the exception under subsection 32BA(6), 32BB(6),

32BC(6) or 32BD(6) unless the defendant gives notice of

particulars of the exception:

(a) if paragraph (1)(a) applies—more than 21 days before the

trial begins; or

(b) if paragraph (1)(b) applies—more than 21 days before the

hearing of the offence begins.

(3) A defendant must not, without leave of the court, call any other

person to give evidence in support of the exception unless:

(a) the notice under subsection (2) includes the name and

address of the person or, if the name and address is not

known to the defendant at the time the defendant gives the

notice, any information in the defendant’s possession that

might be of material assistance in finding the person; and

(b) if the name or the address is not included in the notice—the

court is satisfied that the defendant before giving the notice

took, and after giving the notice continued to take, all

reasonable steps to ascertain the name or address; and

defendant subsequently ascertains the name or address or

receives information that might be of material assistance in

finding the person—the defendant immediately gives notice

of the name, address or other information, as the case may

be; and

(d) if the defendant is told by or on behalf of the prosecutor that

the person has not been found by the name, or at the address,

given by the defendant:

(i) the defendant immediately gives notice of any

information in the defendant’s possession that might be

of material assistance in finding the person; and

(ii) if the defendant later receives any such information—

the defendant immediately gives notice of the

information.

(4) A notice purporting to be given under this section on behalf of the

defendant by the defendant’s legal practitioner is, unless the

contrary is proved, taken as having been given with the authority of

the defendant.

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Part 3-2A Biologicals

Division 2 Main criminal offences and civil penalties

Section 32BF

158 Therapeutic Goods Act 1989

(5) Any evidence tendered to disprove that the exception applies may,

subject to direction by the court, be given before or after evidence

is given in support of the exception.

(6) A notice under this section must be given in writing to the Director

of Public Prosecutions. A notice is taken as having been given if it

is:

(a) delivered to or left at an office of the Office of the Director

of Public Prosecutions; or

(b) sent by certified mail addressed to the Director of Public

Prosecutions at an office of the Office of the Director of

Public Prosecutions.

(7) In this section:

Director of Public Prosecutions means a person holding office as,

or acting as, the Director of Public Prosecutions under the Director

of Public Prosecutions Act 1983.

32BF Civil penalties for importing, exporting, manufacturing or

supplying a biological

Importing a biological for use in humans

(1) A person contravenes this subsection if:

(a) the person imports into Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the importation into Australia of the

biological;

(v) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person.

Maximum civil penalty:

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Section 32BF

Therapeutic Goods Act 1989 159

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Exporting a biological for use in humans

(2) A person contravenes this subsection if:

(a) the person exports from Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the exportation from Australia of the

biological.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Manufacturing a biological for use in humans

(3) A person contravenes this subsection if:

(a) the person manufactures in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

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Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 2 Main criminal offences and civil penalties

Section 32BF

160 Therapeutic Goods Act 1989

Supplying a biological for use in humans

(4) A person contravenes this subsection if:

(a) the person supplies in Australia a biological for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Exception if person was not the sponsor of the biological

(5) Subsection (1), (2), (3) or (4) does not apply if the person proves

that he or she was not the sponsor of the biological at the time of

the importation, exportation, manufacture or supply, as the case

may be.

Civil penalty relating to the supply of biologicals included in the

Register

(6) A person contravenes this subsection if:

(a) a biological is included in the Register in relation to the

person; and

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Section 32BG

Therapeutic Goods Act 1989 161

(b) the biological is of a kind prescribed by the regulations for

the purposes of this paragraph; and

(d) the biological number of the biological is not set out on the

label of the biological in the prescribed manner.

Maximum civil penalty:

(a) for an individual—200 penalty units; and

(b) for a body corporate—2,000 penalty units.

32BG Criminal offence and civil penalty relating to a failure to

notify the Secretary about manufacturing

Criminal offence

(1) A person commits an offence if:

(a) the person:

(i) imports a biological into Australia for use in humans; or

(ii) exports a biological from Australia for use in humans;

(iii) manufactures a biological in Australia for use in

humans; or

(iv) supplies a biological in Australia for use in humans; and

(b) the person is the sponsor of the biological; and

relation to the biological and the biological is not exempt

under subsection 32CA(2); and

(d) the person has not, at or before the time of the importation,

exportation, manufacture or supply, properly notified to the

Secretary either or both of the following:

(i) the manufacturer of the biological;

(ii) the premises used in the manufacture of the biological.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Civil penalty

(2) A person contravenes this subsection if:

(a) the person:

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Section 32BG

162 Therapeutic Goods Act 1989

(i) imports a biological into Australia for use in humans; or

(ii) exports a biological from Australia for use in humans;

(iii) manufactures a biological in Australia for use in

humans; or

(iv) supplies a biological in Australia for use in humans; and

(b) the person is the sponsor of the biological; and

relation to the biological and the biological is not exempt

under subsection 32CA(2); and

(d) the person has not, at or before the time of the importation,

exportation, manufacture or supply, properly notified to the

Secretary either or both of the following:

(i) the manufacturer of the biological;

(ii) the premises used in the manufacture of the biological.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Definition

(3) For the purposes of this section:

(a) a manufacturer is properly notified to the Secretary if:

(i) the manufacturer was nominated, as a manufacturer of

the biological, in an application for inclusion of the

biological in the Register; or

(ii) the Secretary was subsequently informed in writing that

the manufacturer is a manufacturer of the biological;

and

(b) premises are properly notified to the Secretary if:

(i) the premises were nominated, as premises used in the

manufacture of the biological, in an application for

inclusion of the biological in the Register; or

(ii) the Secretary was subsequently informed in writing that

the premises are used in the manufacture of the

biological.

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Section 32BH

Therapeutic Goods Act 1989 163

32BH Criminal offence relating to wholesale supply

A person commits an offence if:

(a) the person supplies a biological in Australia for use in

humans; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological; and

ultimate consumer of the biological.

Penalty: 120 penalty units.

32BI Criminal offence for using a biological not included in the

Register

(1) A person commits an offence if:

(a) the person uses a biological; and

(b) the biological is used:

(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans; and

(i) the biological is included in the Register;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

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Division 2 Main criminal offences and civil penalties

Section 32BI

164 Therapeutic Goods Act 1989

(iv) the biological is the subject of an approval under

subsection 32CO(1) or (2);

(v) the person uses the biological in accordance with an

approval under subsection 32CK(1);

(vi) the person uses the biological in accordance with a

condition applicable under regulations made for the

purposes of section 32CL;

(vii) the person uses the biological in accordance with an

authority under subsection 32CM(1); and

(d) either:

(i) if the person used the biological in the treatment of that

other person—the use of the biological has resulted in,

or will result in, harm or injury to that other person; or

(ii) if the person used the biological solely for experimental

purposes in humans—the use of the biological has

resulted in, or will result in, harm or injury to any of

those humans.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

(2) A person commits an offence if:

(a) the person uses a biological; and

(b) the biological is used:

(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans; and

(i) the biological is included in the Register;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CO(1) or (2);

(v) the person uses the biological in accordance with an

approval under subsection 32CK(1);

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Section 32BI

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(vi) the person uses the biological in accordance with a

condition applicable under regulations made for the

purposes of section 32CL;

(vii) the person uses the biological in accordance with an

authority under subsection 32CM(1); and

(d) either:

(i) if the person used the biological in the treatment of

another person—the use of the biological is likely to

result in harm or injury to that other person; or

(ii) if the person used the biological solely for experimental

purposes in humans—the use of the biological is likely

to result in harm or injury to any of those humans.

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person uses a biological; and

(b) the biological is used:

(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans; and

(i) the biological is included in the Register;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

(iv) the biological is the subject of an approval under

subsection 32CO(1) or (2);

(v) the person uses the biological in accordance with an

approval under subsection 32CK(1);

(vi) the person uses the biological in accordance with a

condition applicable under regulations made for the

purposes of section 32CL;

(vii) the person uses the biological in accordance with an

authority under subsection 32CM(1).

Penalty for contravention of this subsection:500 penalty units.

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Part 3-2A Biologicals

Division 2 Main criminal offences and civil penalties

Section 32BJ

166 Therapeutic Goods Act 1989

32BJ General criminal offences relating to this Part

Including incorrect biological number on containers etc.

(1) A person commits an offence if:

(a) the person sets out or causes to be set out, on a container or

package that contains a biological or on a label of a

biological, a number that purports to be the biological

number of the biological; and

(b) the number is not that biological number.

Penalty: 60 penalty units.

(2) For the purposes of subsection (1), number includes any

combination of one or more of the following:

(a) numbers;

(b) letters;

Advertising biological for an indication

(3) A person commits an offence if:

(a) the person, by any means, advertises a biological for an

indication; and

(b) the biological is included in the Register; and

inclusion.

Penalty: 60 penalty units.

Arranging supply of biological not included in Register

(4) A person commits an offence if:

(a) the person claims, by any means, that the person or another

person can arrange the supply of a biological; and

(b) none of the following subparagraphs applies:

(i) the biological is included in the Register in relation to

the person;

(ii) the person is exempt under subsection 32CA(1) in

relation to the biological or the biological is exempt

under subsection 32CA(2);

(iii) the biological is exempt under section 32CB;

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Section 32BK

Therapeutic Goods Act 1989 167

(iv) the biological is the subject of an approval under

subsection 32CK(1) that is held by the person, being an

approval covering the supply in Australia of the

biological;

(v) the biological is the subject of an authority under

subsection 32CM(1) that is held by the person;

(vi) the biological is the subject of an approval under

subsection 32CO(1) or (2) that is held by the person,

being an approval covering the supply in Australia of

the biological.

Penalty for contravention of this subsection:60 penalty units.

32BK Civil penalty for making misrepresentations about biologicals

(1) A person contravenes this section if:

(a) the person makes a representation of a kind referred to in

subsection (2); and

(b) the representation is false or misleading.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

(2) Subsection (1) applies to the following representations:

(a) representations that a biological is included in the Register;

(b) representations that a person is exempt under

subsection 32CA(1) in relation to a biological or that a

biological is exempt under subsection 32CA(2);

section 32CB;

(d) representations that a biological is the subject of an approval

under subsection 32CK(1);

(e) representations that a biological is the subject of an authority

under subsection 32CM(1);

(f) representations that a biological is the subject of an approval

under subsection 32CO(1) or (2).

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Part 3-2A Biologicals

Division 3 Exemptions

Section 32C

168 Therapeutic Goods Act 1989

Division 3—Exemptions

Subdivision A—Preliminary

32C What this Division is about

There are 4 kinds of exemptions in relation to biologicals:

(a) exemptions of biologicals under the regulations;

and

(b) exemptions of biologicals to deal with

emergencies; and

experimental uses; and

(d) exemptions of biologicals where substitutes are

unavailable.

Subdivision B—Exempting biologicals under the regulations

32CA Exempt biologicals

(1) The regulations may exempt specified persons from the operation

of Division 4 in relation to specified biologicals.

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

(2) The regulations may exempt specified biologicals from the

operation of Division 4.

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

(3) An exemption under this section may be subject to conditions that

are prescribed in the regulations.

(4) A person commits an offence if:

(a) the person does an act or omits to do an act; and

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Section 32CB

Therapeutic Goods Act 1989 169

(b) the act or omission results in the breach of a condition of an

exemption under this section.

Penalty: 60 penalty units.

(5) If the regulations revoke an exemption, the revocation takes effect

on the day specified in the regulations. The day must not be earlier

than 28 days after the day on which the regulations revoking the

exemption take effect.

Subdivision C—Exempting biologicals to deal with emergencies

32CB Minister may make exemptions

(1) The Minister may, by writing, exempt specified biologicals from

the operation of Division 4.

Note 1: For specification by class, see subsection 33(3AB) of the Acts Interpretation Act 1901.

Note 2: There are criminal offences and a civil penalty relating to biologicals exempt under this section not conforming to standards etc.: see section 32CJ.

(2) The Minister may make an exemption under subsection (1) only if

the Minister is satisfied that, in the national interest, the exemption

should be made so that:

(a) the biologicals may be stockpiled as quickly as possible in

order to create a preparedness to deal with a potential threat

to public health that may be caused by a possible future

emergency; or

(b) the biologicals can be made available urgently in Australia in

order to deal with an actual threat to public health caused by

an emergency that has occurred.

Period of exemption

(3) An exemption under subsection (1) comes into force:

(a) on the day the exemption is made; or

(b) on a later day specified in the exemption.

(4) An exemption under subsection (1) remains in force for the period

specified in the exemption, unless revoked earlier.

Note: Section 32CD deals with variation and revocation of the exemption.

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Part 3-2A Biologicals

Division 3 Exemptions

Section 32CC

170 Therapeutic Goods Act 1989

Effect of inclusion of biological in the Register

(5) An exemption under subsection (1) ceases to have effect in relation

to a particular biological when that biological becomes included in

the Register under Division 4.

Exemption not a legislative instrument

(6) An exemption under subsection (1) is not a legislative instrument.

32CC Conditions of exemptions

An exemption under section 32CB is subject to conditions

specified in the exemption about any of the following:

(a) the quantity of biologicals that are exempt;

(b) the source of those biologicals;

manufacture or supply those biologicals;

(d) the supply of those biologicals (including the persons or class

of persons to whom biologicals may be supplied for use and

the circumstances under which a stockpile of biologicals may

be supplied for use);

(e) the storage and security of those biologicals;

(f) the keeping and disclosure of, and access to, records about

those biologicals;

(g) the disposal of those biologicals;

(h) the manner in which any of those biologicals is to be dealt

with if a condition of the exemption is breached;

(i) any other matters that the Minister thinks appropriate.

Whether or not biologicals are exempt under section 32CB is not

affected by whether or not there is a breach of a condition under

this section in relation to those biologicals.

Note 1: There are criminal offences and civil penalties related to the breach of a condition of an exemption: see sections 32CH and 32CI.

Note 2: Section 32CD deals with variation and revocation of the conditions.

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Section 32CD

Therapeutic Goods Act 1989 171

32CD Variation or revocation of exemption

Variation of exemption

(1) The Minister may, by writing, vary an exemption made under

section 32CB by removing specified biologicals from the

exemption.

Note: For specification by class, see subsection 33(3AB) of the Acts Interpretation Act 1901.

Revocation of exemption

(2) The Minister may, by writing, revoke an exemption made under

section 32CB.

Variation or revocation of conditions

(3) The Minister may, by writing:

(a) vary the conditions of an exemption made under

section 32CB (including by imposing new conditions); or

(b) revoke the conditions of an exemption made under

section 32CB.

When variation or revocation takes effect

(4) A variation or revocation under this section takes effect:

(a) if the Minister states in the variation or revocation that the

variation or revocation is necessary to prevent imminent risk

of death, serious illness or serious injury—on the day the

variation or revocation is made; or

(b) in any other case—on a later day specified in the variation or

revocation (which must not be earlier than 28 days after the

day the variation or revocation is made).

32CE Informing persons of exemption etc.

If the Minister makes an exemption under section 32CB, the

Minister must take reasonable steps to give a copy of the following

to each person covered by paragraph 32CC(c):

(a) the exemption;

(b) any variation or revocation of the exemption under

section 32CD.

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Part 3-2A Biologicals

Division 3 Exemptions

Section 32CF

172 Therapeutic Goods Act 1989

32CF Notification and tabling

Notification

(1) The Secretary must cause a notice setting out particulars of the

following:

(a) an exemption made under section 32CB because of

paragraph 32CB(2)(b);

(b) a variation or revocation under section 32CD, to the extent

that the variation or revocation relates to an exemption made

under section 32CB because of paragraph 32CB(2)(b);

to be published in the Gazette within 7 days after the day on which

the exemption, variation or revocation is made. However, the

exemption, variation or revocation is not invalid merely because of

a failure to comply with this subsection.

Tabling

(2) The Minister must cause a document setting out particulars of the

following:

(a) an exemption made under section 32CB because of

paragraph 32CB(2)(b);

(b) a variation or revocation under section 32CD, to the extent

that the variation or revocation relates to an exemption made

under section 32CB because of paragraph 32CB(2)(b);

to be tabled in each House of the Parliament within 5 sitting days

of that House after the day on which the exemption, variation or

revocation is made. However, the exemption, variation or

revocation is not invalid merely because of a failure to comply

with this subsection.

32CG Disposal of unused biologicals

(1) This section applies to a biological if:

(a) an exemption under section 32CB in relation to that

biological ceases to have effect otherwise than because that

biological becomes included in the Register under

Division 4; and

(b) that biological has not been used before the exemption so

ceases to have effect.

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Exemptions Division 3

Section 32CH

Therapeutic Goods Act 1989 173

(2) The Secretary may arrange for the disposal of the biological in

accordance with the regulations.

(3) Regulations made for the purposes of subsection (2) may set out

the methods by which the biological is to be stored, supplied,

destroyed, exported or otherwise disposed of.

(4) A method set out in the regulations under subsection (3) must not

enable or permit any benefit to be conferred on a person (including

the Commonwealth) other than the owner of the biological.

32CH Criminal offences for breaching a condition of an exemption

(1) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to a

biological; and

(b) the biological is covered by an exemption in force under

section 32CB; and

exemption; and

(d) the act or omission is likely to cause a serious risk to public

health.

Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Strict liability applies to paragraph (1)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

(3) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to a

biological; and

(b) the biological is covered by an exemption in force under

section 32CB; and

exemption.

Penalty: Imprisonment for 4 years or 240 penalty units, or both.

(4) Strict liability applies to paragraph (3)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

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Section 32CI

174 Therapeutic Goods Act 1989

(5) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to a

biological; and

(b) the biological is covered by an exemption in force under

section 32CB; and

exemption.

Penalty: 60 penalty units.

(6) An offence against subsection (5) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

32CI Civil penalty for breaching a condition of an exemption

A person contravenes this section if:

(a) the person does an act or omits to do an act in relation to a

biological; and

(b) the biological is covered by an exemption in force under

section 32CB; and

exemption.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

32CJ Criminal offences and civil penalty for biologicals not

conforming to standards etc.

(1) This section applies if:

(a) a biological is exempt under section 32CB; and

(b) a person supplies a batch of the biologicals; and

batch:

(i) do not conform to a standard applicable to the

biologicals; or

(ii) are otherwise not fit to be used for their intended

purposes.

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Section 32CJ

Therapeutic Goods Act 1989 175

(2) The Secretary may, by written notice given to the person, require

the person to take steps to recover the biologicals included in that

batch (except any of those biologicals that cannot be recovered

because they have been administered to, or applied in the treatment

of, a person).

(3) The notice may specify one or more of the following requirements:

(a) the steps to be taken to recover the biologicals;

(b) the manner in which the steps are to be taken;

(4) The Secretary must, as soon as practicable after giving the notice,

cause particulars of it to be published in the Gazette.

Notice is not a legislative instrument

(5) A notice given under subsection (2) is not a legislative instrument.

Offences

(6) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (2); and

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

(d) either:

(i) the use of any of the biologicals has resulted in, or will

result in, harm or injury to any person; or

(ii) the use of any of the biologicals, if any of the

biologicals were used, would result in harm or injury to

any person; and

(e) the harm or injury has resulted, will result, or would result,

because the person failed to comply with that requirement.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(7) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (2); and

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Section 32CJ

176 Therapeutic Goods Act 1989

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

(d) the use of any of the biologicals, if any of the biologicals

were used, would be likely to result in harm or injury to any

person; and

(e) the harm or injury would be likely to result because the

person failed to comply with that requirement.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(8) An offence against subsection (7) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(9) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (2); and

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

Penalty: 60 penalty units.

(10) An offence against subsection (9) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

Civil penalty

(11) A person contravenes this subsection if:

(a) the Secretary gives a notice to the person under

subsection (2); and

(b) the notice specifies a particular requirement mentioned in

subsection (3); and

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

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Exemptions Division 3

Section 32CK

Therapeutic Goods Act 1989 177

Subdivision D—Exempting biologicals for special and

experimental uses

32CK Approvals for importing, exporting or supplying a biological

for special and experimental uses

(1) The Secretary may, by notice in writing, grant an approval to a

person for one or more of the following:

(a) the importation into Australia of a specified biological;

(b) the exportation from Australia of a specified biological;

that is:

(d) for use in the treatment of another person; or

(e) for use solely for experimental purposes in humans.

(2) Subsection (1) does not apply if the biological is included in the

relation to the biological or the biological is exempt under

subsection 32CA(2).

Application for approval

(3) An application for an approval for use of the kind referred to in

paragraph (1)(d) must:

(a) be made to the Secretary; and

(b) be accompanied by such information relating to the

biological the subject of the application as is required by the

Secretary.

(4) An application for an approval for use of the kind referred to in

paragraph (1)(e) must:

(a) be made to the Secretary; and

(b) be made in writing; and

biological the subject of the application as is required by the

Secretary; and

(d) be accompanied by the prescribed evaluation fee.

Secretary’s decision

(5) If an application for an approval is made, the Secretary must:

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Section 32CL

178 Therapeutic Goods Act 1989

(a) after having considered the application; and

(b) in the case of an application for an approval for use of the

kind referred to in paragraph (1)(e)—after having evaluated

the information submitted with the application;

notify the applicant of the decision on the application as soon as

practicable after making the decision and, in the case of a decision

not to grant the approval, of the reasons for the decision.

Conditions

(6) The Secretary may grant an approval under subsection (1) subject

to any conditions that are specified in the notice of approval.

(7) Those conditions may include a condition relating to the charges

that may be made for the biological to which the approval relates.

This subsection does not limit subsection (6).

(8) An approval under subsection (1) for use of the kind referred to in

paragraph (1)(e) is subject to the conditions (if any) specified in the

regulations. Those conditions (if any) are in addition to any

conditions imposed under subsection (6).

(9) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission results in the breach of a condition of an

approval under subsection (1).

Penalty: 60 penalty units.

Approval not a legislative instrument

(10) An approval under subsection (1) is not a legislative instrument.

32CL Conditions of use of biological for experimental purposes in

humans

(1) The use by a person (the experimenter) for experimental purposes

in humans of a biological that is the subject of an approval:

(a) that is held by another person under subsection 32CK(1); and

(b) that covers the importation into Australia, or the supply in

Australia, of the biological for use solely for experimental

purposes in humans;

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Section 32CM

Therapeutic Goods Act 1989 179

is subject to the conditions (if any) specified in the regulations

relating to one or more of the following:

purposes;

(d) the principles to be followed in the use of the biological for

those purposes;

(e) the monitoring of the use, and the results of the use, of the

biological for those purposes;

(f) the circumstances in which the experimenter must cease the

use of the biological for those purposes.

(2) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission results in the breach of a condition

applicable under regulations made for the purposes of this

section.

Penalty for contravention of this subsection:60 penalty units.

32CM Exemptions for medical practitioners

(1) The Secretary may, in writing, authorise a specified medical

practitioner to supply a specified biological, for use in the

treatment of humans, to the class or classes of recipients specified

in the authority.

Note: Section 32CN contains criminal offences relating to the giving an authority to a medical practitioner.

(2) The Secretary may give an authority under subsection (1) subject

to any conditions that are specified in the authority.

(3) The Secretary may impose conditions (or further conditions) on an

authority given to a person under subsection (1) by giving to the

person written notice of the conditions (or further conditions).

(4) An authority under subsection (1) may only be given:

(a) to a medical practitioner included in a class of medical

practitioners prescribed by the regulations for the purposes of

this paragraph; or

(b) to a medical practitioner who has the approval of an ethics

committee to supply the specified biological.

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Section 32CN

180 Therapeutic Goods Act 1989

Paragraph (b) does not apply in the exceptional circumstances (if

any) prescribed by the regulations for the purposes of this

subsection.

(5) An authority under subsection (1) may only be given in relation to

a class or classes of recipients prescribed by the regulations for the

purposes of this subsection.

(6) The regulations may prescribe the circumstances in which a

biological may be supplied under an authority under subsection (1).

(7) An authority under subsection (1) is not a legislative instrument.

(8) In this section:

medical practitioner means a person who is registered, in a State

or internal Territory, as a medical practitioner.

32CN Criminal offences relating to the giving of an authority to a

medical practitioner

(1) A person commits an offence if:

(a) the Secretary has authorised, under subsection 32CM(1), the

person to supply a biological; and

(b) the person supplies the biological; and

(i) the supply is not in accordance with the authority;

(ii) the supply is not in accordance with the conditions to

which the authority is subject;

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6); and

(d) either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because:

(i) the supply is not in accordance with the authority; or

(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

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Section 32CN

Therapeutic Goods Act 1989 181

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6).

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

(2) A person commits an offence if:

(a) the Secretary has authorised, under subsection 32CM(1), the

person to supply a biological; and

(b) the person supplies the biological; and

(i) the supply is not in accordance with the authority;

(ii) the supply is not in accordance with the conditions to

which the authority is subject;

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6); and

(d) the use of the biological, if the biological were used, would

be likely to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because:

(i) the supply is not in accordance with the authority; or

(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6).

Penalty: 2,000 penalty units.

(3) An offence against subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the Secretary has authorised, under subsection 32CM(1), the

person to supply a biological; and

(b) the person supplies the biological; and

(i) the supply is not in accordance with the authority;

(ii) the supply is not in accordance with the conditions to

which the authority is subject;

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Section 32CO

182 Therapeutic Goods Act 1989

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 32CM(6).

Penalty for contravention of this subsection:500 penalty units.

Subdivision E—Exempting biologicals where substitutes are

unavailable etc.

32CO Approvals where substitutes for biologicals are unavailable

etc.

(1) The Secretary may, by notice in writing, grant an approval to a

person for:

(a) the importation into Australia of a specified biological; or

(b) the importation into Australia of a specified biological and

the supply in Australia of that biological;

if the Secretary is satisfied that:

substitute for the biological are unavailable or are in short

supply; and

(d) either:

(i) the biological that is the subject of the application for

approval is registered or approved for general marketing

in at least one foreign country specified by the Secretary

under subsection (5); or

(ii) an application that complies with section 32DA or

32DD has been made for inclusion of the biological in

the Register; and

(e) the biological is of a kind specified by the Secretary in a

determination under subsection (6); and

(f) the approval is necessary in the interests of public health.

(2) The Secretary may, by notice in writing, grant an approval to a

person for:

(a) the importation into Australia of a specified biological; or

(b) the importation into Australia of a specified biological and

the supply in Australia of that biological;

if the Secretary is satisfied that:

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Section 32CO

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(d) an application that complies with section 32DA or 32DD has

been made for inclusion of the biological in the Register; and

(e) the biological is of a kind specified by the Secretary in a

determination under subsection (6); and

(f) the approval is necessary in the interests of public health.

Application for approval

(3) An application for an approval must:

(a) be made to the Secretary; and

(b) be accompanied by such information relating to the

biological as is required by the Secretary.

Secretary’s decision

(4) If an application for an approval is made, the Secretary must, after

having considered the application, notify the applicant of the

decision on the application as soon as practicable after making the

decision and, in the case of a decision not to grant the approval, of

the reasons for the decision.

Determinations

(5) The Secretary may, by legislative instrument, make a

determination specifying foreign countries for the purposes of

subparagraph (1)(d)(i).

(6) The Secretary may, by legislative instrument, make a

determination specifying the kinds of biologicals that can be the

subject of an approval under this section.

Conditions

(7) The Secretary may grant an approval subject to any conditions that

are specified in the notice of approval.

(8) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission results in the breach of a condition of an

approval under subsection (1) or (2).

Penalty: 60 penalty units.

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Section 32CO

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Period of approval

(9) The Secretary may grant an approval for such period as is specified

in the notice of approval.

When approval lapses

(10) The approval lapses if:

(a) the period specified in the notice of approval expires; or

(b) a decision has been made on an application that has been

made for inclusion of the biological in the Register.

(11) The approval lapses if:

(a) the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f),

or paragraph (2)(c), (d), (e) or (f), as the case requires, no

longer applies in relation to the biological, or that a condition

of the approval has been contravened; and

(b) the Secretary has given to the person to whom the approval

was granted a notice stating that the Secretary is so satisfied.

(12) The lapsing of the approval on the expiry of the period specified in

the notice of approval does not prevent another approval being

granted under this section in relation to the biological before that

lapsing. The other approval may be expressed to take effect on the

expiry of that period.

Approval not a legislative instrument

(13) An approval under subsection (1) or (2) is not a legislative

instrument.

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Including biologicals in the Register Division 4

Section 32D

Therapeutic Goods Act 1989 185

Division 4—Including biologicals in the Register

Subdivision A—Preliminary

32D What this Division is about

A Class 1 biological can be included in the Register if a proper

application is made and the applicant certifies various matters.

A biological other than a Class 1 biological can be included in the

satisfied the biological is suitable for inclusion following an

evaluation of the biological.

Subdivision B—Class 1 biologicals

32DA Application for inclusion in the Register

(1) A person may make an application to the Secretary to include a

Class 1 biological in the Register.

(2) An application must:

(a) be made in accordance with a form that is approved, in

writing, by the Secretary; and

(b) be accompanied by a statement certifying the matters

mentioned in subsection (3); and

form; and

(d) be accompanied by the prescribed application fee.

(3) The applicant must certify that:

(a) the biological is a Class 1 biological; and

(b) the biological is safe for the purposes for which it is to be

used; and

to it; and

(d) the biological complies with every requirement (if any)

relating to advertising applicable under Part 5-1 or under the

regulations; and

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Section 32DB

186 Therapeutic Goods Act 1989

(e) the biological complies with all prescribed quality or safety

criteria that are applicable to it; and

(f) the biological does not contain substances that are prohibited

imports for the purposes of the Customs Act 1901.

(4) An approval of a form may require or permit an application to be

given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32DB Inclusion of Class 1 biological in the Register

(1) If an application is made in accordance with section 32DA for a

Class 1 biological to be included in the Register in relation to a

person, the Secretary must include the biological in the Register in

relation to the person.

Biological number

(2) If the Secretary includes the biological in the Register, the

Secretary must assign a unique number to the biological. The

number assigned may be any combination of numbers and either or

both of letters and symbols.

Note: The number assigned is the biological number of the biological.

Certificate

(3) As soon as practicable after the biological has been included in the

the inclusion of the biological in the Register.

(4) The certificate must:

(a) specify the biological number of the biological; and

(b) specify the day on which the inclusion of the biological in the

Duration of inclusion in the Register

(5) The biological remains included in the Register in relation to the

person until the Secretary cancels the entry of the biological from

the Register under this Part.

Note: The biological is taken not to be included in the Register while it is suspended: see section 32FD.

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Including biologicals in the Register Division 4

Section 32DC

Therapeutic Goods Act 1989 187

32DC Refusal to include Class 1 biological in the Register

If:

(a) an application is made under subsection 32DA(1) to include

a Class 1 biological in the Register; and

(b) the Secretary refuses the application;

the Secretary must, as soon as practicable after the refusal, give the

person notice of the refusal and of the reasons for the refusal.

Subdivision C—Biologicals other than Class 1 biologicals

32DD Application for inclusion in the Register

(1) A person may make an application to the Secretary to include a

biological, other than a Class 1 biological, in the Register.

(2) An application is not effective unless:

(a) the application is made in accordance with a form that is

approved, in writing, by the Secretary and that relates to that

biological; and

(b) the application is accompanied by any documents that the

form requires; and

specified in the form; and

(d) if the Secretary so requires—the applicant has delivered to

that office a reasonable number of samples of the biological;

and

(e) the application is accompanied by the prescribed application

fee.

Note: An evaluation fee is also payable: see sections 32DI to 32DM.

(3) The Secretary may approve different forms for different classes of

biologicals that are prescribed by the regulations for the purposes

of section 32AA.

(4) An approval of a form may require or permit an application to be

given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

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Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 4 Including biologicals in the Register

Section 32DE

188 Therapeutic Goods Act 1989

32DE Evaluation of biologicals

(1) If an application is made in accordance with section 32DD for a

biological to be included in the Register in relation to a person, the

Secretary must evaluate the biological for inclusion in the Register,

having regard to:

(a) whether the quality, safety and efficacy of the biological for

the purposes for which it is to be used have been

satisfactorily established; and

(b) whether the presentation of the biological is acceptable; and

it; and

(d) whether the biological complies with every requirement (if

any) relating to advertising applicable under Part 5-1 or

under the regulations; and

(e) if a step in the manufacture of the biological has been carried

out outside Australia and the biological is not exempt from

the operation of Part 3-3—whether the manufacturing and

quality control procedures used in the step are acceptable;

and

(f) if a step in the manufacture of the biological has been carried

out in Australia, the biological is not exempt from the

operation of Part 3-3 and the person is not exempt from the

operation of that Part in relation to that step—whether that

step has been carried out in accordance with that Part; and

(g) whether the biological contains substances that are prohibited

imports for the purposes of the Customs Act 1901; and

(h) whether all of the manufacturers of the biological are

nominated as manufacturers of the biological in the

application; and

(i) such other matters (if any) as the Secretary considers

relevant.

(2) For the purposes of paragraph (1)(e), subsections 25(2), (2E), (2F)

and (2G) apply in a way corresponding to the way in which they

apply for the purposes of paragraph 25(1)(g).

32DF Inclusion of biological in the Register

(1) If:

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Section 32DG

Therapeutic Goods Act 1989 189

(a) an application is made in accordance with section 32DD for a

biological to be included in the Register in relation to a

person; and

(b) the Secretary decides that it is appropriate to include the

biological in the Register after an evaluation under

section 32DE; and

and payable by the person remains unpaid;

the Secretary must include the biological in the Register in relation

to the person.

Biological number

(2) If the Secretary includes the biological in the Register, the

Secretary must assign a unique number to the biological. The

number assigned may be any combination of numbers and either or

both of letters and symbols.

Note: The number assigned is the biological number of the biological.

Certificate

(3) As soon as practicable after the biological has been included in the

the inclusion of the biological in the Register.

(4) The certificate must:

(a) specify the biological number of the biological; and

(b) specify the day on which the inclusion of the biological in the

Duration of inclusion in the Register

(5) The biological remains included in the Register in relation to the

person until the Secretary cancels the entry of the biological from

the Register under this Part.

Note: The biological is taken not to be included in the Register while it is suspended: see section 32FD.

32DG Refusal to include biological in the Register

If:

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Part 3-2A Biologicals

Division 4 Including biologicals in the Register

Section 32DH

190 Therapeutic Goods Act 1989

(a) an application is made under subsection 32DD(1) to include

a biological in the Register; and

(b) the Secretary refuses the application;

the Secretary must, as soon as practicable after the refusal, give the

person notice of the refusal and of the reasons for the refusal.

32DH Lapsing of application

(1) An application under subsection 32DD(1) for inclusion of a

biological in the Register lapses if:

(a) any part of the evaluation fee payable in respect of the

biological remains unpaid at the end of the period of 42 days

after the day on which the part became due and payable; or

(b) information given to the Secretary by, or on behalf of, the

applicant in connection with the application, including

information given for the purpose of a requirement under

section 32JA, is false or misleading in a material particular;

section 32JA to give information consisting of patient data in

relation to the biological.

(2) In this section:

patient data, in relation to a biological, means information, derived

from clinical trials, relating to individuals before, during and after

the administration of the biological to those individuals, including,

but not limited to, demographic, biochemical and haematological

information.

32DI Evaluation fee

(1) If an application is made in accordance with section 32DD for a

biological to be included in the Register, an evaluation fee

specified in, or determined in accordance with, the regulations is

payable by the applicant in respect of the evaluation of the

biological for inclusion in the Register.

(2) The Secretary must notify the applicant in writing of the amount of

the evaluation fee.

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Including biologicals in the Register Division 4

Section 32DJ

Therapeutic Goods Act 1989 191

32DJ When evaluation fee due for payment

(1) Subject to sections 32DK and 32DM, an evaluation fee payable by

an applicant is due and payable on the day on which the applicant

is notified of the amount of the evaluation fee.

(2) The evaluation fee is payable in the manner prescribed by the

regulations.

32DK Payment of evaluation fee by instalments

(1) The regulations may provide for the payment of an evaluation fee

to be made by such instalments and at such times as are ascertained

in accordance with the regulations, and the evaluation fee is due

and payable accordingly.

(2) Regulations made for the purposes of subsection (1) may provide

that a person is not allowed to pay an evaluation fee by instalments if

any part of an instalment of that or any other evaluation fee payable

by the person was unpaid immediately after the time when it became

due for payment.

(3) If:

(a) the regulations make provision as mentioned in

subsection (2); and

(b) an instalment of an evaluation fee under section 32DI was

unpaid immediately after the time when it became due for

payment;

the balance of the evaluation fee becomes due and payable

immediately.

(4) Subsection (2) does not limit subsection (1).

32DL Recovery of evaluation fee

An evaluation fee may be recovered by the Commonwealth as a

debt due to the Commonwealth.

32DM Reduction of evaluation fee where evaluation not completed

within prescribed period

(1) Nothing in section 32DI, 32DJ or 32DK requires the applicant to

pay more than 3/4 of the evaluation fee before the completion of the

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Division 4 Including biologicals in the Register

Section 32DN

192 Therapeutic Goods Act 1989

evaluation if a period is prescribed under paragraph 63(2)(daa) for

completing the evaluation.

(2) The Secretary must notify the applicant in writing of the day the

evaluation is completed.

(3) If the evaluation is not completed within that period, the evaluation

fee is 3/4 of the fee that, apart from this subsection, would have

been the evaluation fee.

(4) If:

(a) the evaluation is completed within that period; and

(b) part of the evaluation fee under section 32DI is unpaid when

the evaluation is completed;

that part becomes due and payable on the completion of the

evaluation.

(5) For the purposes of this section, if a copy of the evaluation report,

or a summary of that report, is given to either or both of the

following:

(a) the applicant;

(b) a committee established under the regulations to advise the

Secretary on applications to include biologicals in the

prescribed under paragraph 63(2)(daa);

then the evaluation is taken to be completed immediately before

the first copy or summary is so given.

Note: This subsection has the effect that if the applicant withdraws the application after being given a copy of the evaluation report, or a summary of that report, before the end of that period, the full evaluation fee is due and payable by the applicant.

(6) A notification under subsection (2) is not a legislative instrument.

Subdivision D—Transitional provisions for existing biologicals

32DN Transitional provisions for existing biologicals

Biologicals currently included in the Register

(1) If, immediately before the commencement of this section,

therapeutic goods that are a biological were included in relation to

a person:

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Section 32DN

Therapeutic Goods Act 1989 193

(a) in the part of the Register for goods known as registered

goods; or

(b) in the part of the Register for goods known as listed goods; or

then, as soon as practicable after the commencement of this

section, the Secretary must:

(d) by writing, cancel the inclusion of the goods in that part; and

(e) include the biological in the Register under this Part in

relation to the person; and

(f) vary the Register as a result of that cancellation and

inclusion.

Pending applications

(2) If:

(a) before the commencement of this section, an application was

made for the registration or listing of therapeutic goods that

are a biological or for the inclusion of such goods in the

(b) immediately before that commencement, the application was

not finally determined; and

before or after that commencement; and

(d) the application is successful when it is finally determined;

and

(e) the goods are included:

(i) in the part of the Register for goods known as registered

goods; or

(ii) in the part of the Register for goods known as listed

goods; or

(iii) in the part of the Register for medical devices included

in the Register under Chapter 4;

then, as soon as practicable after that inclusion, the Secretary must:

(f) by writing, cancel the inclusion of the goods in that part; and

(g) include the biological in the Register under this Part in

relation to the person; and

(h) vary the Register as a result of that cancellation and

inclusion.

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Part 3-2A Biologicals

Division 4 Including biologicals in the Register

Section 32DN

194 Therapeutic Goods Act 1989

(3) For the purposes of this section, an application is finally

determined when the application, and any applications for review

or appeals arising out of it, have been finally determined or

otherwise disposed of.

Notice of decisions

(4) The Secretary must give the person written notice of the

cancellation and inclusion under subsection (1) or (2).

Biological number

(5) If the Secretary includes the biological in the Register under

subsection (1) or (2), the Secretary must assign a unique number to

the biological. The number assigned may be any combination of

numbers and either or both of letters and symbols.

Note: The number assigned is the biological number of the biological.

Certificate

(6) As soon as practicable after the biological has been included in the

certificate of the inclusion of the biological in the Register.

(7) The certificate must:

(a) specify the biological number of the biological; and

(b) specify the day on which the inclusion of the biological in the

Duration of inclusion in the Register

(8) The biological remains included in the Register in relation to the

person until the Secretary cancels the entry of the biological from

the Register under this Part.

Note: The biological is taken not to be included in the Register while it is suspended: see section 32FD.

Annual charge

(9) If, during a financial year, the Secretary includes a biological in the

Therapeutic Goods (Charges) Act 1989 does not apply in relation

to the biological for that financial year.

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Including biologicals in the Register Division 4

Section 32DO

Therapeutic Goods Act 1989 195

No review of decisions

(10) A decision under this section is taken not to be an initial decision

for the purposes of section 60.

Subdivision E—Criminal offences and civil penalties

32DO Criminal offences for false statements in applications for

including biologicals in the Register

(1) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in, or in connection with, an

application for inclusion of a biological in the Register; and

and

(d) either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in, or in connection with, an

application for inclusion of a biological in the Register; and

and

(d) the use of the biological, if the biological were used, would

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

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Division 4 Including biologicals in the Register

Section 32DP

196 Therapeutic Goods Act 1989

(3) An offence against subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person makes a statement; and

(b) the statement is made in, or in connection with, an

application for inclusion of a biological in the Register; and

Penalty for contravention of this subsection:Imprisonment for 12

months or 1,000 penalty units, or both.

32DP Civil penalty for false statements in applications for including

biologicals in the Register

A person contravenes this section if the person in, or in connection

with, an application for inclusion of a biological in the Register,

makes a statement that is false or misleading in a material

particular.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

32DQ Criminal offence and civil penalty for failing to notify adverse

effects etc. of biological while it is included in the Register

Criminal offence

(1) A person commits an offence if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person knows that particular information is information

of a kind to which subsection (3) applies; and

within the period specified in the regulations (whether or not

the person has already given to the Secretary other

information relating to the same matter).

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

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Including biologicals in the Register Division 4

Section 32DR

Therapeutic Goods Act 1989 197

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

Civil penalty

(2) A person contravenes this subsection if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person knows that particular information is information

of a kind to which subsection (3) applies; and

within the period specified in the regulations (whether or not

the person has already given to the Secretary other

information relating to the same matter).

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

Relevant information

(3) This subsection applies to information of the following kinds:

(a) information that contradicts information already given by the

person under this Act in relation to the biological (including

information given about the quality, safety or efficacy of the

biologican( �

(b) information that indicates that the use of the biological in

accordance with the recommendations for its use may have

an unintended harmful effect;

accordance with the recommendations for its use, may not be

as effective as the application for inclusion of the biological

in the Register or information already given by the person

under this Act suggests.

32DR Criminal offences and civil penalties for failing to notify

adverse effects etc. of biological where application

withdrawn or lapses

(1) If an application for inclusion of a biological in the Register is

withdrawn or lapses, the Secretary may, within 14 days after the

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Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 4 Including biologicals in the Register

Section 32DR

198 Therapeutic Goods Act 1989

application is withdrawn or lapses, give the applicant written notice

requiring the applicant:

(a) to inform the Secretary in writing whether the applicant is

aware of any information of a kind to which subsection (2)

applies; and

(b) if the applicant is aware of such information, to give the

information to the Secretary in writing.

(2) This subsection applies to information of the following kinds:

(a) information that contradicts information already given by the

person under this Act in relation to the biological (including

information given about the quality, safety or efficacy of the

biologican( �

(b) information that indicates that the use of the biological in

accordance with the recommendations for its use may have

an unintended harmful effect;

accordance with the recommendations for its use, may not be

as effective as the application for inclusion of the biological

in the Register or information already given by the person

under this Act suggests.

Offences

(3) A person commits an offence if:

(a) the Secretary gives a notice to the person under

subsection (1); and

(b) the person fails to comply with the notice within 30 days

after the notice is given to the person.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4) A person commits an offence if:

(a) the person gives information in purported compliance with a

notice under subsection (1); and

(b) the information is false or misleading in a material particular.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

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Including biologicals in the Register Division 4

Section 32DS

Therapeutic Goods Act 1989 199

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

Civil penalties

(5) A person contravenes this subsection if:

(a) the Secretary gives a notice to the person under

subsection (1); and

(b) the person fails to comply with the notice within 30 days

after the notice is given to the person.

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

(6) A person contravenes this subsection if:

(a) the person gives information in purported compliance with a

notice under subsection (1); and

(b) the information is false or misleading in a material particular.

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

Subdivision F—Advice from Gene Technology Regulator

32DS Consultation with Gene Technology Regulator

(1) This section applies to an application for inclusion of a biological

in the Register if the biological is, or contains, a GM product or a

genetically modified organism.

(2) Subject to subsection (5), the Secretary must give written notice to

the Gene Technology Regulator:

(a) stating that the application has been made; and

(b) requesting the Gene Technology Regulator to give advice

about the application.

(3) If the Secretary gives the Gene Technology Regulator a notice

under subsection (2), the Gene Technology Regulator may give

written advice to the Secretary about the application.

(4) The advice is to be given within the period specified in the notice.

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Part 3-2A Biologicals

Division 4 Including biologicals in the Register

Section 32DT

200 Therapeutic Goods Act 1989

(5) If an advice from the Gene Technology Regulator is in force under

section 32DT in relation to a class of biologicals, the Secretary is

not required to notify the Gene Technology Regulator under this

section in relation to an application for inclusion in the Register of

a biological belonging to that class.

(6) A notice under subsection (2) is not a legislative instrument.

32DT Secretary may seek advice about classes of GM products or

genetically modified organisms

(1) The Secretary may request advice from the Gene Technology

Regulator in relation to:

(a) biologicals that consist of, or that contain, a GM product

belonging to a class of GM products specified in the request;

(b) biologicals that consist of, or that contain, genetically

modified organisms belonging to a class of genetically

modified organisms specified in the request.

(2) A request for advice under subsection (1) must specify the matters

to which the advice is to relate.

(3) If the Secretary requests advice from the Gene Technology

Regulator under subsection (1), the Gene Technology Regulator

may provide written advice in relation to the matters specified in

the request.

(4) If the Gene Technology Regulator gives advice to the Secretary

under subsection (3), the advice remains in force until it is

withdrawn by the Gene Technology Regulator by written notice

given to the Secretary.

32DU Secretary to take advice into account

If the Secretary receives advice from the Gene Technology

Regulator:

(a) in response to a notice under section 32DS within the period

specified in the notice; or

(b) under section 32DT;

the Secretary must:

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Section 32DU

Therapeutic Goods Act 1989 201

decision on the application to which the notice relates, or on

an application to which the advice under section 32DT

relates, as the case requires; and

(d) inform the Gene Technology Regulator of the decision on the

application.

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Part 3-2A Biologicals

Division 5 Conditions

Section 32E

202 Therapeutic Goods Act 1989

Division 5—Conditions

32E What this Division is about

Inclusions of biologicals in the Register are subject to certain

automatic conditions. The Minister and the Secretary may impose

further conditions.

32EA Conditions applying automatically

Entry and inspection powers

(1) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will:

(a) allow an authorised person:

(i) to enter, at any reasonable time, any premises (including

premises outside Australia) at which that person or any

other person deals with the biological; and

(ii) while on those premises, to inspect those premises and

any biological on those premises and to examine, take

measurements of, conduct tests on or take samples of

any biological on those premises or any thing on those

premises that relates to any biological; and

(iii) while on those premises, to make any still or moving

image or any recording of those premises or any thing

on those premises; and

(b) if requested to do so by an authorised person, produce to the

person such documents relating to the biological included in

the Register as the person requires and allow the person to

copy the documents.

(2) An authorised person is not authorised to enter premises as

mentioned in subsection (1) unless the person has shown his or her

identity card issued under section 52 if required by the occupier of

the premises. For the purposes of this subsection, occupier, in

relation to premises, includes a person present at the premises who

is in apparent control of the premises.

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Conditions Division 5

Section 32EA

Therapeutic Goods Act 1989 203

Delivery of samples

(3) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will deliver a reasonable number of

samples of the biological if the Secretary so requests:

(a) within the period, of not less than 14 days after the day the

request is made, specified in the request; and

(b) in accordance with any other requirements specified in the

request.

Manufacturing

(4) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will:

(a) if a manufacturer who was not nominated as a manufacturer

of the biological in the application for inclusion of the

biological in the Register is to become a manufacturer of a

step in the manufacture of the biological—inform the

Secretary in writing of that fact and of the name and address

of that manufacturer before that manufacturer begins to carry

out that step; and

(b) if premises that were not nominated in the application as

premises to be used in the manufacture of the biological are

to become premises used in a step in the manufacture of the

biological—inform the Secretary in writing of that fact and

of the name and address of the new premises before the

premises are first so used.

(5) The inclusion of a biological, other than a Class 1 biological, in the

(a) each step in the manufacture of the biological that is carried

out in Australia is carried out by a person who is the holder

of a licence to carry out that step or who is exempt from the

operation of Part 3-3 in relation to that step; and

(b) each step in the manufacture of the biological that is carried

out outside Australia is the subject of a certification in force

under subsection 32EB(2).

(6) Subsection (5) does not apply if the biological is exempt from the

operation of Part 3-3.

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Part 3-2A Biologicals

Division 5 Conditions

Section 32EB

204 Therapeutic Goods Act 1989

(7) Paragraph (5)(b) does not apply in relation to a step that was the

subject of the evaluation under section 32DE. This subsection

ceases to apply in relation to that step if either or both of the

following occur:

(a) that step begins to be carried out at premises that are different

from the premises in respect of which that evaluation was

conducted;

(b) that step begins to be carried out by a manufacturer that is

different from the manufacturer in respect of which that

evaluation was conducted.

Expiry date

(8) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will not supply a batch of the biological in

Australia, or export a batch of the biological from Australia, after

the expiry date for the biological.

Advertising

(9) The inclusion of a biological in the Register is subject to a

condition that the person in relation to whom the biological is

included in the Register will not, by any means, advertise the

biological for an indication other than an indication accepted in

relation to that inclusion.

32EB Certification of manufacturing steps outside Australia

(1) The person in relation to whom a biological, other than a Class 1

biological, is included in the Register may apply to the Secretary

for a certification under this section of a step in the manufacture of

the biological that is to be carried out outside Australia.

(2) If an application is made to the Secretary under this section, the

Secretary may, by writing, certify that the manufacturing and

quality control procedures used in that step are acceptable. The

Secretary must give the person written notice of the certification.

(3) In deciding whether to give the certification, subsections 25(2),

(2E), (2F) and (2G) apply in a way corresponding to the way in

which they apply for the purposes of paragraph 25(1)(g).

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Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Conditions Division 5

Section 32EC

Therapeutic Goods Act 1989 205

32EC Imposition of conditions by legislative instrument

(1) The inclusion of a biological in the Register is subject to the

conditions set out in a determination under subsection (2).

(2) The Minister may, by legislative instrument, make a determination

setting out conditions for the purposes of subsection (1), being

conditions that relate to:

(a) the manufacture of the biological; or

(b) the custody, use, supply, disposal or destruction of the

biological; or

(d) matters dealt with in, or matters additional to matters dealt

with in, standards applicable to the biological; or

(e) such other matters relating to the biological as the Minister

thinks appropriate.

(3) Without limiting subsection (2), different conditions may be

specified for different classes of biologicals.

32ED Imposition of conditions at time biological included in the

Register

(1) If the Secretary includes a biological in the Register in relation to a

person, the Secretary may, by notice in writing given to the person,

impose conditions on the inclusion of the biological in the

(2) A notice under subsection (1) is not a legislative instrument.

32EE Imposition or variation or removal of conditions after

biological included in the Register

(1) The Secretary may, by notice in writing given to the person in

relation to whom a biological is included in the Register, impose

new conditions on the inclusion or vary or remove conditions

imposed under section 32ED or this subsection.

(2) The Secretary’s power under subsection (1) may be exercised at

the request of the person concerned or on the Secretary’s own

initiative. A request must be accompanied by the prescribed fee.

ComLaw Authoritative Act C2013C00132

Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 5 Conditions

Section 32EF

206 Therapeutic Goods Act 1989

(3) The imposition or variation or removal of a condition under

subsection (1) takes effect:

(a) if the notice states that the action is necessary to prevent

imminent risk of death, serious illness or serious injury—on

the day on which the notice is given to the person; or

(b) in any other case—on a later day specified in the notice,

being a day not earlier than 28 days after the notice is given

to the person.

(4) A notice under subsection (1) is not a legislative instrument.

32EF Criminal offences for breach of condition

(1) A person commits an offence if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person does an act or omits to do an act; and

the biological in the Register; and

(d) the act or omission has resulted in, or will result in, harm or

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person does an act or omits to do an act; and

the biological in the Register; and

(d) the act or omission is likely to result in harm or injury to any

person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

ComLaw Authoritative Act C2013C00132

Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Conditions Division 5

Section 32EG

Therapeutic Goods Act 1989 207

(3) An offence against subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person does an act or omits to do an act; and

the biological in the Register.

Penalty for contravention of this subsection:Imprisonment for 12

months or 1,000 penalty units, or both.

32EG Civil penalty for breach of condition

A person contravenes this section if:

(a) a biological is included in the Register in relation to the

person; and

(b) the person does an act or omits to do an act; and

the biological in the Register.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

ComLaw Authoritative Act C2013C00132

Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 6 Suspension from the Register

Section 32F

208 Therapeutic Goods Act 1989

Division 6—Suspension from the Register

32F What this Division is about

The Secretary may suspend biologicals from the Register in certain

circumstances. A biological that is suspended is taken not to be

included in the Register for most purposes.

32FA Suspension of biological from the Register

(1) The Secretary may, by written notice given to a person in relation

to whom a biological is included in the Register, suspend the

biological from the Register if:

(a) the Secretary is satisfied that:

(i) there is a potential risk of death, serious illness or

serious injury if the biological continues to be included

in the Register; and

(ii) it is likely that the person will, within the period of the

suspension, be able to take the action necessary to

ensure that the biological would not cause a potential

risk of death, serious illness or serious injury if the

biological were to continue to be included in the

(b) the Secretary is satisfied that it is likely that there are grounds

for cancelling the entry of the biological from the Register

under Division 7 (other than because of

paragraph 32GA(1)(a) or (d)).

Notice of proposed suspension in some cases

(2) However, before suspending a biological from the Register

because it is likely that there are grounds for cancelling the entry of

the biological from the Register under section 32GC, the Secretary

must:

(a) inform the person by written notice that the Secretary

proposes the suspension and set out the reasons for it; and

(b) invite the person to make written submissions to the

Secretary in relation to the proposed suspension within the

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Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Suspension from the Register Division 6

Section 32FB

Therapeutic Goods Act 1989 209

period specified in the notice (being not less than 28 days

after the day the notice is given).

(3) The Secretary must not make a decision relating to the proposed

suspension until the Secretary has had regard to any submissions

the person makes under paragraph (2)(b).

Period of suspension

(4) A notice under subsection (1) must specify the period of the

suspension (which must not exceed 6 months).

Note: Section 32FB deals with when the suspension takes effect and extensions of the suspension.

Publication in Gazette

(5) As soon as practicable after giving a notice under subsection (1),

the Secretary must cause to be published in the Gazette a notice

setting out particulars of the suspension.

Notice not a legislative instrument

(6) A notice under subsection (1) is not a legislative instrument.

32FB When suspension takes effect etc.

(1) A suspension under section 32FA takes effect:

(a) if the notice under subsection 32FA(1) states that the

suspension is necessary to prevent a potential risk of death,

serious illness or serious injury—on the day on which the

notice is given to the person; or

(b) in any other case—on a later day specified in the notice,

being a day not earlier than 28 days after the notice is given

to the person.

(2) The suspension has effect until:

(a) the Secretary revokes it under section 32FC; or

(b) the end of:

(i) the period specified under subsection 32FA(4); or

(ii) if the period is extended under subsection (3) of this

section—the period as so extended.

ComLaw Authoritative Act C2013C00132

Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 6 Suspension from the Register

Section 32FC

210 Therapeutic Goods Act 1989

Extension of suspension

(3) The Secretary may, by written notice given to the person, extend

the period specified under subsection 32FA(4) by a further

specified period not exceeding 6 months.

Publication in Gazette

(4) As soon as practicable after giving a notice under subsection (3),

the Secretary must cause to be published in the Gazette a notice

setting out particulars of the extension.

Notice not a legislative instrument

(5) A notice under subsection (3) is not a legislative instrument.

32FC Revocation of suspension

(1) The Secretary must revoke a suspension under section 32FA, by

written notice given to the person in relation to whom the

biological is included in the Register, if the Secretary is satisfied

that:

(a) the ground on which the biological was suspended from the

(b) there are no other grounds for suspending the biological from

the Register.

(2) The Secretary’s power to revoke the suspension may be exercised:

(a) if the person in relation to whom the biological is included in

the Register applies in writing to the Secretary; or

(b) on the Secretary’s own initiative.

Publication in Gazette

(3) As soon as practicable after giving a notice under subsection (1),

the Secretary must cause to be published in the Gazette a notice

setting out particulars of the revocation.

Notice of refusal to revoke suspension

(4) If the Secretary decides, after an application is made under

paragraph (2)(a), not to revoke the suspension, the Secretary must:

(a) notify the applicant in writing of his or her decision; and

ComLaw Authoritative Act C2013C00132

Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Suspension from the Register Division 6

Section 32FD

Therapeutic Goods Act 1989 211

(b) state in the notice the reasons for the decision.

Notice not a legislative instrument

(5) A notice under subsection (1) is not a legislative instrument.

32FD Effect of suspension

(1) If a biological is suspended from the Register under section 32FA,

the biological is taken, for the purposes of this Act (other than

section 32DQ, Division 5, sections 32FB and 32FC and

Divisions 7 and 9), not to be included in the Register while the

suspension has effect.

Note: Dealing in a biological that is not included in the Register may be a criminal offence or may contravene a civil penalty provision: see Division 2.

(2) While the suspension has effect, the Secretary’s power under

Division 7 to cancel the entry of the biological from the Register is

not affected.

ComLaw Authoritative Act C2013C00132

Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 7 Cancellation from the Register

Section 32G

212 Therapeutic Goods Act 1989

Division 7—Cancellation from the Register

32G What this Division is about

The Secretary may cancel inclusions of biologicals in the Register

in certain circumstances.

32GA Immediate cancellation of biological from the Register in

various circumstances

(1) The Secretary may, by written notice given to the person in relation

to whom a biological is included in the Register, cancel the entry

of the biological from the Register if:

(a) the Secretary is satisfied that there would be an imminent risk

of death, serious illness or serious injury if the biological

continued to be included in the Register; or

(b) the biological ceases to be a biological or the biological

becomes covered by an order under section 7 declaring goods

not to be therapeutic goods; or

the biological or the biological is exempt under

subsection 32CA(2); or

(d) the person requests in writing the cancellation of the entry of

the biological from the Register; or

(e) the biological contains substances that are prohibited imports

for the purposes of the Customs Act 1901; or

(f) the Secretary is satisfied that a statement made in, or in

connection with, the application for including the biological

in the Register was false or misleading in a material

particular; or

(g) the annual charge payable under the Therapeutic Goods

(Charges) Act 1989 in respect of the inclusion of the

biological in the Register is not paid within 28 days after it

becomes payable; or

(h) the person has failed to comply with a condition mentioned

in subsection 32EA(1) or (3); or

ComLaw Authoritative Act C2013C00132

Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Cancellation from the Register Division 7

Section 32GB

Therapeutic Goods Act 1989 213

(i) both of the following apply:

(i) under the regulations, an authority constituted by or

under the regulations gives a direction to, or makes a

requirement of, the person in relation to an

advertisement of the biological to ensure that

advertising complies with the Therapeutic Goods

Advertising Code;

(ii) the person does not comply with the direction or

requirement; or

(j) there is a breach, involving the biological, of the

requirements relating to advertising applicable under Part 5-1

or under the regulations.

(2) A notice under subsection (1) is not a legislative instrument.

32GB Immediate cancellation of biological from the Register after

failure to comply with information gathering notice

(1) The Secretary may, by written notice given to the person in relation

to whom a biological is included in the Register, cancel the entry

of the biological from the Register if:

(a) the Secretary gives to the person a notice under section 32JA

requiring the person to give to the Secretary information, or

to produce to the Secretary documents, relating to the

biological; and

(b) the notice under section 32JA is given for the purposes of

ascertaining whether the biological should have been

included in the Register; and

within a further 14 days after the end of the period specified

in that notice.

(2) The Secretary may, by written notice given to the person in relation

to whom a biological is included in the Register, cancel the entry

of the biological from the Register if:

(a) the Secretary gives to the person a notice under section 32JA

requiring the person to give to the Secretary information, or

to produce to the Secretary documents, relating to whether

the biological is being:

(i) supplied in Australia; or

(ii) imported into Australia; or

ComLaw Authoritative Act C2013C00132

Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 7 Cancellation from the Register

Section 32GC

214 Therapeutic Goods Act 1989

(iii) exported from Australia; and

(b) either:

(i) the information or documents given are to the effect that

the biological is not being supplied in Australia,

imported into Australia or exported from Australia; or

(ii) the person fails to comply with the notice under

section 32JA within a further 14 days after the end of

the period specified in that notice.

(3) A notice under subsection (1) or (2) is not a legislative instrument.

32GC Cancellation of biological from the Register after notice of

proposed cancellation

(1) The Secretary may, by written notice given to the person in relation

to whom a biological is included in the Register, cancel the entry

of the biological from the Register if:

(a) it appears to the Secretary that the quality, safety or efficacy

of the biological is unacceptable or that the presentation of

the biological is unacceptable; or

(b) the biological has changed so that it has become separate and

distinct from the biological as so included; or

Note: Section 32AB deals with when a biological is separate and distinct from other biologicals.

inclusion of the biological is subject (except a condition

mentioned in subsection 32EA(1) or (3)); or

(d) the Secretary gives to the person a notice under section 32JA:

(i) that requires the person to give to the Secretary

information, or to produce to the Secretary documents,

relating to the biological; and

(ii) in respect of which section 32GB does not apply;

and the person fails to comply with that notice within a

further 14 days after the end of the period specified in that

notice; or

(e) the person contravenes subsection 32DQ(1) or (2) in relation

to the biological; or

(f) the biological does not conform to a standard applicable to it;

ComLaw Authoritative Act C2013C00132

Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Cancellation from the Register Division 7

Section 32GD

Therapeutic Goods Act 1989 215

(g) the biological does not comply with a requirement relating to

advertising applicable to it under Part 5-1 or under the

regulations.

(2) However, before cancelling the entry of the biological from the

(a) inform the person in writing that the Secretary proposes the

cancellation and set out the reasons for it; and

(b) invite the person to make written submissions to the

Secretary in relation to the proposed cancellation within the

period specified in the notice (being not less than 28 days

after the day the notice is given).

(3) The Secretary must not make a decision relating to the proposed

cancellation until the Secretary has had regard to any submissions

the person makes under paragraph (2)(b).

(4) A notice under subsection (1) is not a legislative instrument.

32GD Revocation of cancellation of biological upon request

(1) If:

(a) the Secretary cancels the entry of a biological from the

paragraph 32GA(1)(d); and

(b) before the end of the period of 90 days beginning on the day

the biological ceased to be included in the Register, the

person requests, in writing, the Secretary to revoke the

cancellation; and

the Secretary may, by notice in writing given to the person, revoke

the cancellation.

(2) If the cancellation is revoked, the cancellation is taken never to

have occurred.

32GE Publication of cancellation of entry from Register

The Secretary must cause to be published in the Gazette, as soon as

practicable after cancelling an entry of a biological from the

ComLaw Authoritative Act C2013C00132

Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 7 Cancellation from the Register

Section 32GF

216 Therapeutic Goods Act 1989

32GF Date of effect of cancellation of entries from Register

If the Secretary cancels an entry of a biological from the Register,

the cancellation has effect on the day on which the notice of

cancellation is given to the person in relation to whom the

biological was included in the Register.

ComLaw Authoritative Act C2013C00132

Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Public notification and recovery of biologicals Division 8

Section 32H

Therapeutic Goods Act 1989 217

Division 8—Public notification and recovery of biologicals

32H What this Division is about

The Secretary may require a person to recover biologicals, or to

inform the public about biologicals, that do not comply with

requirements or cannot lawfully be supplied. There are criminal

offences and a civil penalty for breaching such a requirement.

32HA Public notification and recovery of biologicals

(1) The Secretary may, by notice in writing, impose requirements,

relating to a biological, on a person if:

(a) any of the circumstances referred to in the 2nd column of an

item in the following table occur in relation to the biological;

and

(b) the person is referred to in the 3rd column of that item.

Circumstances in which requirements may be imposed

Item Circumstance relating to biological Person subject to

requirements

1 It is supplied while it is included in the

standard applicable to it

The person in relation to

whom it is included in the

2 It is a biological, other than a Class 1

biological, and it is supplied while it is included

in the Register, but the manufacturing

principles have not been observed in its

manufacture

The person in relation to

whom it is included in the

3 It is supplied while:

(a) the person is exempt under

subsection 32CA(1) in relation to the

biological or the biological is exempt under

subsection 32CA(2); or

(b) it is exempt under section 32CB; or

subsection 32CK(1); or

(d) it is the subject of an authority under

The person supplying it

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Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 8 Public notification and recovery of biologicals

Section 32HA

218 Therapeutic Goods Act 1989

Circumstances in which requirements may be imposed

Item Circumstance relating to biological Person subject to

requirements

subsection 32CM(1); or

(e) it is the subject of an approval under

subsection 32CO(1) or (2);

but it does not conform with a standard

applicable to it

4 It is a biological, other than a Class 1

biological, and it is supplied while:

(a) the person is exempt under

subsection 32CA(1) in relation to the

biological or the biological is exempt under

subsection 32CA(2); or

(b) it is exempt under section 32CB; or

subsection 32CK(1); or

(d) it is the subject of an authority under

subsection 32CM(1); or

(e) it is the subject of an approval under

subsection 32CO(1) or (2);

but the manufacturing principles have not been

observed in its manufacture

The person supplying it

5 It is supplied while:

(a) it is not included in the Register; and

(b) the person is not exempt under

subsection 32CA(1) in relation to the

biological and the biological is not exempt

under subsection 32CA(2); and

(d) it is not the subject of an approval under

subsection 32CK(1); and

(e) it is not the subject of an authority under

subsection 32CM(1); and

(f) it is not the subject of an approval under

subsection 32CO(1) or (2)

The person supplying it

6 It is supplied while it is exempt under

section 32CB, and the Secretary is satisfied that

it is not fit to be used for its intended purpose

The person supplying it

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Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Public notification and recovery of biologicals Division 8

Section 32HA

Therapeutic Goods Act 1989 219

Circumstances in which requirements may be imposed

Item Circumstance relating to biological Person subject to

requirements

7 It is supplied in contravention of

subsection 42E(1) or section 42EA

The person supplying it

8 It is a biological, other than a Class 1

biological, and it is supplied while it is included

in the Register, but there is a breach of the

condition set out in subsection 32EA(5)

The person in relation to

whom it is included in the

9 It appears to the Secretary that the quality,

safety or efficacy of the biological is

unacceptable or that the presentation of the

biological is unacceptable

The person in relation to

whom the biological is

included in the Register

10 It has been suspended from the Register The person in relation to

whom it is included in the

11 Its entry has been cancelled from the Register The person in relation to

whom it is included in the

(2) The requirements may be one or more of the following:

(a) to take specified steps, in the specified manner and within

such reasonable period as is specified, to recover the

biological that has been supplied;

(b) to inform the public or a specified class of persons, in the

specified manner and within such reasonable period as is

specified, that the circumstances referred to in

paragraph (1)(a) have occurred in relation to the biological;

reasonable period as is specified, specified information, or

information of a specified kind, relating to the manufacture

or supply of the biological.

(3) If the circumstances referred to in paragraph (1)(a) apply only to a

batch of the biological, the Secretary may limit the imposition of

the requirements to that batch.

(4) A requirement to recover a biological under this section does not

apply to a biological that cannot be recovered because it has been

administered to, or applied in the treatment of, a person.

ComLaw Authoritative Act C2013C00132

Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 8 Public notification and recovery of biologicals

Section 32HB

220 Therapeutic Goods Act 1989

(5) A notice under subsection (1) is not a legislative instrument.

32HB Publication of requirements

The Secretary must cause to be published in the Gazette, as soon as

practicable after imposing a requirement under section 32HA, a

notice setting out particulars of the requirement.

32HC Criminal offences for non-compliance with requirements

(1) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 32HA; and

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 32HA; and

person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) An offence against subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 32HA.

ComLaw Authoritative Act C2013C00132

Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Public notification and recovery of biologicals Division 8

Section 32HD

Therapeutic Goods Act 1989 221

Penalty for contravention of this subsection:Imprisonment for 12

months or 1,000 penalty units, or both.

32HD Civil penalty for non-compliance with requirements

A person contravenes this section if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 32HA.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

32HE Powers of suspension and cancellation unaffected

Imposition of a requirement under section 32HA does not affect

the Secretary’s power to suspend a biological, or cancel the entry

of a biological, from the Register under this Part.

ComLaw Authoritative Act C2013C00132

Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 9 Obtaining information or documents

Section 32J

222 Therapeutic Goods Act 1989

Division 9—Obtaining information or documents

Subdivision A—Preliminary

32J What this Division is about

The Secretary may by written notice seek information or

documents relating to:

• applications for inclusion of biologicals in the Register; or

• biologicals included in the Register; or

• the supply of, and other matters relating to, biologicals

covered by exemptions under Division 3.

There are criminal offences for failing to comply with a notice and

for giving false or misleading information or documents and civil

penalties for giving false or misleading information or documents.

Subdivision B—Obtaining information or documents for

biologicals included or proposed to be included in the

Register

32JA Secretary may require information or documents

(1) The Secretary may, by written notice given to a person:

(a) who is an applicant for the inclusion of a biological in the

(b) in relation to whom a biological is included in the Register;

previous 5 years, included in the Register;

require the person to give to the Secretary information, or to

produce to the Secretary documents, that are relevant to one or

more of the following:

(d) the formulation of the biological;

(e) the composition of the biological;

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Medicines and other therapeutic goods that are not medical devices Chapter 3

Biologicals Part 3-2A

Obtaining information or documents Division 9

Section 32JA

Therapeutic Goods Act 1989 223

(f) the design specifications of the biological;

(g) the quality of the biological;

(h) the method and place of manufacture or preparation of the

biological and the procedures employed to ensure that proper

standards are maintained in the manufacture and handling of

the biological;

(i) the presentation of the biological;

(j) the safety and efficacy of the biological for the purposes for

which it is to be used;

(k) whether the biological conforms with a standard applicable to

it;

(l) whether the biological complies with conditions (if any) on

the inclusion of the biological in the Register;

(m) whether the biological complies with every requirement (if

any) relating to advertising applicable under Part 5-1 or

under the regulations;

(n) if the biological is included in the Register in relation to the

person—whether the biological is being:

(i) supplied in Australia; or

(ii) imported into Australia; or

(iii) exported from Australia;

(o) the regulatory history of the biological in another country;

(p) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

(2) The person must give the information, or produce the documents,

to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

Note: Section 32JB contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 32JC contains a civil penalty for giving false or misleading information or documents.

(3) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

ComLaw Authoritative Act C2013C00132

Chapter 3 Medicines and other therapeutic goods that are not medical devices

Part 3-2A Biologicals

Division 9 Obtaining information or documents

Section 32JB

224 Therapeutic Goods Act 1989

(b) by way of a specified kind of electronic transmission.

(4) If a notice is given under subsection (1) to a person covered by

paragraph (1)(c), then paragraphs (1)(d) to (p) (to the extent to

which they are relevant) apply in relation to that part of the period

of 5 years before the notice was given during which the biological

was included in the Register.

32JB Criminal offences for failing to comply with a notice etc.

(1) A person commits an offence if:

(a) the person is given a notice under section 32JA; and

(b) the person fails to comply with the notice.

Penalty: 500 penalty units.

Note: Failure to comply with the notice might also lead to suspension or cancellation of the entry of a biological in the Register (see Divisions 6 and 7).

(2) A person commits an offence if:

(a) the person is given a notice under section 32JA in relation to

a biological; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular; and

(d) either:

(i) the use of the biological has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the biological, if the biological were used,

would result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) A person commits an offence if:

(a) the person is given a notice under section 32JA in relation to

a biological; and

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(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular; and

(d) the use of the biological, if the biological were used, would

be likely to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4) An offence against subsection (3) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(5) A person commits an offence if:

(a) the person is given a notice under section 32JA; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular.

Penalty for contravention of this subsection:Imprisonment for 12

months or 1,000 penalty units, or both.

32JC Civil penalty for giving false or misleading information or

document in compliance with a notice

A person contravenes this section if:

(a) the person is given a notice under section 32JA; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

32JD Self-incrimination

(1) A person is not excused from giving information or producing a

document under section 32JA on the ground that the information or

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the production of the document might tend to incriminate the

person or expose the person to a penalty.

(2) However, in the case of an individual:

(a) the information given or the document produced; and

(b) giving the information or producing the document; and

indirect consequence of giving the information or producing

the document;

are not admissible in evidence against the individual:

(d) in criminal proceedings, except proceedings for an offence

against subsection 32JB(1), (2), (3) or (5); or

(e) in civil proceedings, except proceedings under section 42Y

for a contravention of section 32JC.

Subdivision C—Obtaining information or documents for

biologicals covered by exemptions

32JE Secretary may require information etc. about biologicals

exempt under the regulations

(1) If a person is exempt under subsection 32CA(1) in relation to a

biological, the Secretary may give the person a written notice

requiring the person to give to the Secretary specified information,

or to produce to the Secretary specified documents, relating to one

or more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

(2) If a biological is exempt under subsection 32CA(2), the Secretary

may give the sponsor of the biological a written notice requiring

the sponsor to give to the Secretary specified information, or to

produce to the Secretary specified documents, relating to one or

more of the following:

(a) the supply of the biological;

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(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Compliance

(3) A person given a notice under subsection (1) or (2) must give the

information, or produce the documents, to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

Note: Section 32JI contains criminal offences for failing to comply with the notice and for giving false or misleading information or documents and section 32JJ contains a civil penalty for giving false or misleading information or documents.

(4) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32JF Secretary may require information etc. about biologicals

exempt to deal with emergencies

(1) This section applies to a person who is required to comply with a

condition of an exemption of a biological under section 32CB.

(2) The Secretary may, by written notice given to the person, require

the person to give to the Secretary specified information, or to

produce to the Secretary specified documents, relating to one or

more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

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(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

(3) The person must give the information, or produce the documents,

to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

(4) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32JG Secretary may require information etc. about biologicals

exempt for special and experimental uses

Approval under subsection 32CK(1)

(1) The Secretary may give to a person who is granted an approval

under subsection 32CK(1) in relation to a biological a written

notice requiring the person to give to the Secretary specified

information, or to produce to the Secretary specified documents,

relating to one or more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Approval under subsection 32CK(1)—use by another person

(2) The Secretary may give to a person (the experimenter) using a

biological that is the subject of an approval:

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(a) that is held by another person under subsection 32CK(1); and

(b) that covers the importation into Australia, or the supply in

Australia, of the biological for use solely for experimental

purposes in humans;

a written notice requiring the experimenter to give to the Secretary

specified information, or to produce to the Secretary specified

documents, relating to either or both of the following:

(d) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Authority under subsection 32CM(1)

(3) The Secretary may give to a person who is granted an authority

under subsection 32CM(1) in relation to a biological a written

notice requiring the person to give to the Secretary specified

information, or to produce to the Secretary specified documents,

relating to one or more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Compliance

(4) A person given a notice under subsection (1), (2) or (3) must give

the information, or produce the documents, to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

(5) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

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(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32JH Secretary may require information etc. about biologicals

exempt where substitutes are unavailable etc.

(1) The Secretary may give to a person who is granted an approval

under subsection 32CO(1) or (2) in relation to a biological a

written notice requiring the person to give to the Secretary

specified information, or to produce to the Secretary specified

documents, relating to one or more of the following:

(a) the supply of the biological;

(b) the handling of the biological;

(d) the results of the supply of the biological;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to a biological of that

kind.

Compliance

(2) A person given a notice under subsection (1) must give the

information, or produce the documents, to the Secretary:

(a) within the period, of not less than 14 days after the day the

notice is given, specified in the notice; and

(b) in the form specified in the notice.

(3) The form may require or permit the information to be given, or the

documents to be produced, in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

32JI Criminal offences for failing to comply with a notice etc.

(1) A person commits an offence if:

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(a) the person is given a notice under section 32JE, 32JF, 32JG

or 32JH; and

(b) the person fails to comply with the notice.

Penalty: 500 penalty units.

(2) A person commits an offence if:

(a) the person is given a notice under section 32JE, 32JF, 32JG

or 32JH; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular.

Penalty for contravention of this subsection:Imprisonment for 12

months or 1,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

32JJ Civil penalty for giving false or misleading information or

document in compliance with a notice

A person contravenes this section if:

(a) the person is given a notice under section 32JE, 32JF, 32JG

or 32JH; and

(b) the person gives information or produces a document in

compliance or purported compliance with the notice; and

material particular.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

32JK Self-incrimination

(1) A person is not excused from giving information or producing a

document under section 32JE, 32JF, 32JG or 32JH on the ground

that the information or the production of the document might tend

to incriminate the person or expose the person to a penalty.

(2) However, in the case of an individual:

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(a) the information given or the document produced; and

(b) giving the information or producing the document; and

indirect consequence of giving the information or producing

the document;

are not admissible in evidence against the individual:

(d) in criminal proceedings, except proceedings for an offence

against subsection 32JI(1) or (2); or

(e) in civil proceedings, except proceedings under section 42Y

for a contravention of section 32JJ.

Subdivision D—Inspecting, copying and retaining documents

32JL Secretary may inspect and copy documents

The Secretary may inspect a document produced under

section 32JA, 32JE, 32JF, 32JG or 32JH and may make and retain

copies of the whole or a part of the document.

32JM Secretary may retain documents

(1) The Secretary may take possession of a document produced under

section 32JA, 32JE, 32JF, 32JG or 32JH, and retain it for as long

as is reasonably necessary.

(2) The person otherwise entitled to possession of the document is

entitled to be supplied, as soon as practicable, with a copy certified

by the Secretary to be a true copy.

(3) The certified copy must be received in all courts and tribunals as

evidence as if it were the original.

(4) Until a certified copy is supplied, the Secretary must provide the

person otherwise entitled to possession of the document, or a

person authorised by that person, reasonable access to the

document for the purposes of inspecting and making copies of the

whole or a part of the document.

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Section 33A

Therapeutic Goods Act 1989 233

Part 3-3—Manufacturing of therapeutic goods

33A Application of this Part to medical devices

This Part does not apply to a medical device unless Part 3-2 applies

to the device.

Note: Section 15A sets out when Part 3-2 applies to a medical device.

33B Application of this Part to biologicals

This Part does not apply to a Class 1 biological.

34 Exempt goods and exempt persons

(1) The regulations may exempt therapeutic goods or a class of

therapeutic goods identified in the regulations from the operation

of this Part.

(2) The regulations may exempt a person identified in the regulations

from the operation of this Part in relation to the manufacture or a

step in the manufacture of therapeutic goods or a class of

therapeutic goods identified in the regulations.

(3) Where the regulations revoke an exemption, the revocation takes

effect on the day, not being earlier than 28 days after the day on

which the regulations are made, as is specified in the regulations.

35 Criminal offences relating to manufacturing therapeutic goods

(1) A person commits an offence if:

(a) the person, at premises in Australia, carries out a step in the

manufacture of therapeutic goods (other than goods exempt

under section 18A or 32CB); and

(b) the goods are for supply for use in humans; and

(i) the goods are exempt goods;

(ii) the person is an exempt person in relation to the

manufacture of the goods;

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(iii) the person is the holder of a licence that is in force that

authorises the carrying out of that step in relation to the

goods at those premises; and

(d) either:

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the person carried out the step in the manufacture of

the goods.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person, at premises in Australia, carries out a step in the

manufacture of therapeutic goods (other than goods exempt

under section 18A or 32CB); and

(b) the goods are for supply for use in humans; and

(i) the goods are exempt goods;

(ii) the person is an exempt person in relation to the

manufacture of the goods;

(iii) the person is the holder of a licence that is in force that

authorises the carrying out of that step in relation to the

goods at those premises; and

(d) the use of the goods, if the goods were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

person carried out the step in the manufacture of the goods.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

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Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person, at premises in Australia, carries out a step in the

manufacture of therapeutic goods (other than goods exempt

under section 18A or 32CB); and

(b) the goods are for supply for use in humans; and

(i) the goods are exempt goods;

(ii) the person is an exempt person in relation to the

manufacture of the goods;

(iii) the person is the holder of a licence that is in force that

authorises the carrying out of that step in relation to the

goods at those premises.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

(5) A person commits an offence if:

(a) the person, at premises in Australia, carries out a step in the

manufacture of therapeutic goods; and

(b) the goods are for supply for use in humans; and

(d) the person is not the holder of a licence that:

(i) is in force; and

(ii) authorises the carrying out of that step in relation to the

goods at those premises; and

(e) either:

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person; and

(f) the harm or injury has resulted, will result, or would result,

because the person carried out the step in the manufacture of

the goods.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (9) instead: see section 53A.

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Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(6) Strict liability applies to paragraph (5)(c).

Note: For strict liability, see section 6.1 of the Criminal Code.

(7) A person commits an offence if:

(a) the person, at premises in Australia, carries out a step in the

manufacture of therapeutic goods; and

(b) the goods are for supply for use in humans; and

(d) the person is not the holder of a licence that:

(i) is in force; and

(ii) authorises the carrying out of that step in relation to the

goods at those premises; and

(e) the use of the goods, if the goods were used, would be likely

to result in harm or injury to any person; and

(f) the harm or injury would be likely to result because the

person carried out the step in the manufacture of the goods.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(8) Subsection (7) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(9) A person commits an offence if:

(a) the person, at premises in Australia, carries out a step in the

manufacture of therapeutic goods; and

(b) the goods are for supply for use in humans; and

(d) the person is not the holder of a licence that:

(i) is in force; and

(ii) authorises the carrying out of that step in relation to the

goods at those premises.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

(10) Strict liability applies to paragraph (9)(c).

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Note: For strict liability, see section 6.1 of the Criminal Code.

35A Civil penalties relating to manufacturing therapeutic goods

(1) A person contravenes this subsection if:

(a) the person carries out a step in the manufacture of therapeutic

goods at premises in Australia; and

(b) the goods are for supply for use in humans; and

(d) none of the following applies:

(i) the goods are exempt goods;

(ii) the person is an exempt person in relation to the

manufacture of the goods;

(iii) the person is the holder of a licence that is in force that

authorises the carrying out of that step in relation to the

goods at those premises.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

(2) A person contravenes this subsection if:

(a) the person carries out a step in the manufacture of therapeutic

goods at premises in Australia; and

(b) the goods are for supply for use in humans; and

(d) the person is not the holder of a licence that:

(i) is in force; and

(ii) authorises the carrying out of that step in relation to the

goods at those premises.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

35B Criminal offences relating to breaching a condition of a licence

(1) A person commits an offence if:

(a) the person holds a licence; and

(b) the person does an act or omits to do an act; and

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(d) the act or omission has resulted in, or will result in, harm or

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

(2) A person commits an offence if:

(a) the person holds a licence; and

(b) the person does an act or omits to do an act; and

(d) the act or omission is likely to result in harm or injury to any

person.

Penalty: 2,000 penalty units.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person holds a licence; and

(b) the person does an act or omits to do an act; and

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

35C Civil penalty relating to breaching a condition of a licence

A person contravenes this section if:

(a) the person holds a licence; and

(b) the person does an act or omits to do an act; and

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

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Section 36

Therapeutic Goods Act 1989 239

36 Manufacturing principles

(1) The Minister may, from time to time, determine written principles

to be observed in the manufacture of therapeutic goods for use in

humans.

(2) The manufacturing principles may relate to:

(a) the standards to be maintained, and the equipment to be used,

at premises used for the manufacturing of therapeutic goods

for use in humans; or

(b) procedures for quality assurance and quality control to be

employed in the manufacturing of therapeutic goods for use

in humans; or

employed in the manufacture of therapeutic goods for use in

humans; or

(d) the manufacturing practices to be employed in the

manufacturing of therapeutic goods for use in humans; or

(e) other matters relevant to the quality, safety and efficacy of

therapeutic goods for use in humans that are manufactured in

Australia;

and may include codes of good manufacturing practice.

(3) The Minister may, before taking action under subsection (1) in

relation to the manufacturing principles, obtain advice from a

committee established by the regulations on the action that should

be taken under that subsection as to the principles to be observed in

the manufacture of therapeutic goods for use in humans.

(4) Manufacturing principles are legislative instruments.

37 Application for licence

(1) An application for a licence must:

(a) be made in accordance with a form approved by the

Secretary; and

(b) identify the therapeutic goods or classes of therapeutic goods

that the applicant proposes to manufacture; and

more manufacturing sites that will be used in the

manufacture of those goods; and

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(d) identify the steps in the manufacture of those goods that the

applicant proposes to carry out under the licence; and

(da) if the applicant proposes to carry out steps in the manufacture

of blood or blood components under the licence—contain

information relating to those steps set out in regulations made

for the purposes of this paragraph; and

(e) state the names, qualifications and experience of the persons

who are to have control of the production of the goods and of

the quality control measures that are to be employed; and

(f) be delivered to an office of the Department specified in the

form; and

(g) be accompanied by the prescribed application fee.

Manufacturing sites

(1A) Subject to subsection (1B), an application under subsection (1)

must relate to one manufacturing site only. This does not prevent

other applications from relating to other manufacturing sites.

(1B) If an applicant is of the view that, having regard to the guidelines

under section 38A, a licence could be granted covering 2 or more

manufacturing sites, the applicant may:

(a) identify those sites in the application; and

(b) state the applicant’s reasons for the applicant’s view.

Further information

(2) The Secretary may, by notice in writing given to an applicant for a

licence, require the applicant:

(a) to give to the Secretary, within such reasonable time as is

specified in the notice, such further information concerning

the application as is specified in the notice; or

(b) to allow an authorised person, at any reasonable time

specified in the notice, to inspect each manufacturing site

identified in the application and the equipment, processes and

facilities that will be used in the manufacture of the goods, or

other goods at that site.

Applications or information may be given electronically

(3) An approval of a form mentioned in paragraph (1)(a), or a notice

mentioned in subsection (2), may require or permit an application

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or information to be given in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

38 Grant of licence

(1) Where:

(a) a person has made an application to carry out steps in the

manufacture of therapeutic goods at one or more

manufacturing sites; and

(b) the prescribed application fee has been paid; and

(d) the applicant has complied with any requirements made by

the Secretary under subsection 37(2) in relation to the

application;

the Secretary must grant the applicant a licence covering one or

more manufacturing sites specified in the licence unless the

Secretary is satisfied that:

(e) the applicant will be unable to comply with the

manufacturing principles; or

(f) one or more of the manufacturing sites identified in the

application are not satisfactory for the manufacture of the

goods; or

(g) at least one of the following persons:

(i) the applicant;

(ii) a person (a manager) who makes, or participates in

making, decisions that affect the whole, or a substantial

part, of the applicant’s affairs;

(iii) if the applicant is a body corporate—a major interest

holder of the body corporate;

has, within the 10 years immediately before the application:

(iv) been convicted of an offence against this Act or a

corresponding State law; or

(v) been convicted of an offence against a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

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(vi) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of this Act or

a corresponding State law; or

(vii) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(viii) breached a condition of a manufacturing licence; or

(ix) had a manufacturing licence suspended or revoked; or

(x) been a manager, or a major interest holder, of a body

corporate in respect of which subparagraph (iv), (v),

(vi), (vii), (viii) or (ix) applies in that 10 year period, if

the conduct resulting in that subparagraph applying

occurred when the person was a manager or major

interest holder of the body corporate; or

(h) any other circumstances prescribed by the regulations for the

purposes of this paragraph exist.

Interpretation

(1A) A reference in paragraph (1)(g) to a person convicted of an offence

includes a reference to a person in respect of whom an order has

been made relating to the offence under:

(a) section 19B of the Crimes Act 1914; or

(b) a corresponding provision of a law of a State or Territory.

Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

(1AA) Paragraph (1)(g) does not limit paragraph (1)(h).

(1B) In paragraph (1)(g):

manufacturing licence means:

(a) a licence granted under this Part; or

(b) a licence, granted under a law of a State or Territory relating

to therapeutic goods, relating to manufacturing therapeutic

goods.

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Special circumstances justifying grant of licence

(2) Notwithstanding paragraph (1)(g), the Secretary may grant a

licence to an applicant who, apart from this subsection, could not

be granted a licence because of that paragraph if, in the opinion of

the Secretary, special circumstances make it appropriate to do so.

Guidelines

(2A) The Secretary must have regard to the guidelines under

section 38A in granting licences under this section.

What the licence authorises

(2B) For each manufacturing site covered by a licence, the Secretary

must authorise, in the licence, the holder of the licence to carry out

specified steps in the manufacture of specified therapeutic goods at

that manufacturing site.

Note 1: For specification by class, see subsection 33(3AB) of the Acts Interpretation Act 1901.

Note 2: Sections 40A and 40B deal with variation of authorisations.

Notice of decision

(3) Where the Secretary grants or refuses to grant a licence to an

applicant, the Secretary must:

(a) give the applicant written notice of the decision; and

(b) in the case of a refusal—include in the notice the reasons for

the refusal.

Publication in Gazette

(4) Where the Secretary grants a licence, the Secretary must cause

particulars of the decision to be published in the Gazette as soon as

is practicable after the decision is made.

38A Guidelines for multi-site licences

The Secretary must, by legislative instrument, make guidelines

setting out the circumstances in which a licence may cover 2 or

more manufacturing sites.

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38B Splitting multi-site licences

(1) This section applies if a licence (the old licence):

(a) either:

(i) was in force under this Part immediately before the

commencement of this section; or

(ii) was suspended under this Part immediately before that

commencement; and

(b) related to premises that comprise 2 or more sites (the old

sites).

(2) As soon as practicable after the commencement of this section, the

Secretary must:

(a) by writing, revoke the old licence; and

(b) on the day that the Secretary revokes the old licence, grant

new licences (each of which is a new licence) to the holder of

the old licence which, when considered together, cover the

old sites.

The Secretary must give the holder written notice of the revocation

and grant.

Note: Subsections (5) and (6) deal with when each new licence commences and when the old licence ends.

Guidelines

(3) The Secretary must have regard to the guidelines under

section 38A in granting licences under this section.

Application of this Part

(4) Subject to this section, subsections 38(2B) and (4) and sections 39

to 41A apply to a new licence in the same way as they apply to a

licence granted under section 38.

Note: This means, for example, that:

(a) the Secretary must give a manufacturing site authorisation under subsection 38(2B) in relation to each manufacturing site covered by a new licence; and

(b) the Secretary may impose conditions on a new licence under subsection 40(1) and the statutory conditions under subsection 40(4) will apply to a new licence; and

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Commencement of new licence

(5) The day specified under subsection 39(1) for the commencement

of each new licence granted to the holder of the old licence must be

the day (the transition day) after the day each new licence is

granted.

Note: Subsection (7) deals with suspending a new licence from the transition day.

When revocation of old licence takes effect

(6) The revocation of the holder’s old licence takes effect immediately

before the start of the transition day.

Suspension of new licence

(7) If:

(a) subparagraph (1)(a)(ii) applies in relation to an old licence;

and

(b) the period of suspension of the old licence is due to end at the

end of a day (the relevant day) after the transition day;

the Secretary may, on the day that the Secretary grants a new

licence to the holder of the old licence and by notice in writing

given to the holder, suspend the new licence for a period starting

on the transition day and ending at the end of the relevant day.

(8) Subsection 41(2) does not apply in relation to a suspension under

subsection (7) of this section. However, subsections 41(4) to (6) do

apply in relation to the suspension.

(9) To avoid doubt, subsection (7) does not prevent subsection 41(1)

from applying in relation to a new licence.

Licence charges

(10) Subsection 4(2) of the Therapeutic Goods (Charges) Act 1989 does

not apply in relation to a new licence for the financial year in

which the new licence is granted.

No review of revocation of old licence

(11) The revocation of the old licence is taken not to be an initial

decision for the purposes of section 60.

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39 Term of licence

(1) A licence commences on the day specified in the licence and

remains in force until it is revoked or suspended.

(2) If:

(a) the licence covers therapeutic goods that are exempt under

section 18A; and

(b) those goods cease to be exempt under that section before the

licence is revoked;

the licence ceases to be in force in relation to those goods when

those goods cease to be exempt under that section.

Note: An exemption under section 18A may cease to have effect only in relation to some of the goods covered by the exemption, see subsection 18A(5).

(3) If:

(a) the licence covers a biological that is exempt under

section 32CB; and

(b) the biological ceases to be exempt under that section before

the licence is revoked;

the licence ceases to be in force in relation to the biological when

the biological ceases to be exempt under that section.

Note: An exemption under section 32CB may cease to have effect only in relation to some of the biologicals covered by the exemption: see subsections 32CB(5) and 32CD(1).

40 Conditions of licences

(1) A licence may be granted subject to such conditions relating to the

manufacture of the goods as the Secretary thinks appropriate.

(2) The Secretary may, by notice in writing given to the holder of a

licence, impose new conditions on the licence or vary or remove

existing conditions.

(3) The imposition or variation of a condition under subsection (2)

takes effect:

(a) if the notice states that the action is necessary to prevent

imminent risk of death, serious illness or serious injury—on

the day on which the notice is given to the person; or

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(b) in any other case—on the day specified for the purpose in the

notice, being a day not earlier than 28 days after the notice is

given to the person.

(4) In addition to any conditions imposed under subsection (1) or (2),

each licence is, except as otherwise specified in the licence, subject

to the conditions that the holder of the licence will:

(a) ensure that:

(i) the goods conform to any standard applicable to the

goods; and

(ii) the holder of the licence observes the manufacturing

principles in carrying out any steps in the manufacture

of the goods under the licence;

unless:

(iii) the goods are a biological and are for supply after the

circumstances prescribed by the regulations for the

purposes of paragraphs 14(9A)(b) and 14A(2A)(b) have

occurred; or

(iv) the goods are a biological and are for export after the

circumstances prescribed by the regulations for the

purposes of paragraphs 14(13A)(b) and 14A(3A)(b)

have occurred; and

(aa) if:

(i) the holder of the licence carries out, or proposes to carry

out, steps in the manufacture of blood or blood

components under the licence; and

(ii) regulations made for the purposes of this paragraph set

out particular information relating to those steps;

comply with a request by the Secretary to provide such

information, in accordance with those regulations; and

(ab) as soon as the holder of the licence becomes aware of

information of a kind mentioned in subsection (5), give the

information to the Secretary in writing; and

(ac) give the Secretary the information specified in a notice under

subsection (6) within the period, and in the manner, specified

in the notice; and

(b) allow an authorised person:

(i) to enter, at any reasonable time, each manufacturing site

covered by the licence; and

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(ii) while at such a site, to inspect the site, any therapeutic

goods at the site and the processes relating to the

manufacture of therapeutic goods at the site and to

examine, take measurements of, conduct tests on or take

samples of any therapeutic goods at the site or any thing

at the site that relates to any therapeutic goods; and

(iii) while at such a site, to make any still or moving image

or any recording of that site or those goods or processes;

and

subparagraph (b)(i), require the holder or his or her

employees at that site to answer questions relating to

procedures carried out at that site; and

(d) if requested to do so by an authorised person:

(i) produce to the person such documents relating to the

manufacture of therapeutic goods manufactured at that

site as the person requires and allow the person to copy

the documents; or

(ii) produce to the person for examination any batch

samples kept by the holder; and

(e) comply with such other conditions (if any) as are specified in

the regulations for the purposes of this section.

(5) The information with which paragraph (4)(ab) is concerned is

information of the following kinds:

(a) information that indicates that the use of the goods in

accordance with the recommendations for their use may have

an unintended harmful effect;

(b) information that indicates that the goods, when used in

accordance with the recommendations for their use, may not

be as effective as was suggested by:

(i) the application for registration or listing of the goods; or

(ii) information already furnished by the holder of the

licence under this Act; or

(iii) if the holder of the licence is not the sponsor of the

goods—information already furnished by the sponsor of

the goods under this Act;

of the goods is unacceptable.

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(6) The Secretary may, by notice in writing given to the holder of a

licence, require the holder to give the Secretary, within the

specified period and in the specified manner, specified information

to be used by the Secretary in deciding whether to revoke or

suspend the licence under section 41 in the circumstances referred

to in paragraph 41(1)(a).

(7) The period specified in a notice given under subsection (6) must be

at least 14 days after the notice is given.

40A Variation of manufacturing site authorisations—Secretary’s

own initiative

(1) The Secretary may, on his or her own initiative and by notice in

writing given to the holder of a licence, vary a manufacturing site

authorisation in relation to the licence.

(2) A variation under subsection (1) takes effect:

(a) if the notice states that the variation is necessary to prevent

imminent risk of death, serious illness or serious injury—on

the day on which the notice is given to the holder; or

(b) in any other case—on the day specified in the notice (which

must not be earlier than 28 days after the notice is given to

the holder).

40B Variation of licences—application by licence holder

Addition of manufacturing sites

(1) If the holder of a licence is of the view that, having regard to the

guidelines under section 38A, the licence could cover one or more

additional manufacturing sites, the holder may apply to the

Secretary for a variation of the licence so that it covers one or more

additional manufacturing sites specified in the application.

(2) An application under subsection (1) must:

(a) be made in accordance with a form approved by the

Secretary; and

(b) identify the therapeutic goods or classes of therapeutic goods

that the holder proposes to manufacture at each additional

manufacturing site specified in the application; and

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holder proposes to carry out under the licence; and

(d) if the holder proposes to carry out steps in the manufacture of

blood or blood components under the licence—contain

information relating to those steps set out in regulations made

for the purposes of paragraph 37(1)(da); and

(e) state the names, qualifications and experience of the persons

who are to have control of the manufacture of the goods and

of the quality control measures that are to be employed; and

(f) be delivered to an office of the Department specified in the

form; and

(g) be accompanied by the prescribed application fee.

(3) If an application is made under subsection (1) and any applicable

prescribed inspection fees have been paid, the Secretary may, by

notice in writing given to the holder of the licence, vary the licence

so that the licence covers each additional manufacturing site

specified in the notice.

(4) For each manufacturing site specified under subsection (3), the

Secretary must, in the notice under that subsection, vary the licence

to authorise the holder of the licence to carry out specified steps in

the manufacture of specified therapeutic goods at that

manufacturing site.

Note 1: For specification by class, see subsection 33(3AB) of the Acts Interpretation Act 1901.

Note 2: Section 40A and subsections (6) to (9) of this section deal with variation of authorisations.

(5) A variation under subsection (3) or (4) takes effect on the day on

which the notice is given to the holder.

Variation of manufacturing site authorisations

(6) The holder of a licence may apply to the Secretary for a variation

of a manufacturing site authorisation in relation to the licence.

(7) An application under subsection (6) must:

(a) be made in accordance with a form approved by the

Secretary; and

(b) set out the variation sought; and

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form; and

(d) be accompanied by the prescribed application fee.

(8) If an application is made under subsection (6) and any applicable

prescribed inspection fees have been paid, the Secretary may, by

notice in writing given to the holder of the licence, vary the

manufacturing site authorisation.

(9) A variation under subsection (8) takes effect on the day on which

the notice is given to the holder.

Further information

(10) The Secretary may, by notice in writing given to the holder of a

licence who has made an application under subsection (1) or (6),

require the holder:

(a) to give to the Secretary, within such reasonable time as is

specified in the notice, such further information concerning

the application as is specified in the notice; or

(b) to allow an authorised person, at any reasonable time

specified in the notice, to inspect each manufacturing site

identified in the application and the equipment, processes and

facilities that will be used in the manufacture of therapeutic

goods at that site.

Applications or information may be given electronically

(11) An approval of a form mentioned in paragraph (2)(a) or (7)(a), or a

notice mentioned in subsection (10), may require or permit an

application or information to be given in accordance with specified

software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

41 Revocation and suspension of licences

(1) Subject to subsection (2), the Secretary may, by notice in writing

given to the holder of a licence, revoke the licence, or suspend the

licence for a period specified in the notice, if:

(a) at least one of the following persons:

(i) the holder;

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(ii) a person (a manager) who makes, or participates in

making, decisions that affect the whole, or a substantial

part, of the holder’s affairs;

(iii) if the holder is a body corporate—a major interest

holder of the body corporate;

has:

(iv) been convicted of an offence against this Act or a

corresponding State law; or

(v) been convicted of an offence against a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(vi) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of this Act or

a corresponding State law; or

(vii) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(viii) breached a condition of a manufacturing licence; or

(ix) had a manufacturing licence suspended or revoked; or

(x) been a manager, or a major interest holder, of a body

corporate in respect of which subparagraph (iv), (v),

(vi), (vii), (viii) or (ix) applies, if the conduct resulting

in that subparagraph applying occurred when the person

was a manager or major interest holder of the body

corporate; or

(d) the holder requests in writing that the licence be revoked or

suspended, as the case may be; or

(e) the holder ceases to carry on the business of manufacturing

the goods to which the licence relates; or

(ea) the holder contravenes a manufacturing site authorisation in

relation to the licence; or

(f) the annual licensing charge, or any applicable prescribed

inspection fees, have not been paid within 28 days after they

become payable; or

(g) the goods are exempt under section 18A and the holder has

breached a condition of the exemption in relation to those

goods; or

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(ga) the licence covers a biological that is exempt under

section 32CB and the holder has breached a condition of the

exemption in relation to the biological; or

(h) any other circumstances prescribed by the regulations for the

purposes of this paragraph exist.

(1A) A reference in paragraph (1)(a) to a person convicted of an offence

includes a reference to a person in respect of whom an order has

been made relating to the offence under:

(a) section 19B of the Crimes Act 1914; or

(b) a corresponding provision of a law of a State or Territory.

Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

(1B) Paragraph (1)(a) does not limit paragraph (1)(h).

(1C) In paragraph (1)(a):

manufacturing licence means:

(a) a licence granted under this Part; or

(b) a licence, granted under a law of a State or Territory relating

to therapeutic goods, relating to manufacturing therapeutic

goods.

(2) Where the Secretary proposes to revoke a licence or suspend a

licence otherwise than at the request of the holder of the licence,

the Secretary must, unless the Secretary considers that failure to

revoke or suspend the licence immediately would create an

imminent risk of death, serious illness or serious injury:

(a) by notice in writing given to the holder, inform the holder of

the action that the Secretary proposes to take and of the

reasons for that proposed action; and

(b) except where the proposed action is to be taken as a result of

a failure to pay the annual licensing charge or an applicable

prescribed inspection fee—give the holder an opportunity to

make, within such reasonable time as is specified in the

notice, submissions to the Secretary in relation to the

proposed action.

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(3) Where the holder makes submissions in accordance with

paragraph (2)(b), the Secretary is not to make a decision relating to

the revocation or suspension of the licence before taking into

account the submissions.

(4) A licence may be revoked notwithstanding that the licence is

suspended.

(5) Where a licence is suspended, the Secretary may, by notice in

writing given to the holder of the licence, revoke the suspension.

(6) Where the Secretary revokes or suspends a licence, the Secretary

must cause particulars of the decision to be published in the

Gazette as soon as is practicable after the decision is made.

41AA Spent convictions scheme

Nothing in section 40 or 41 affects the operation of Part VIIC of

the Crimes Act 1914 (which includes provisions that, in certain

circumstances, relieve persons from the requirement to disclose

spent convictions and require persons aware of such convictions to

disregard them).

41AAA Transfer of licences

(1) The regulations may make provision for and in relation to the

transfer of licences.

(2) Regulations made for the purposes of subsection (1) may make

provision for and in relation to:

(a) the making of an application for the transfer of a licence; and

(b) the payment of a fee in respect of an application; and

(d) the conditions of a licence upon the transfer of the licence;

and

(e) the review of decisions made under the regulations.

(3) Subsection (2) does not limit subsection (1).

41A Publication of list of manufacturers etc.

The Secretary may, from time to time and in such manner as the

Secretary determines, publish a list of the persons who are licensed

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under this Part, the classes of goods to which the licences relate,

the steps of manufacture that the licences authorise and the

addresses of the manufacturing sites to which the licences relate.

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Chapter 4 Medical devices

Part 4-1 Introduction

Division 1 Overview of this Chapter

Section 41B

256 Therapeutic Goods Act 1989

Chapter 4—Medical devices Note: This Chapter does not apply, and Chapter 3 (Medicines and other therapeutic goods that

are not medical devices) still applies, to medical devices that are registered or listed goods. Section 9B automatically cancels the registration or listing of those goods over time.

Part 4-1—Introduction

Division 1—Overview of this Chapter

41B General

The purpose of this Chapter is to ensure the safety and satisfactory

performance of medical devices. It does this by:

(a) setting out particular requirements for medical devices; and

(b) establishing administrative processes principally aimed at

ensuring those requirements are met; and

civil penalty provisions.

41BA Requirements for medical devices (Parts 4-2 and 4-3)

The requirements for medical devices are:

(a) essential principles (that are about the safety and

performance characteristics of medical devices); and

(b) conformity assessment procedures (that are mainly about the

application of quality management systems).

Note: Medical device standards may be made under Division 2 of Part 4-2, and conformity assessment standards may be made under Division 2 of Part 4-3, but they are not requirements.

41BB Administrative processes (Parts 4-4 to 4-10)

The administrative processes under this Chapter are:

(a) issuing conformity assessment certificates for some

manufacturers of medical devices; and

(b) including medical devices in the Register; and

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(ca) exempting medical devices from various provisions of this

Chapter to deal with emergency situations; and

(d) exempting medical devices from the requirement to be

included in the Register; and

(e) obtaining information about medical devices; and

(f) requiring public notification of problems with medical

devices, and recovery of such devices.

Note: Part 4-10 provides for assessment fees to be payable in some circumstances.

41BC Enforcement (Part 4-11)

Part 4-11 contains offences and civil penalty provisions that are

aimed at ensuring that:

(a) the requirements for medical devices are complied with; and

(b) the administrative processes under this Chapter (particularly

the inclusion of medical devices in the Register) are

followed.

Note: There are some offences and civil penalty provisions in Parts 4-4 to 4-9. They generally relate to matters ancillary to administrative processes in those Parts (e.g. false or misleading statements in applications).

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Chapter 4 Medical devices

Part 4-1 Introduction

Division 2 Interpretation

Section 41BD

258 Therapeutic Goods Act 1989

Division 2—Interpretation

41BD What is a medical device

(1) A medical device is:

(a) any instrument, apparatus, appliance, material or other article

(whether used alone or in combination, and including the

software necessary for its proper application) intended, by

the person under whose name it is or is to be supplied, to be

used for human beings for the purpose of one or more of the

following:

(i) diagnosis, prevention, monitoring, treatment or

alleviation of disease;

(ii) diagnosis, monitoring, treatment, alleviation of or

compensation for an injury or disability;

(iii) investigation, replacement or modification of the

anatomy or of a physiological process;

(iv) control of conception;

and that does not achieve its principal intended action in or

on the human body by pharmacological, immunological or

metabolic means, but that may be assisted in its function by

such means; or

(aa) any instrument, apparatus, appliance, material or other article

specified under subsection (2A); or

(ab) any instrument, apparatus, appliance, material or other article

that is included in a class of instruments, apparatus,

appliances, materials or other articles specified under

subsection (2B); or

(b) an accessory to an instrument, apparatus, appliance, material

or other article covered by paragraph (a), (aa) or (ab).

Note: Declarations under subsection (3) exclude articles from the scope of this definition. Declarations under section 7 can also have this effect: see subsection 7(4).

(2) For the purposes of paragraph (1)(a), the purpose for which an

instrument, apparatus, appliance, material or other article (the main

equipment) is to be used is to be ascertained from the information

supplied, by the person under whose name the main equipment is

or is to be supplied, on or in any one or more of the following:

(a) the labelling on the main equipment;

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(b) the instructions for using the main equipment;

(d) technical documentation describing the mechanism of action

of the main equipment.

(2A) The Secretary may, by notice published in the Gazette, specify a

particular instrument, apparatus, appliance, material or other article

for the purposes of paragraph (1)(aa). The notice is not a legislative

instrument.

(2B) The Secretary may, by legislative instrument, specify a particular

class of instruments, apparatus, appliances, materials or other

articles for the purposes of paragraph (1)(ab).

(3) The Secretary may, by order published in the Gazette, declare that

a particular instrument, apparatus, appliance, material or other

article, or that a particular class of instruments, apparatus,

appliances, materials or other articles, are not, for the purposes of

this Act, medical devices.

Note: A declaration under this section does not stop articles from being therapeutic goods.

(4) A declaration under this section takes effect on the day on which

the declaration is published in the Gazette or on such later day as is

specified in the order.

41BE Kinds of medical devices

General

(1) For the purposes of this Chapter, a medical device is taken to be of

the same kind as another medical device if they:

(a) have the same sponsor; and

(b) have the same manufacturer; and

subsection (3)); and

(d) have the same medical device classification; and

(e) are the same in relation to such other characteristics as the

regulations prescribe, either generally or in relation to

medical devices of the kind in question.

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Chapter 4 Medical devices

Part 4-1 Introduction

Division 2 Interpretation

Section 41BEA

260 Therapeutic Goods Act 1989

Unique medical devices

(2) If a medical device is not of the same kind as any other medical

device:

(a) this Chapter applies in relation to the device as if it were a

kind of medical device; and

(b) references in this Chapter to delivering a reasonable number

of samples of the kind of device are taken to be references to

delivering the device.

Device nomenclature codes

(3) The Minister may, by legislative instrument, determine device

nomenclature codes for medical devices.

41BEA Excluded purposes

The Secretary may, by legislative instrument, specify purposes for

the purposes of paragraph 41FD(ia) and subsection 41FF(1A).

41BF System or procedure packs

(1) A package and therapeutic goods in the package are a system or

procedure pack if:

(a) the package and the therapeutic goods are for use as a unit,

either in combination as a system or in a medical or surgical

procedure; and

(b) the package contains at least one medical device; and

composite pack.

(2) To avoid doubt, a system or procedure pack is a medical device.

41BG Manufacturers of medical devices

(1) The manufacturer of a medical device is the person who is

responsible for the design, production, packaging and labelling of

the device before it is supplied under the person’s name, whether

or not it is the person, or another person acting on the person’s

behalf, who carries out those operations.

(2) If subsection (1) does not apply to a medical device, the

manufacturer of the device is the person who, with a view to

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Introduction Part 4-1

Interpretation Division 2

Section 41BH

Therapeutic Goods Act 1989 261

supplying the device under the person’s name, does one or more of

the following using ready-made products:

(a) assembles the device;

(b) packages the device;

(d) fully refurbishes the device;

(e) labels the device;

(f) assigns to the device its purpose by means of information

supplied, by the person, on or in any one or more of the

following:

(i) the labelling on the device;

(ii) the instructions for using the device;

(iii) any advertising material relating to the device;

(iv) technical documentation describing the mechanism of

action of the device.

(3) However, a person is not the manufacturer of a medical device if:

(a) the person assembles or adapts the device for an individual

patient; and

(b) the device has already been supplied by another person; and

intended for the device by means of information supplied by

that other person, on or in any one or more of the following:

(i) the labelling on the device;

(ii) the instructions for using the device;

(iii) any advertising material relating to the device;

(iv) technical documentation describing the mechanism of

action of the device.

(4) A person is not the manufacturer of a medical device if the person

is included in a class of persons prescribed by the regulations for

the purposes of this subsection.

41BH Meaning of compliance with essential principles

(1) A medical device complies, for the purposes of this Chapter

(including Part 4-11), with the essential principles if and only if it

does not contravene any of the essential principles.

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Part 4-1 Introduction

Division 2 Interpretation

Section 41BI

262 Therapeutic Goods Act 1989

(2) However, a medical device is also taken, for the purposes of this

Chapter (other than Part 4-11), to comply with the essential

principles if:

(a) the medical device complies with one or more medical

device standards that apply to it; and

(b) the medical device contravenes the essential principles only

in respect of a part or parts of the essential principles to

which that medical device standard, or one or more of those

medical device standards, relate.

(3) For the purposes of this section, a medical device standard relates

to a part or parts of the essential principles only if the standard

specifies that part or parts.

41BI Meaning of non-application of conformity assessment

procedures

(1) A conformity assessment procedure is taken, for the purposes of

this Chapter, not to have been applied to a medical device if:

(a) there has been a contravention of the conformity assessment

procedures; and

(b) the contravention relates, wholly or partly, to that device or

its manufacture.

(2) However, for the purposes of this Chapter (other than Part 4-11),

subsection (1) does not apply if:

(a) the quality management system applied in the manufacture of

the medical device complies with one or more conformity

assessment standards that apply to it; and

(b) the contravention is only in respect of a part or parts of the

conformity assessment procedures to which that conformity

assessment standard, or one or more of those conformity

assessment standards, relate.

(3) For the purposes of this section, a conformity assessment standard

relates to a part or parts of the conformity assessment procedures

only if the standard specifies that part or parts.

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Introduction Part 4-1

Application provisions Division 3

Section 41BJ

Therapeutic Goods Act 1989 263

Division 3—Application provisions

41BJ Application of this Chapter to medical devices covered by

Part 3-2

(1) This Chapter does not apply to a medical device if section 15A

applies to the device, except for purposes connected with:

(a) applications for including the medical device in the Register

under this Chapter; or

(b) including the medical device in the Register under this

Chapter.

Note: Section 15A sets out the circumstances in which Part 3-2 applies or continues to apply to medical devices.

(2) However, if an exemption under section 34 applied to a medical

device, or the manufacturer of the device, immediately before the

commencement of this Chapter:

(a) Parts 4-3 and 4-4, and Division 2 of Part 4-11, apply in

relation to the device after the end of the period of 2 years

after that commencement; and

(b) Parts 4-8, 4-9 and 4-10, and Divisions 3 and 4 of Part 4-11,

apply in relation to the device, to the extent that they relate to

any of the provisions referred to in paragraph (a), after the

end of that period.

41BJA Application of this Chapter to a biological

(1) Subject to this section, this Chapter does not apply to a biological

on and after the commencement of this section.

Biologicals currently included in the Register

(2) If, immediately before the commencement of this section,

therapeutic goods that are a biological were included in the

biological on and after that commencement until the time the

biological is included in the Register under Part 3-2A.

Note: Section 32DN deals with including the biological under Part 3-2A.

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Part 4-1 Introduction

Division 3 Application provisions

Section 41BJA

264 Therapeutic Goods Act 1989

Pending applications

(3) If:

(a) before the commencement of this section, an application was

made under this Chapter for the inclusion in the Register of

therapeutic goods that are a biological; and

(b) immediately before that commencement, the application was

not finally determined; and

commencement;

this Chapter continues to apply to the biological on and after that

commencement until the earliest of the following:

(d) the time the biological is included in the Register under

Part 3-2A;

(e) if the application is unsuccessful when it is finally

determined—the time the application is finally determined;

(f) the time the application is withdrawn;

(g) the time the application lapses.

Note: Section 32DN deals with including the biological under Part 3-2A.

(4) For the purposes of this section, an application is finally

determined when the application, and any applications for review

or appeals arising out of it, have been finally determined or

otherwise disposed of.

Transitional

(5) This Chapter applies to a biological on and after the

commencement of this section in relation to things done, or

omitted to be done, in relation to the biological before the

commencement of this section.

(6) If this Chapter continues to apply to a biological during a period

described in subsection (2) or (3), then this Chapter also applies to

the biological after the end of that period in relation to things done,

or omitted to be done, in relation to the biological during that

period.

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Application provisions Division 3

Section 41BK

Therapeutic Goods Act 1989 265

41BK Application of the Criminal Code

Chapter 2 of the Criminal Code applies to all offences against this

Chapter.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

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Chapter 4 Medical devices

Part 4-2 Essential principles and medical device standards

Section 41C

266 Therapeutic Goods Act 1989

Part 4-2—Essential principles and medical device

standards

41C What this Part is about

The essential principles set out the requirements relating to the

safety and performance characteristics of medical devices.

Compliance with applicable medical device standards is not

required, but it is one way to establish compliance with essential

principles.

Note: Dealing in medical devices that do not comply with the essential principles may be an offence or may contravene a civil penalty provision: see Division 1 of Part 4-11.

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Essential principles Division 1

Section 41CA

Therapeutic Goods Act 1989 267

Division 1—Essential principles

41CA Essential principles

(1) The regulations may set out requirements for medical devices.

(2) These requirements are to be known as the essential principles.

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Chapter 4 Medical devices

Part 4-2 Essential principles and medical device standards

Division 2 Medical device standards

Section 41CB

268 Therapeutic Goods Act 1989

Division 2—Medical device standards

41CB Medical device standards

(1) The Minister may, by legislative instrument, make an order

determining that:

(a) matters specified in the order constitute a medical device

standard for kinds of medical devices identified in the order;

and

(b) medical devices of those kinds that comply with the standard

are to be treated as complying with those parts of the

essential principles specified in the standard.

Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

(2) The Minister may, by legislative instrument, vary or revoke an

order made under subsection (1).

41CC Content of medical device standards

(1) Without limiting the scope of section 41CB, an order establishing a

medical device standard for kinds of medical devices may be

specified by reference to:

(a) the safety or performance characteristics of the devices; or

(b) a monograph in the British Pharmacopoeia, the European

Pharmacopoeia or the United States Pharmacopeia-National

Formulary; or

the purposes of this subsection; or

(d) such a monograph as modified in a manner specified in the

order; or

(e) a standard published by a standards organisation; or

(f) such other matters as the Minister thinks fit.

(2) For the purposes of paragraph (1)(e), these are standards

organisations:

(a) Standards Australia;

(b) the International Organisation for Standardization;

(d) the European Committee for Standardization;

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Medical device standards Division 2

Section 41CD

Therapeutic Goods Act 1989 269

(e) the European Committee for Electrotechnical

Standardization;

(f) any other organisation declared by the Minister by notice

published in the Gazette.

41CD Inconsistencies between medical device standards

(1) A medical device standard that:

(a) applies to a kind of medical device; and

(b) is inconsistent with another medical device standard that

applies only to some of the devices of that kind;

is, to the extent of the inconsistency, of no effect in relation to the

devices referred to in paragraph (b).

(2) A medical device standard that applies to a kind of medical device

that consists of a combination of component parts takes precedence

over any medical device standard that applies to the component

parts.

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Chapter 4 Medical devices

Part 4-3 Conformity assessment procedures

Section 41D

270 Therapeutic Goods Act 1989

Part 4-3—Conformity assessment procedures

41D What this Part is about

The conformity assessment procedures set out the requirements

relating to the application of quality management systems for

medical devices, and other requirements imposed on

manufacturers.

Compliance with applicable conformity assessment standards is

not required, but it is one way to establish that one or more parts of

the conformity assessment procedures have been applied to

medical devices.

Note 1: Dealing in medical devices that have not had the conformity assessment procedures applied may be an offence or may contravene a civil penalty provision: see Division 2 of Part 4-11.

Note 2: See section 41BI on applying the conformity assessment procedures.

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Conformity assessment procedures Division 1

Section 41DA

Therapeutic Goods Act 1989 271

Division 1—Conformity assessment procedures

41DA Conformity assessment procedures

(1) The regulations may set out requirements relating to the

obligations of manufacturers of medical devices.

(2) These requirements are to be known as the conformity assessment

procedures.

(3) The conformity assessment procedures, or any part of the

conformity assessment procedures, may:

(a) be limited in their application to one or more medical device

classifications; or

(b) apply differently to different medical device classifications,

different kinds of medical devices or different manufacturers.

(4) Without limiting subsection (1), the regulations may relate to all or

any of the following:

(a) application of quality management systems for the

manufacture of medical devices;

(b) certification of compliance with the essential principles, or

the quality management systems for the manufacture of

medical devices;

manufacturer’s product range, product design or quality

management systems;

(d) declarations to be made by manufacturers of medical devices

that conformity assessment procedures have been applied to

the devices;

(e) marks to be affixed to medical devices indicating the

application of the conformity assessment procedures to the

devices;

(f) monitoring and inspecting the design of medical devices or

the manufacturing processes for medical devices;

(g) monitoring the performance of medical devices;

(h) corrective action required in relation to the design,

manufacture, packaging, labelling and supply of medical

devices;

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Part 4-3 Conformity assessment procedures

Division 1 Conformity assessment procedures

Section 41DB

272 Therapeutic Goods Act 1989

(i) keeping records of the manufacture of medical devices, the

design of medical devices or the manufacturing processes for

medical devices.

41DB Medical device classifications

The regulations may specify:

(a) classifications, to be known as medical device

classifications, applying to medical devices or kinds of

medical devices; and

(b) matters in relation to the classification of medical devices or

kinds of medical devices.

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Conformity assessment standards Division 2

Section 41DC

Therapeutic Goods Act 1989 273

Division 2—Conformity assessment standards

41DC Conformity assessment standards

(1) The Minister may, by legislative instrument, make an order

determining that:

(a) matters specified in the order constitute a conformity

assessment standard for quality management systems

identified in the order; and

(b) a quality management system that complies with the standard

is to be treated as having had applied to it those parts of the

conformity assessment procedures specified in the standard.

Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

(2) A conformity assessment standard may be limited to particular

kinds of medical devices.

(3) The Minister may, by legislative instrument, vary or revoke an

order made under subsection (1).

41DD Content of conformity assessment standards

(1) Without limiting the scope of section 41DC, an order establishing a

conformity assessment standard for a kind of medical device may

be specified by reference to:

(a) procedures to be carried out under the quality management

systems for the design, manufacture and final inspection of

the devices; or

(b) a standard published by a standards organisation; or

(2) For the purposes of paragraph (1)(b), these are standards

organisations:

(a) Standards Australia;

(b) the International Organisation for Standardization;

(d) any other organisation declared by the Minister by notice

published in the Gazette.

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Part 4-3 Conformity assessment procedures

Division 2 Conformity assessment standards

Section 41DE

274 Therapeutic Goods Act 1989

41DE Inconsistencies between conformity assessment standards

A conformity assessment standard that:

(a) identifies quality management systems to which it applies;

and

(b) is inconsistent with another conformity assessment standard

that applies only to particular kinds of medical devices;

is, to the extent of the inconsistency, of no effect in relation to the

devices referred to in paragraph (b).

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Conformity assessment certificates Part 4-4

Section 41E

Therapeutic Goods Act 1989 275

Part 4-4—Conformity assessment certificates

41E What this Part is about

The Secretary can issue a conformity assessment certificate (which

may be limited to some medical devices) in respect of a

manufacturer of medical devices, signifying one or more of these:

(a) that relevant quality management systems have

been applied to the device;

(b) the essential principles for the device have been

complied with;

assessment procedures have been met.

Note: A conformity assessment certificate may be required before a valid application can be made for including a kind of medical device in the Register under this Chapter: see subsection 41FC(2).

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Part 4-4 Conformity assessment certificates

Division 1 Issuing conformity assessment certificates

Section 41EA

276 Therapeutic Goods Act 1989

Division 1—Issuing conformity assessment certificates

41EA When conformity assessment certificates are required

The regulations may prescribe:

(a) kinds of manufacturers in respect of whom a conformity

assessment certificate must be issued before valid

applications can be made for kinds of medical devices,

manufactured by those manufacturers, to be included in the

(b) kinds of medical devices in respect of which a conformity

assessment certificate must be issued before valid

applications can be made for those kinds of medical devices

to be included in the Register.

Note: The regulations may prescribe different levels of fees for different kinds of manufacturers and medical devices: see subsection 41LA(2).

41EB Applications

(1) An application for a conformity assessment certificate must:

(a) be made in accordance with a form approved, in writing, by

the Secretary or in such other manner as is approved, in

writing, by the Secretary; and

(b) be delivered to an office of the Department specified by the

Secretary.

Note: A conformity assessment fee is payable under section 41LA for consideration of the application.

(2) An application is not effective if:

(a) the prescribed application fee has not been paid; or

(b) the application contains information that is false or

misleading in a material particular.

Note: A person might also commit an offence, or contravene a civil penalty provision, if the person makes a statement in an application that is false or misleading in a material particular: see sections 41EI and 41EIA.

(3) An approval of a form may require or permit an application or

information to be given in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

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Issuing conformity assessment certificates Division 1

Section 41EC

Therapeutic Goods Act 1989 277

(b) by way of a specified kind of electronic transmission.

(4) The Secretary may, by written notice given to an applicant for a

conformity assessment certificate, require the applicant to allow an

authorised person, at any reasonable time specified in the notice, to

inspect:

(a) the premises (including premises outside Australia) and

equipment, processes and facilities that are being or will be

used to manufacture medical devices of the kind in question;

and

(b) any other kinds of medical devices on those premises.

41EC Considering applications

(1) If the application is made in accordance with section 41EB, the

Secretary must decide whether to issue the conformity assessment

certificate.

(2) In deciding whether to issue the certificate, the Secretary must

consider some or all aspects of whether the conformity assessment

procedures relating to one or more of the following have been

applied to the medical device:

(a) the application of quality management systems for the

manufacture of medical devices;

(b) the certification of compliance with the essential principles;

procedures specified in regulations made for the purposes of

this subsection.

(3) In deciding whether to issue the certificate, the Secretary must also

consider:

(a) whether at least one of the following persons:

(i) the applicant;

(ii) a person (a manager) who makes, or participates in

making, decisions that affect the whole, or a substantial

part, of the applicant’s affairs;

(iii) if the applicant is a body corporate—a major interest

holder of the body corporate;

has, within the 10 years immediately before the application:

(iv) been convicted of an offence against this Act or a

corresponding State law; or

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Division 1 Issuing conformity assessment certificates

Section 41ED

278 Therapeutic Goods Act 1989

(v) been convicted of an offence against a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(vi) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of this Act or

a corresponding State law; or

(vii) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(viii) breached a condition of a conformity assessment

certificate; or

(ix) had a conformity assessment certificate suspended or

revoked; or

(x) been a manager, or a major interest holder, of a body

corporate in respect of which subparagraph (iv), (v),

(vi), (vii), (viii) or (ix) applies in that 10 year period, if

the conduct resulting in that subparagraph applying

occurred when the person was a manager or major

interest holder of the body corporate; or

(b) whether any other circumstances prescribed by the

regulations for the purposes of this paragraph exist.

(4) A reference in paragraph (3)(a) to a person convicted of an offence

includes a reference to a person in respect of whom an order has

been made relating to the offence under:

(a) section 19B of the Crimes Act 1914; or

(b) a corresponding provision of a law of a State or Territory.

Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

(5) Paragraph (3)(a) does not limit paragraph (3)(b).

41ED Time for making decisions on applications

If the application relates to the issuing of a conformity assessment

certificate in relation to which a period has been prescribed under

paragraph 63(2)(dc), a decision on the application must be made

within that period, unless the application lapses under

section 41EG.

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Issuing conformity assessment certificates Division 1

Section 41EE

Therapeutic Goods Act 1989 279

41EE Procedure following making a decision whether to issue

certificate

(1) After making a decision whether to issue a conformity assessment

certificate, the Secretary must:

(a) notify the applicant in writing of his or her decision within 20

working days; and

(b) if the decision is not to issue the certificate—state in the

notice the reasons for the decision; and

fees that are due and payable for the application have been

paid:

(i) issue the certificate to the manufacturer in relation to

whom the application was made; and

(ii) give the applicant a copy of the certificate (if the

applicant is not the manufacturer).

(2) A conformity assessment certificate must specify whether it

covers:

(a) all medical devices manufactured by the manufacturer; or

(b) only specified medical devices manufactured by the

manufacturer.

41EF Duration of certificate

(1) The conformity assessment certificate commences on the day

specified for the purpose in the certificate.

(2) A conformity assessment certificate has effect at all times:

(a) unless the certificate is suspended under Division 3; or

(b) until the end of the period (if any) specified in the certificate;

41EG Lapsing of applications

An application for a conformity assessment certificate lapses if:

(a) the applicant does not deliver to the office to which the

application was made such information (in a form approved

in writing by the Secretary) as will allow the certificate to be

issued; or

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Part 4-4 Conformity assessment certificates

Division 1 Issuing conformity assessment certificates

Section 41EH

280 Therapeutic Goods Act 1989

(b) the applicant does not comply with a requirement by the

Secretary to deliver to the office to which the application was

made a reasonable number of samples of the kind of medical

device to which the application relates; or

section 41JA to give to the Secretary information within a

further 10 working days from the day specified in the notice;

(d) information given to the Secretary by, or on behalf of, the

applicant in connection with the application, including

information given for the purpose of a notice under

section 41JA, is false or misleading in a material particular;

(e) the applicant fails to allow an authorised person to carry out

any inspection as required under subsection 41EB(4); or

(f) for the whole or a part of the conformity assessment fee for

the application that is due and payable in accordance with

regulations made for the purposes of Part 4-10—the applicant

fails to pay that whole or part in accordance with those

regulations.

41EH Treating applications as having been refused

(1) The applicant for an application for a conformity assessment

certificate may give the Secretary written notice that the applicant

wishes to treat the application as having been refused if:

(a) a period is prescribed under paragraph 63(2)(dc) for making

a decision on the application; and

(b) at the end of the period, the applicant has not been notified of

a decision whether to issue the certificate.

(2) The notice may be given at any time before the applicant is notified

of the decision.

(3) If a notice has been given, this Act (except for subsection 60(5)) has

effect as if:

(a) the Secretary had decided not to issue the certificate; and

(b) the Minister had made a decision under subsection 60(3)

confirming the decision of the Secretary; and

notice was given to the Secretary.

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Issuing conformity assessment certificates Division 1

Section 41EI

Therapeutic Goods Act 1989 281

41EI Criminal offences for making a false statement

(1) A person commits an offence if:

(a) the person makes a statement (whether orally, in a document

or in any other way); and

(b) the statement is made in or in connection with an application

for a conformity assessment certificate; and

a material particular; and

(d) either:

(i) the use of the kind of medical device has resulted in, or

will result in, harm or injury to any person; or

(ii) the use of the kind of medical device, if the kind of

medical device were used, would result in harm or

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person makes a statement (whether orally, in a document

or in any other way); and

(b) the statement is in or in connection with an application for a

conformity assessment certificate; and

and

(d) the use of the kind of medical device, if the kind of medical

device were used, would be likely to result in harm or injury

to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

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Part 4-4 Conformity assessment certificates

Division 1 Issuing conformity assessment certificates

Section 41EIA

282 Therapeutic Goods Act 1989

(a) the person makes a statement (whether orally, in a document

or in any other way); and

(b) the statement is in or in connection with an application for a

conformity assessment certificate; and

a material particular.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

41EIA Civil penalty for making a false statement

A person contravenes this section if:

(a) the person makes a statement (whether orally, in a document

or in any other way); and

(b) the statement is false or misleading in a material particular;

and

conformity assessment certificate.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

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Conditions Division 2

Section 41EJ

Therapeutic Goods Act 1989 283

Division 2—Conditions

Note: Breaching conditions of the conformity assessment certificate may lead to suspension or revocation of the certificate (see Divisions 3 and 4), may be an offence (see subsections 41MN(5), (6) and (8)), and may contravene a civil penalty provision (see subsection 41MNA(2)).

41EJ Automatic conditions on conformity assessment certificates

Entry and inspection powers

(1) A conformity assessment certificate is subject to the conditions that

the manufacturer in respect of whom the certificate is issued will:

(a) allow an authorised person:

(i) to enter, at any reasonable time, premises (including

premises outside Australia) at which the person or any

other person deals with medical devices of a kind

covered by the certificate; and

(ii) while on those premises, to inspect those premises and

medical devices of any kind on those premises and to

examine, take measurements of, conduct tests on,

require tests to be conducted on or take samples of

medical devices of any kind on those premises or any

thing on those premises that relates to medical devices

of any kind; and

(iii) while on those premises, to make any still or moving

image or any recording of those premises or any thing

on those premises; and

(b) if requested to do so by an authorised person:

(i) produce to the person such documents relating to

devices of a kind covered by the certificate, or to the

manufacturer’s quality management system, as the

person requires; and

(ii) allow the person to copy the documents.

Review

(2) A conformity assessment certificate is subject to the condition that

the manufacturer in respect of whom the certificate is issued will

cooperate in any review by the Secretary of the certificate to

determine whether the conformity assessment procedures relating

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Chapter 4 Medical devices

Part 4-4 Conformity assessment certificates

Division 2 Conditions

Section 41EJ

284 Therapeutic Goods Act 1989

to the following matters have been applied to the kinds of medical

devices covered by the certificate:

(a) the application of quality management systems for the

manufacture of medical devices;

(b) the certification of compliance with the essential principles;

procedures specified in the regulations made for the purposes

of subsection 41EC(2).

Notification of substantial changes

(3) A conformity assessment certificate is subject to the condition that

the person in respect of whom the certificate is issued will notify

the Secretary, in writing, of any plan for substantial changes to:

(a) quality management systems; or

(b) the product range covered by those systems; or

in respect of which the certificate is issued.

Fees

(4) A conformity assessment certificate is subject to the condition that

the applicant for the certificate will pay a fee, prescribed in the

regulations, for a review under subsection (2), when the fee

becomes due and payable.

(5) The regulations may prescribe different levels of fees for different

kinds of manufacturers and medical devices.

Conditions in regulations

(5A) A conformity assessment certificate is subject to any conditions

prescribed by the regulations for the purposes of this subsection.

Conditions do not limit other conditions

(6) A condition imposed under this section is in addition to any

conditions imposed under this Division.

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Medical devices Chapter 4

Conformity assessment certificates Part 4-4

Conditions Division 2

Section 41EK

Therapeutic Goods Act 1989 285

41EK Conditions imposed when conformity assessment certificates

are issued

If the Secretary issues a conformity assessment certificate in

respect of a manufacturer, the Secretary may, in writing, impose

conditions on the certificate in respect of:

(a) one or more kinds of medical devices covered by the

certificate; or

(b) the manufacturer’s quality management system.

41EL Conditions imposed after issuing a conformity assessment

certificate

(1) The Secretary may, by written notice given to a manufacturer in

respect of whom a conformity assessment certificate has been

issued:

(a) impose new conditions on the certificate in respect of:

(i) one or more kinds of medical devices covered by the

certificate; or

(ii) the manufacturer’s quality management system; or

(b) vary or remove existing conditions.

The power may be exercised at the request of the applicant for the

certificate or on the Secretary’s own initiative.

(2) The imposition or variation of a condition under this section takes

effect:

(a) if the notice states that the action is necessary to prevent

imminent risk of death, serious illness or serious injury—on

the day on which the notice is given to the person; or

(b) in any other case—on the day specified for the purpose in the

notice, being a day not earlier than 20 working days after the

notice is given to the person.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-4 Conformity assessment certificates

Division 3 Suspension of conformity assessment certificates

Section 41EM

286 Therapeutic Goods Act 1989

Division 3—Suspension of conformity assessment

certificates

Note: Suspension of a conformity assessment certificate leads to suspension from the Register of the kinds of medical devices to which the certificate applied (see subsection 41GF(1)). Applications to include such devices in the Register are not effective (see paragraph 41FC(2)(c)).

41EM Suspension of conformity assessment certificates

(1) The Secretary may, by written notice given to the person in relation

to whom a conformity assessment certificate is issued, suspend the

certificate if the Secretary is satisfied that it is likely that there are

grounds for revoking the certificate under section 41ET.

(2) The suspension may be limited to some medical devices of that

kind, as specified in the notice.

(3) The notice must specify the period of the suspension. The period

must not exceed 6 months.

Note: The period of the suspension may be extended under section 41EO.

41EN Notice of proposed suspension

(1) However, before suspending a conformity assessment certificate,

the Secretary must:

(a) inform the person in writing that the Secretary proposes the

suspension and set out the reasons for it; and

(b) give the person a reasonable opportunity to make

submissions to the Secretary in relation to the proposed

suspension.

(2) The Secretary is not to make a decision relating to the proposed

suspension until the Secretary has had regard to any submissions

the person makes under paragraph (1)(b).

(3) This section does not apply if the notice under section 41EM states

that the suspension is necessary to prevent imminent risk of death,

serious illness or serious injury.

41EO Duration of suspension

(1) The suspension takes effect:

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Medical devices Chapter 4

Conformity assessment certificates Part 4-4

Suspension of conformity assessment certificates Division 3

Section 41EP

Therapeutic Goods Act 1989 287

(a) if the notice under section 41EM states that the suspension is

necessary to prevent imminent risk of death, serious illness or

serious injury—on the day on which the notice is given to the

person; or

(b) in any other case—on the day specified for the purpose in the

notice, being a day not earlier than 20 working days after the

notice is given to the person.

(2) The suspension has effect until:

(a) the Secretary revokes it under section 41EP; or

(b) the expiry of:

(i) the period specified in the notice under section 41EM;

(ii) if the period is extended under subsection (3) of this

section, the period as so extended.

Note: Unless a suspension of a conformity assessment certificate has been revoked, the certificate is automatically revoked: see section 41ER.

(3) If a person in relation to whom a kind of medical device is

included in the Register shows that he or she has taken steps to

address the grounds for revoking the certificate under

section 41ET, the Secretary may, by written notice given to the

person, extend the period specified in the notice under

section 41EM by a further specified period not exceeding 6

months.

41EP Revocation of suspension

(1) The Secretary must revoke the suspension if the Secretary is

satisfied that:

(a) the ground on which the conformity assessment certificate

was suspended no longer applies; and

(b) there are no other grounds for suspending the certificate.

(2) The Secretary’s power to revoke the suspension may be exercised:

(a) if:

(i) the manufacturer in relation to whom the conformity

assessment certificate was issued; or

(ii) the person who applied for the certificate (if the

applicant was not the manufacturer);

applies in writing to the Secretary; or

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-4 Conformity assessment certificates

Division 3 Suspension of conformity assessment certificates

Section 41EQ

288 Therapeutic Goods Act 1989

(b) on the Secretary’s own initiative.

(3) After revoking the suspension, the Secretary must, within 20

working days after the revocation, give written notice of the

revocation to the person in relation to whom the conformity

assessment certificate was issued.

(4) If the Secretary decides, after an application is made under

paragraph (2)(a), not to revoke the suspension, the Secretary must:

(a) notify the applicant in writing of his or her decision within 20

working days after the decision is made; and

(b) state in the notice the reasons for the decision.

41EQ Powers of revocation of conformity assessment certificates

unaffected

(1) This Division does not affect the Secretary’s powers to revoke a

conformity assessment certificate under Division 4.

(2) To the extent that a suspension under this Division relates to a

conformity assessment certificate to which such a revocation

relates, the suspension ceases to have effect.

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Conformity assessment certificates Part 4-4

Revocation of conformity assessment certificates Division 4

Section 41ER

Therapeutic Goods Act 1989 289

Division 4—Revocation of conformity assessment

certificates

Note: Revocation of a conformity assessment certificate leads to cancellation of the entry from the Register of the kinds of medical devices to which the certificate applied (see paragraph 41GK(b)). Applications to include such devices in the Register are not effective (see paragraph 41FC(2)(c)).

41ER Automatic revocation of conformity assessment certificates

The Secretary must, by written notice given to the person in

relation to whom a conformity assessment certificate is issued,

revoke the certificate if:

(a) the certificate has been suspended under section 41EM; and

(b) the period applying to the suspension under

subsection 41EM(3) or 41EO(3) (as the case requires)

expires before the suspension is revoked under section 41EP.

41ES Immediate revocation of conformity assessment certificates

The Secretary may, by written notice given to the manufacturer in

relation to whom a conformity assessment certificate is issued,

revoke the certificate if the manufacturer requests in writing the

revocation of the certificate.

41ET Revocation of conformity assessment certificates after notice

of proposed revocation

(1) The Secretary may, by written notice given to the person in relation

to whom a conformity assessment certificate is issued, revoke the

certificate if:

(a) the conformity assessment procedures have not been applied

to medical devices of a kind to which the certificate applies;

(b) the manufacturer in relation to whom the certificate is issued

refuses or fails to comply with a condition to which the

certificate is subject; or

that requires the person to give to the Secretary information

or documents and the person fails to comply with that notice

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Chapter 4 Medical devices

Part 4-4 Conformity assessment certificates

Division 4 Revocation of conformity assessment certificates

Section 41ET

290 Therapeutic Goods Act 1989

within a further 10 working days from the day specified in

that notice; or

(d) the manufacturer in respect of whom the certificate is issued

no longer manufactures any of the kinds of medical devices

to which the certificate applies; or

(e) at least one of the following persons:

(i) the person (the holder) in relation to whom the

certificate is issued;

(ii) a person (a manager) who makes, or participates in

making, decisions that affect the whole, or a substantial

part, of the holder’s affairs;

(iii) if the holder is a body corporate—a major interest

holder of the body corporate;

has:

(iv) been convicted of an offence against this Act or a

corresponding State law; or

(v) been convicted of an offence against a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(vi) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of this Act or

a corresponding State law; or

(vii) been ordered to pay a pecuniary penalty for the

contravention of a civil penalty provision of a law of the

Commonwealth or a law of a State or Territory

involving fraud or dishonesty; or

(viii) breached a condition of a conformity assessment

certificate; or

(ix) had a conformity assessment certificate suspended or

revoked; or

(x) been a manager, or a major interest holder, of a body

corporate in respect of which subparagraph (iv), (v),

(vi), (vii), (viii) or (ix) applies, if the conduct resulting

in that subparagraph applying occurred when the person

was a manager or major interest holder of the body

corporate; or

(f) any other circumstances prescribed by the regulations for the

purposes of this paragraph exist.

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Conformity assessment certificates Part 4-4

Revocation of conformity assessment certificates Division 4

Section 41EU

Therapeutic Goods Act 1989 291

(1A) A reference in paragraph (1)(e) to a person convicted of an offence

includes a reference to a person in respect of whom an order has

been made relating to the offence under:

(a) section 19B of the Crimes Act 1914; or

(b) a corresponding provision of a law of a State or Territory.

Note: Section 19B of the Crimes Act 1914 empowers a court that has found a person to have committed an offence to take action without proceeding to record a conviction.

(1B) Paragraph (1)(e) does not limit paragraph (1)(f).

(2) However, before revoking the certificate, the Secretary must:

(a) inform the person in writing that the Secretary proposes the

revocation and set out the reasons for it; and

(b) give the person a reasonable opportunity to make

submissions to the Secretary in relation to the proposed

revocation.

(3) The Secretary is not to make a decision relating to the proposed

revocation until the Secretary has had regard to any submissions

the person makes under paragraph (2)(b).

(4) Nothing in this section affects the operation of Part VIIC of the

Crimes Act 1914 (which includes provisions that, in certain

circumstances, relieve persons from the requirement to disclose

spent convictions and require persons aware of such convictions to

disregard them).

41EU Limiting revocation of conformity assessment certificates to

some medical devices of a particular kind

(1) If the Secretary is satisfied that the ground for revoking a

conformity assessment certificate applies only to:

(a) some of the kinds of medical devices to which the certificate

applies; or

(b) some medical devices of the kinds to which the certificate

applies;

the Secretary must limit the revocation to the medical devices to

which that ground or any other ground for revocation applies.

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Chapter 4 Medical devices

Part 4-4 Conformity assessment certificates

Division 4 Revocation of conformity assessment certificates

Section 41EV

292 Therapeutic Goods Act 1989

(2) If the revocation of the certificate is so limited, the Secretary must

vary the certificate so that it no longer applies to the medical

devices referred to in subsection (1).

41EV Publication of revocation etc. of conformity assessment

certificates

The Secretary must cause to be published in the Gazette, as soon as

practicable after revoking a conformity assessment certificate, or

varying a conformity assessment certificate under

subsection 41EU(2), a notice setting out particulars of the

revocation or variation.

41EW Date of effect of revocation etc. of conformity assessment

certificates

If the Secretary revokes a conformity assessment certificate, or

varies a conformity assessment certificate under

subsection 41EU(2), the revocation or variation has effect:

(a) if the revocation is under section 41ER or 41ES, or the

variation relates to a ground of revocation in section 41ER or

41ES—on the day on which the notice of revocation or

variation is given to the person in relation to whom the

certificate was issued; or

(b) in any other case—on such later day as is specified in the

notice.

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Medical devices Chapter 4

Including medical devices in the Register Part 4-5

Section 41F

Therapeutic Goods Act 1989 293

Part 4-5—Including medical devices in the Register

41F What this Part is about

Kinds of medical devices can be included in the Register if they

comply with the essential principles, and conformity assessment

procedures have been applied to the kinds of devices (and certain

other requirements are complied with).

Inclusions in the Register are subject to certain automatic

conditions and the Secretary may impose further conditions.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-5 Including medical devices in the Register

Division 1 Including medical devices in the Register

Section 41FA

294 Therapeutic Goods Act 1989

Division 1—Including medical devices in the Register

41FA What this Division is about

Kinds of medical devices are usually included in the Register

automatically once a proper application is made, together with the

required certification. However, applications may be selected for

audit, which involves checking some or all aspects of the

application and certification.

Note 1: In some cases, an application relating to a kind of medical device will not be effective unless that kind of device is covered by a conformity assessment certificate under Part 4-4: see paragraph 41FC(2)(c).

Note 2: Dealing in medical devices of a kind not included in the Register may be an offence or may contravene a civil penalty provision: see Division 3 of Part 4-11.

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Including medical devices in the Register Part 4-5

Including medical devices in the Register Division 1

Section 41FB

Therapeutic Goods Act 1989 295

41FB How this Division works

This diagram shows how this Division applies to an application for

a kind of medical device to be included in the Register.

Does the application comply with

Subdivision A?

Has the application been selected

for audit under Subdivision C?

Is the Secretary satisfied as to all

matters considered in the audit?

The Secretary will include

the kind of medical device

in the Register

The Secretary will refuse

the application

Yes

Yes No

Subdivision A—Applications

41FC Applications

(1) An application for a kind of medical device to be included in the

(a) be made in accordance with a form approved, in writing, by

the Secretary or in such other manner as is approved, in

writing, by the Secretary; and

(b) be delivered to an office of the Department specified by the

Secretary.

(2) An application is not effective if:

(a) the application is not made in accordance with

subsection (1); or

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Chapter 4 Medical devices

Part 4-5 Including medical devices in the Register

Division 1 Including medical devices in the Register

Section 41FD

296 Therapeutic Goods Act 1989

(b) the prescribed application fee has not been paid; or

the manufacturer of the kind of device to have a conformity

assessment certificate relating to the kind of medical device

before an application under this section can be made, and no

such certificate is in force; or

(d) the application contains information that is false or

misleading in a material particular.

(3) An approval of a form may require or permit an application or

information to be given in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

41FD Matters to be certified

The applicant must certify that:

(a) devices of the kind in question are medical devices; and

(b) devices of that kind are intended for a specified purpose, as

ascertained under subsection 41BD(2); and

medical device classifications; and

(d) devices of that kind comply with the essential principles; and

(e) the applicant:

(i) has available sufficient information to substantiate that

compliance with the essential principles; or

(ii) has procedures in place, including a written agreement

with the manufacturer of the kind of devices setting out

the matters required by the regulations, to ensure that

such information can be obtained from the manufacturer

within the period specified in the regulations; and

(f) an appropriate conformity assessment procedure has been

applied to devices of that kind; and

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Medical devices Chapter 4

Including medical devices in the Register Part 4-5

Including medical devices in the Register Division 1

Section 41FE

Therapeutic Goods Act 1989 297

(g) the applicant:

(i) has available sufficient information to substantiate the

application of those conformity assessment procedures;

(ii) has procedures in place, including a written agreement

with the manufacturer of the kind of devices setting out

the matters required by the regulations, to ensure that

such information can be obtained from the manufacturer

within the period specified in the regulations; and

(h) devices of that kind comply with every requirement (if any)

relating to advertising applicable under Part 5-1 or under the

regulations; and

(i) devices of that kind do not contain substances that are

prohibited imports for the purposes of the Customs Act 1901;

and

(ia) devices of that kind are not to be used exclusively for one or

more of the purposes specified under section 41BEA; and

(j) the information included in or with the application is

complete and correct.

Note: See section 41BH on compliance with the essential principles and section 41BI on applying the conformity assessment procedures.

41FE Criminal offences for making a false statement

(1) A person commits an offence if:

(a) the person makes a statement (whether orally, in a document

or in any other way); and

(b) the person knows that the statement is false or misleading in

a material particular; and

(i) an application for including a kind of medical device in

the Register under this Chapter; or

(ii) a certification or purported certification under

section 41FD; and

(d) either:

(i) the use of the kind of medical device has resulted in, or

will result in, harm or injury to any person; or

(ii) the use of the kind of medical device, if the kind of

medical device were used, would result in harm or

injury to any person.

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Chapter 4 Medical devices

Part 4-5 Including medical devices in the Register

Division 1 Including medical devices in the Register

Section 41FE

298 Therapeutic Goods Act 1989

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person makes a statement (whether orally, in a document

or in any other way); and

(b) the statement is false or misleading in a material particular;

and

(i) an application for including a kind of medical device in

the Register under this Chapter; or

(ii) a certification or purported certification under

section 41FD; and

(d) the use of the kind of medical device, if the kind of medical

device were used, would be likely to result in harm or injury

to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person makes a statement (whether orally, in a document

or in any other way); and

(b) the person knows that the statement is false or misleading in

a material particular; and

(i) an application for including a kind of medical device in

the Register under this Chapter; or

(ii) a certification or purported certification under

section 41FD.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Including medical devices in the Register Part 4-5

Including medical devices in the Register Division 1

Section 41FEA

Therapeutic Goods Act 1989 299

41FEA Civil penalty for making a false statement

A person contravenes this section if:

(a) the person makes a statement (whether orally, in a document

or in any other way); and

(b) the statement is false or misleading in a material particular;

and

(i) an application for including a kind of medical device in

the Register under this Chapter; or

(ii) a certification or purported certification under

section 41FD.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Subdivision B—Including kinds of medical devices in the

Register

41FF Obligation to include kinds of medical devices in the Register

(1) If:

(a) an application is made in accordance with section 41FC for a

kind of medical device to be included in the Register in

relation to a person; and

(b) the requirements of section 41FD have been complied with;

the Secretary must include the kind of device in the Register in

relation to the person, unless the application has been selected

under section 41FH for audit.

(1A) However, the Secretary must not include the kind of device in the

the kind of device is to be used exclusively for one or more of the

purposes specified under section 41BEA.

(2) As soon as practicable after the kind of device has been included in

the Register, the Secretary must give to the applicant a certificate

of the inclusion of the kind of device in the Register.

(3) The certificate must specify the day on which the inclusion of the

kind of device in the Register commences.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-5 Including medical devices in the Register

Division 1 Including medical devices in the Register

Section 41FG

300 Therapeutic Goods Act 1989

41FG Notification of unsuccessful applications

The Secretary must notify the applicant in writing, within 20

working days after receiving an application under

subsection 41FC(1), if an application for a kind of medical device

to be included in the Register is unsuccessful.

Subdivision C—Auditing of applications

41FH Selecting applications for auditing

(1) The Secretary:

(a) must select for auditing any application for a kind of medical

device to be included in the Register that is an application of

the kind prescribed by the regulations; and

(b) may select for auditing any other application for a kind of

medical device to be included in the Register.

Note: An application audit assessment fee is payable in respect of any application that the Secretary must select for auditing: see Part 4-10.

(2) If an application is selected for auditing:

(a) the Secretary must, within 20 working days after the

application is made, give the applicant a written notice that:

(i) informs the applicant of the selection; and

(ii) requests the applicant to provide any further information

necessary for the auditing of the application; and

(b) the application must be dealt with under this Subdivision and

not under Subdivision B.

41FI Auditing of applications

(1) In auditing the application, the Secretary may consider all or some

aspects of one or both of the following matters:

(a) whether the application is in accordance with Subdivision A;

(b) whether matters as to which the applicant has certified under

section 41FD are correct.

(2) The Secretary must decide to include the kind of device to which

the application relates in the Register, in relation to the person to

whom the application relates, if the Secretary is satisfied as to all

such aspects considered in the audit.

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Medical devices Chapter 4

Including medical devices in the Register Part 4-5

Including medical devices in the Register Division 1

Section 41FJ

Therapeutic Goods Act 1989 301

(3) The Secretary must decide not to include the kind of device to

which the application relates in the Register if the Secretary is not

so satisfied.

41FJ Procedure following audits

After auditing the application, the Secretary must:

(a) notify the applicant in writing of his or her decision within 20

working days after the decision is made; and

(b) if the decision is not to include the kind of device to which

the application relates in the Register—state in the notice the

reasons for the decision; and

and all assessment fees for the application that are due and

payable have been paid:

(i) include the kind of device in the Register, in relation to

the person in relation to whom the application was

made; and

(ii) give the applicant a certificate of the inclusion of the

kind of device in the Register.

41FK Lapsing of applications

An application that has been selected for auditing lapses if:

(a) the applicant does not deliver to the office to which the

application was made such information (in a form approved

in writing by the Secretary) as will allow the audit of the

application; or

(b) the applicant does not comply with a requirement by the

Secretary to deliver to the office to which the application was

made a reasonable number of samples of the kind of medical

device to which the application relates; or

section 41JA to give information relating to devices of that

kind to the Secretary within a further 10 working days from

the day specified in the notice; or

(d) information given to the Secretary by, or on behalf of, the

applicant in connection with the application, including

information given for the purpose of a requirement under

section 41JA, is false or misleading in a material particular;

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Chapter 4 Medical devices

Part 4-5 Including medical devices in the Register

Division 1 Including medical devices in the Register

Section 41FL

302 Therapeutic Goods Act 1989

(e) the applicant fails to pay an assessment fee for the

application in accordance with section 41LB or 41LC.

Subdivision D—Miscellaneous

41FL Device number

If a kind of medical device is included in the Register, the

Secretary is to assign a unique device number to it.

41FM Duration of inclusion in the Register

(1) The inclusion of a kind of medical device in the Register

commences on the day specified for the purpose in the certificate

under section 41FF.

(2) The inclusion of a kind of medical device in the Register has effect

at all times:

(a) unless the kind of device is suspended from the Register

under Division 1 of Part 4-6; or

(b) until entry of the kind of device is cancelled from the

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Medical devices Chapter 4

Including medical devices in the Register Part 4-5

Conditions Division 2

Section 41FN

Therapeutic Goods Act 1989 303

Division 2—Conditions

Note: Breaching conditions of the inclusion of a kind of medical device may lead to suspension or cancellation of the entry of the kind of device from the Register (see Part 4-6), may be an offence (see subsections 41MN(1), (2) and (4)), and may contravene a civil penalty provision (see subsection 41MNA(1)).

41FN Conditions applying automatically

Entry and inspection powers

(1) The inclusion of a kind of medical device in the Register is subject

to the conditions that the person in relation to whom the kind of

device is included in the Register:

(a) allow an authorised person:

(i) to enter, at any reasonable time, any premises (including

premises outside Australia) at which that person or any

other person deals with medical devices of that kind;

and

(ii) while on those premises, to inspect those premises and

medical devices of any kind on those premises and to

examine, take measurements of, conduct tests on,

require tests to be conducted on or take samples of

medical devices of any kind on those premises or any

thing on those premises that relates to medical devices

of any kind; and

(iii) while on those premises, to make any still or moving

image or any recording of those premises or any thing

on those premises; and

(b) if requested to do so by an authorised person, produce to the

person such documents relating to devices of the kind

included in the Register as the person requires and allow the

person to copy the documents.

Delivery of samples

(2) The inclusion of a kind of medical device in the Register is subject

to a condition that the person in relation to whom the kind of

device is included in the Register will deliver a reasonable number

of samples of the kind of device if the Secretary so requests:

(a) within the period specified in the request; and

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Chapter 4 Medical devices

Part 4-5 Including medical devices in the Register

Division 2 Conditions

Section 41FN

304 Therapeutic Goods Act 1989

(b) in accordance with any other requirements specified in the

request.

The period specified in the request must include at least 10

working days.

Availability etc. of information

(3) The inclusion of a kind of medical device in the Register is subject

to conditions that:

(a) at all times while the inclusion in the Register has effect, the

person in relation to whom the kind of device is included in

the Register:

(i) has available sufficient information to substantiate

compliance with the essential principles; or

(ii) has procedures in place, including a written agreement

with the manufacturer of the kind of devices setting out

the matters required by the regulations, to ensure that

such information can be obtained from the manufacturer

within the period specified in the regulations; and

(b) at all times while the inclusion in the Register has effect, the

person in relation to whom the kind of device is included in

the Register:

(i) has available sufficient information to substantiate that

the conformity assessment procedures have been

applied to the kind of medical device; or

(ii) has available information relating to changes to the kind

of medical device, the product range, and quality

management system, of the manufacturer of the device;

(iii) has procedures in place, including a written agreement

with the manufacturer of the kind of devices setting out

the matters required by the regulations, to ensure that

such information can be obtained from the manufacturer

within the period specified in the regulations; and

person in relation to whom the kind of device is included in

the Register will, if asked to do so by the Secretary, give the

information to the Secretary; and

(d) the person in relation to whom the kind of device is included

in the Register will give information of a kind mentioned in

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Medical devices Chapter 4

Including medical devices in the Register Part 4-5

Conditions Division 2

Section 41FO

Therapeutic Goods Act 1989 305

subsection 41MP(2) or 41MPA(2) to the Secretary within the

period specified in the regulations; and

(e) the person in relation to whom the kind of device is included

in the Register will give the manufacturer of the kind of

medical device information relevant to:

(i) the manufacturer’s obligations under the conformity

assessment procedures; and

(ii) whether medical devices of that kind comply with the

essential principles.

(4) The regulations may prescribe the amount, standard or kind of

information or evidence required for the purposes of

paragraphs (3)(c), (d) and (e).

Advertising material

(5) The inclusion of a kind of medical device in the Register is subject

to a condition that advertising material relating to medical devices

of that kind is consistent with the intended purpose as certified

under section 41FD.

Conditions do not limit other conditions

(6) A condition imposed under this section is in addition to any

conditions imposed under this Division.

41FO Conditions imposed when kinds of medical devices are

included in the Register

(1) If the Secretary includes a kind of medical device in the Register in

relation to a person, the Secretary may, in writing, impose

conditions on the inclusion of the kind of device in the Register.

(2) Conditions referred to in subsection (1) may relate to:

(a) manufacture of devices of that kind; or

(b) custody, intended purpose, supply, disposal or destruction of

devices of that kind; or

records relating to the tracking and location of devices of that

kind after their supply; or

(d) matters dealt with in, or matters additional to matters dealt

with in, the essential principles; or

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Chapter 4 Medical devices

Part 4-5 Including medical devices in the Register

Division 2 Conditions

Section 41FP

306 Therapeutic Goods Act 1989

(e) such other matters relating to devices of that kind as the

Secretary thinks appropriate.

41FP Conditions imposed after kinds of medical devices are

included in the Register

(1) The Secretary may, by written notice given to the person in relation

to whom a kind of medical device is included in the Register:

(a) impose new conditions on including the kind of device in the

(b) vary or remove existing conditions.

The power may be exercised at the person’s request or on the

Secretary’s own initiative.

(2) The imposition or variation of a condition under this section takes

effect:

(a) if the notice states that the action is necessary to prevent

imminent risk of death, serious illness or serious injury—on

the day on which the notice is given to the person; or

(b) in any other case—on the day specified for the purpose in the

notice, being a day not earlier than 20 working days after the

notice is given to the person.

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Medical devices Chapter 4

Suspension and cancellation from the Register Part 4-6

Suspension from the Register Division 1

Section 41G

Therapeutic Goods Act 1989 307

Part 4-6—Suspension and cancellation from the

Register

Division 1—Suspension from the Register

Subdivision A—General power of suspension

41G What this Part is about

Inclusions in the Register may be suspended in certain

circumstances, such as when a conformity assessment certificate is

suspended. A kind of medical device that is suspended is taken not

to be included in the Register for most purposes.

Inclusions in the Register may also be cancelled in certain

circumstances.

41GA Suspension of kinds of medical devices from the Register

(1) The Secretary may, by written notice given to the person in relation

to whom a kind of medical device is included in the Register,

suspend the kind of device from the Register if:

(a) the Secretary is satisfied that:

(i) there is a potential risk of death, serious illness or

serious injury if the kind of device continues to be

included in the Register; and

(ii) it is likely that the person will, within the period of the

suspension, be able to take the action necessary to

ensure that the kind of device would not cause a

potential risk of death, serious illness or serious injury if

it were to continue to be included in the Register; or

(b) the Secretary is satisfied that it is likely that there are grounds

for cancelling the entry of the kind of device from the

paragraph 41GL(a) or (d) or section 41GM).

(2) The suspension may be limited to some medical devices of that

kind, as specified in the notice.

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Chapter 4 Medical devices

Part 4-6 Suspension and cancellation from the Register

Division 1 Suspension from the Register

Section 41GB

308 Therapeutic Goods Act 1989

(3) The notice must specify the period of the suspension. The period

must not exceed 6 months.

Note: The period of the suspension may be extended under section 41GC.

(4) The Secretary must cause to be published in the Gazette, as soon as

practicable after the suspension, a notice setting out particulars of

the suspension.

41GB Notice of proposed suspension must be given in certain cases

(1) However, before suspending a kind of medical device from the

the entry of the kind of device from the Register under

section 41GN, the Secretary must:

(a) inform the person by written notice that the Secretary

proposes the suspension and set out the reasons for it; and

(b) give the person a reasonable opportunity to make

submissions to the Secretary in relation to the proposed

suspension.

(2) The Secretary is not to make a decision relating to the proposed

suspension until the Secretary has had regard to any submissions

the person makes under paragraph (1)(b).

41GC Duration of suspension

(1) The suspension takes effect:

(a) if the notice under subsection 41GA(1) states that the

suspension is necessary to prevent a potential risk of death,

serious illness or serious injury—on the day on which the

notice is given to the person; or

(b) in any other case—on the day specified for the purpose in the

notice, being a day not earlier than 20 working days after the

notice is given to the person.

(2) The suspension has effect until:

(a) the Secretary revokes it under section 41GD; or

(b) the end of:

(i) the period specified in the notice under

subsection 41GA(3); or

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Medical devices Chapter 4

Suspension and cancellation from the Register Part 4-6

Suspension from the Register Division 1

Section 41GD

Therapeutic Goods Act 1989 309

(ii) if the period is extended under subsection (3) of this

section, the period as so extended.

Note: Unless a suspension of a kind of medical device has been revoked, the entry of the kind of medical device is automatically cancelled from the Register: see section 41GK.

(3) If a person in relation to whom a kind of medical device is

included in the Register shows that he or she has taken steps to

remove the grounds for cancelling the entry of the kind of device

from the Register under section 41GN, the Secretary may, by

written notice given to the person, extend the period specified in

the notice under subsection 41GA(1) by a further specified period

not exceeding 6 months.

(4) The Secretary must cause to be published in the Gazette, as soon as

practicable after the extension, a notice setting out particulars of

the extension.

41GD Revocation of suspension

(1) The Secretary must revoke the suspension if the Secretary is

satisfied that:

(a) the ground on which the kind of medical device concerned

was suspended from the Register no longer applies; and

(b) there are no other grounds for suspending the kind of device

from the Register.

(2) The Secretary’s power to revoke the suspension may be exercised:

(a) if the person in relation to whom the kind of medical device

concerned is included in the Register applies in writing to the

Secretary; or

(b) on the Secretary’s own initiative.

(3) After revoking the suspension, the Secretary must:

(a) within 20 working days after the revocation, give written

notice of the revocation to the person in relation to whom the

kind of medical device concerned is included in the Register;

and

(b) as soon as practicable after the revocation, cause to be

published in the Gazette a notice setting out particulars of the

revocation.

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Chapter 4 Medical devices

Part 4-6 Suspension and cancellation from the Register

Division 1 Suspension from the Register

Section 41GE

310 Therapeutic Goods Act 1989

(4) If the Secretary decides, after an application is made under

paragraph (2)(a), not to revoke the suspension, the Secretary must:

(a) notify the applicant in writing of his or her decision within 20

working days after the decision is made; and

(b) state in the notice the reasons for the decision.

41GE Treating applications for revocation as having been refused

(1) The applicant for the suspension to be revoked may give the

Secretary written notice that the applicant wishes to treat the

application as having been refused if:

(a) a period is prescribed under paragraph 63(2)(dd) for the

Secretary to make a decision on the application; and

(b) at the end of the period, the Secretary has not made a

decision.

(2) The notice may be given at any time before the Secretary makes a

decision on the application.

(3) If a notice has been given, this Act (except for subsection 60(5)) has

effect as if:

(a) the Secretary had decided not to revoke the suspension; and

(b) the Minister had made a decision under subsection 60(3)

confirming the decision of the Secretary; and

notice was given to the Secretary.

Subdivision B—Suspension as a result of suspension under

Part 4-4

41GF Suspension of kinds of medical devices from the Register

(1) The Secretary may, by written notice given to the person in relation

to whom a kind of medical device is included in the Register,

suspend the kind of device from the Register if the conformity

assessment certificate applying to that kind of device is suspended

under Division 3 of Part 4-4.

(2) If the suspension under Division 3 of Part 4-4 is limited to some

medical devices of that kind, the suspension under this section is

taken to be limited to the same extent.

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Medical devices Chapter 4

Suspension and cancellation from the Register Part 4-6

Suspension from the Register Division 1

Section 41GG

Therapeutic Goods Act 1989 311

(3) The Secretary must cause to be published in the Gazette, as soon as

practicable after the suspension, a notice setting out particulars of

the suspension.

41GG Duration of suspension

(1) The suspension takes effect on the day on which the notice is given

to the person.

(2) The suspension has effect until the Secretary revokes it under

section 41GH.

41GH Revocation of suspension

(1) The Secretary must revoke the suspension if:

(a) the suspension under Division 3 of Part 4-4 ceases to have

effect; and

(b) the Secretary is satisfied that there are no other grounds for

suspending the kind of device from the Register.

. (2) After revoking the suspension, the Secretary must:

(a) within 20 working days after the revocation, give written

notice of the revocation to the person in relation to whom the

kind of medical device concerned is included in the Register;

and

(b) as soon as practicable after the revocation, cause to be

published in the Gazette a notice setting out particulars of the

revocation.

Subdivision C—Effect of suspension

41GI Effect of suspension

If all or some medical devices of a particular kind are suspended,

they are taken, for the purposes of this Act (other than Division 2

of Part 4-5, this Division and Part 4-8), not to be included in the

Note: Dealing in medical devices that are not included in the Register may be an offence or may contravene a civil penalty provision: see Division 3 of Part 4-11.

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Chapter 4 Medical devices

Part 4-6 Suspension and cancellation from the Register

Division 1 Suspension from the Register

Section 41GJ

312 Therapeutic Goods Act 1989

41GJ Powers of cancellation from Register unaffected

(1) This Subdivision does not affect the Secretary’s powers to cancel

the entry of kinds of medical devices from the Register under

Division 2.

(2) To the extent that a suspension under this Division relates to

medical devices to which such a cancellation relates, the

suspension ceases to have effect.

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Medical devices Chapter 4

Suspension and cancellation from the Register Part 4-6

Cancellation of entries from the Register Division 2

Section 41GK

Therapeutic Goods Act 1989 313

Division 2—Cancellation of entries from the Register

41GK Automatic cancellation of entries of kinds of medical devices

from the Register

The Secretary must, by written notice given to the person in

relation to whom a kind of medical device is included in the

if:

(a) the kind of device has been suspended from the Register

under section 41GA, and the period applying to the

suspension under subsection 41GA(3) or 41GC(3) (as the

case requires) expires before the suspension is revoked under

section 41GD; or

(b) a conformity assessment certificate applying to that kind of

device is revoked under Division 4 of Part 4-4.

41GL Immediate cancellation of entries of kinds of medical devices

from the Register

The Secretary may, by written notice given to the person in relation

to whom a kind of medical device is included in the Register,

cancel the entry of the kind of device from the Register if:

(a) the Secretary is satisfied that there would be an imminent risk

of death, serious illness or serious injury if the kind of device

continues to be included in the Register; or

(b) devices of that kind are no longer therapeutic goods; or

(d) the person requests in writing the cancellation of the entry of

the kind of device from the Register; or

(e) the Secretary is satisfied that a statement made in or in

connection with:

(i) the application for including the kind of device in the

(ii) the certification or purported certification under

section 41FD relating to the application;

was false or misleading in a material particular; or

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Chapter 4 Medical devices

Part 4-6 Suspension and cancellation from the Register

Division 2 Cancellation of entries from the Register

Section 41GM

314 Therapeutic Goods Act 1989

(f) the annual charge payable under subsection 4(1B) of the

Therapeutic Goods (Charges) Act 1989 in respect of the

inclusion of the kind of device in the Register is not paid

within 20 working days after it becomes payable; or

(g) both of the following apply:

(i) under the regulations, an authority constituted by or

under the regulations gives a direction to, or makes a

requirement of, the person in relation to an

advertisement of the kind of device to ensure that

advertising complies with the Therapeutic Goods

Advertising Code;

(ii) the person does not comply with the direction or

requirement; or

(h) there is a serious breach, involving the kind of device, of the

requirements relating to advertising applicable under Part 5-1

or under the regulations, and the Secretary is satisfied that:

(i) the breach is significant; and

(ii) as a result of the breach, the presentation of devices of

that kind is misleading to a significant extent.

41GM Cancellation of entries of kinds of medical devices from the

Register after section 41JA notice

(1) The Secretary may, by written notice given to the person in relation

to whom a kind of medical device is included in the Register,

cancel the entry of the kind of device from the Register if:

(a) the Secretary gives to the person a notice under section 41JA

requiring the person to give to the Secretary information or

documents relating to the kind of device; and

(b) the notice under section 41JA is given for the purposes of

ascertaining whether the kind of device should have been

included in the Register; and

within a further 10 working days from the day specified in

that notice.

(2) The Secretary may, by written notice given to the person in relation

to whom a kind of medical device is included in the Register,

cancel the entry of the kind of device from the Register if:

(a) the Secretary gives to the person a notice under section 41JA

requiring the person to give to the Secretary information or

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Medical devices Chapter 4

Suspension and cancellation from the Register Part 4-6

Cancellation of entries from the Register Division 2

Section 41GN

Therapeutic Goods Act 1989 315

documents relating to whether medical devices of that kind

are being:

(i) supplied in Australia; or

(ii) imported into Australia; or

(iii) exported from Australia; and

(b) either:

(i) the information or documents given are to the effect that

medical devices of that kind are not being supplied in

Australia, imported into Australia or exported from

Australia; or

(ii) the person fails to comply with the notice under

section 41JA within a further 10 working days from the

day specified in that notice.

41GN Cancellation of entries of kinds of medical devices from the

Register after notice of proposed cancellation

(1) The Secretary may, by written notice given to the person in relation

to whom a kind of medical device is included in the Register,

cancel the entry of the kind of device from the Register if:

(a) medical devices that were devices of that kind when the kind

of device was included in the Register have changed so those

medical devices are no longer devices of that kind; or

(b) the person in relation to whom the kind of medical device is

included in the Register refuses or fails to comply with a

condition to which that inclusion is subject; or

(i) that requires the person to give to the Secretary

information or documents relating to the kind of device;

and

(ii) in respect of which section 41GM does not apply;

and the person fails to comply with that notice within a

further 10 working days from the day specified in that notice;

(d) the person contravenes subsection 41MP(1) or 41MPA(1) in

relation to the kind of device; or

(e) the Secretary is satisfied that the safety or performance of the

kind of device is unacceptable; or

(f) the Secretary is satisfied that any certification, or part of a

certification, under section 41FD in relation to the

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Chapter 4 Medical devices

Part 4-6 Suspension and cancellation from the Register

Division 2 Cancellation of entries from the Register

Section 41GO

316 Therapeutic Goods Act 1989

application for inclusion of the kind of device in the Register

is incorrect, or is no longer correct, in a material particular.

Note: The matters that must be certified under section 41FD include compliance with the essential principles and the application of conformity assessment procedures, being able to substantiate the compliance and application, and compliance with advertising requirements.

(2) However, before cancelling the entry of the kind of device from the

(a) inform the person in writing that the Secretary proposes the

cancellation and set out the reasons for it; and

(b) give the person a reasonable opportunity to make

submissions to the Secretary in relation to the proposed

cancellation.

(3) The Secretary is not to make a decision relating to the proposed

cancellation until the Secretary has had regard to any submissions

the person makes under paragraph (2)(b).

41GO Limiting cancellation of entries from Register to some

medical devices of a particular kind

(1) If the Secretary is satisfied that the ground for cancelling the entry

of a kind of medical device from the Register applies only to some

medical devices of that kind, the Secretary must limit the

cancellation to the medical devices to which that ground or any

other ground for cancellation applies.

(2) If the cancellation of the entry of a kind of medical device from the

Secretary:

(a) must vary the entry in the Register accordingly; and

(b) must not delete the entry from the Register because of the

cancellation.

41GP Publication of cancellation of entry from Register

The Secretary must cause to be published in the Gazette, as soon as

practicable after cancelling an entry from the Register of a kind of

medical device, or of some devices of a particular kind, a notice

setting out particulars of the cancellation.

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Medical devices Chapter 4

Suspension and cancellation from the Register Part 4-6

Cancellation of entries from the Register Division 2

Section 41GQ

Therapeutic Goods Act 1989 317

41GQ Date of effect of cancellation of entries from Register

If the Secretary cancels an entry of a kind of medical device, or

some devices of a particular kind, from the Register, the

cancellation has effect:

(a) if the cancellation is under section 41GK or 41GL—on the

day on which the notice of cancellation is given to the person

in relation to whom the kind of device was included in the

(b) in any other case—on such later day as is specified in the

notice, being a day not earlier than 20 working days after the

notice is given to the person.

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Chapter 4 Medical devices

Part 4-6A Exempting medical devices to deal with emergencies

Section 41GR

318 Therapeutic Goods Act 1989

Part 4-6A—Exempting medical devices to deal with

emergencies

41GR What this Part is about

The Minister may exempt certain medical devices from various

provisions of this Chapter so that the devices may be stockpiled to

deal with possible future emergencies or made available urgently

to deal with actual emergencies.

Note 1: There are offences and civil penalty provisions related to the making of exemptions under this Part: see Division 3A of Part 4-11.

Note 2: Some of the other provisions of this Act about medical devices exempt under this Part are:

(a) section 41JCA (providing information to the Secretary); and

(b) section 41KA (public notification and recovery of medical devices); and

41GS Minister may make exemptions

(1) The Minister may, by writing, exempt specified kinds of medical

devices from the operation of the following:

(a) Division 1 of Part 4-2 (essential principles);

(b) Division 1 of Part 4-3 (conformity assessment procedures);

(d) Part 4-5 (including medical devices in the Register).

(2) The Minister may make an exemption under subsection (1) only if

the Minister is satisfied that, in the national interest, the exemption

should be made so that:

(a) the devices may be stockpiled as quickly as possible in order

to create a preparedness to deal with a potential threat to

public health that may be caused by a possible future

emergency; or

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Medical devices Chapter 4

Exempting medical devices to deal with emergencies Part 4-6A

Section 41GT

Therapeutic Goods Act 1989 319

(b) the devices can be made available urgently in Australia in

order to deal with an actual threat to public health caused by

an emergency that has occurred.

Period of exemption

(3) An exemption under subsection (1) comes into force:

(a) on the day the exemption is made; or

(b) on a later day specified in the exemption.

(4) An exemption under subsection (1) remains in force for the period

specified in the exemption, unless revoked earlier.

Note: Section 41GU deals with variation and revocation of the exemption.

Effect of inclusion of kind of medical device in the Register

(5) An exemption under subsection (1) ceases to have effect in relation

to a particular kind of medical device when that kind of medical

device becomes included in the Register under Part 4-5.

Exemption not a legislative instrument

(6) An exemption under subsection (1) is not a legislative instrument.

Disregard section 41BE

(7) For the purposes of this Act, disregard section 41BE in working

out the kinds of medical devices covered by an exemption under

subsection (1) of this section.

41GT Conditions of exemptions

An exemption under section 41GS is subject to conditions

specified in the exemption about any of the following:

(a) the quantity of medical devices that are exempt;

(b) the source of those medical devices;

manufacture, supply or export those medical devices;

(d) the supply of those medical devices (including the persons or

class of persons to whom medical devices may be supplied

for use and the circumstances under which a stockpile of

medical devices may be supplied for use);

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Chapter 4 Medical devices

Part 4-6A Exempting medical devices to deal with emergencies

Section 41GU

320 Therapeutic Goods Act 1989

(e) the storage and security of those medical devices;

(f) the keeping and disclosure of, and access to, records about

those medical devices;

(g) the disposal of those medical devices;

(h) the manner in which any of those medical devices are to be

dealt with if a condition of the exemption is breached;

(i) any other matters that the Minister thinks appropriate.

Whether or not medical devices are exempt under section 41GS is

not affected by whether or not there is a breach of a condition

under this section in relation to those medical devices.

Note 1: There are offences and civil penalty provisions related to the breach of a condition of an exemption: see Division 3A of Part 4-11.

Note 2: Section 41GU deals with variation and revocation of the conditions.

41GU Variation or revocation of exemption

Variation of exemption

(1) The Minister may, by writing, vary an exemption made under

section 41GS by removing specified kinds of medical devices from

the exemption.

Revocation of exemption

(2) The Minister may, by writing, revoke an exemption made under

section 41GS.

Variation or revocation of conditions

(3) The Minister may, by writing:

(a) vary the conditions of an exemption made under

section 41GS (including by imposing new conditions); or

(b) revoke the conditions of an exemption made under

section 41GS.

When variation or revocation takes effect

(4) A variation or revocation under this section takes effect:

(a) if the Minister states in the variation or revocation that the

variation or revocation is necessary to prevent imminent risk

of death, serious illness or serious injury—on the day the

variation or revocation is made; or

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Medical devices Chapter 4

Exempting medical devices to deal with emergencies Part 4-6A

Section 41GV

Therapeutic Goods Act 1989 321

(b) in any other case—on a later day specified in the variation or

revocation (which must not be earlier than 28 days after the

day the variation or revocation is made).

41GV Informing persons of exemption etc.

If the Minister makes an exemption under section 41GS, the

Minister must take reasonable steps to give a copy of the following

to each person covered by paragraph 41GT(c):

(a) the exemption;

(b) any variation or revocation of the exemption under

section 41GU.

41GW Notification and tabling

Notification

(1) The Secretary must cause a notice setting out particulars of the

following:

(a) an exemption made under section 41GS because of

paragraph 41GS(2)(b);

(b) a variation or revocation under section 41GU, to the extent

that the variation or revocation relates to an exemption made

under section 41GS because of paragraph 41GS(2)(b);

to be published in the Gazette within 5 working days after the day

on which the exemption, variation or revocation is made. However,

the exemption, variation or revocation is not invalid merely

because of a failure to comply with this subsection.

Tabling

(2) The Minister must cause a document setting out particulars of the

following:

(a) an exemption made under section 41GS because of

paragraph 41GS(2)(b);

(b) a variation or revocation under section 41GU, to the extent

that the variation or revocation relates to an exemption made

under section 41GS because of paragraph 41GS(2)(b);

to be tabled in each House of the Parliament within 5 sitting days

of that House after the day on which the exemption, variation or

revocation is made. However, the exemption, variation or

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Chapter 4 Medical devices

Part 4-6A Exempting medical devices to deal with emergencies

Section 41GY

322 Therapeutic Goods Act 1989

revocation is not invalid merely because of a failure to comply

with this subsection.

41GY Disposal of unused medical devices

(1) This section applies to a medical device if:

(a) an exemption under section 41GS in relation to that kind of

medical device ceases to have effect otherwise than because

that kind of medical device becomes included in the Register

under Part 4-5; and

(b) the medical device has not been used before the exemption so

ceases to have effect.

(2) The Secretary may arrange for the disposal of the medical device

in accordance with the regulations.

(3) Regulations made for the purposes of subsection (2) may set out

the methods by which the medical device is to be stored, supplied,

destroyed, exported or otherwise disposed of.

(4) A method set out in the regulations under subsection (3) must not

enable or permit any benefit to be conferred on a person (including

the Commonwealth) other than the owner of the medical device.

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Medical devices Chapter 4

Other exemptions from including medical devices in the Register Part 4-7

Section 41H

Therapeutic Goods Act 1989 323

Part 4-7—Other exemptions from including

medical devices in the Register

41H What this Part is about

In addition to Part 4-6A, there are 4 other kinds of exemptions

from the prohibitions in Division 3 of Part 4-11 on dealing in

medical devices that are not included in the Register:

(a) medical devices exempted under the regulations;

(b) approval for medical devices to be used for special

treatment of individuals or for experimental

purposes;

supply specified medical devices;

(d) medical devices exempted if substitutes are

unavailable or in short supply.

41HA Devices exempted from inclusion in the Register

(1) The regulations may exempt from the operation of Division 3 of

Part 4-11:

(a) all medical devices, except those medical devices of the

kinds prescribed for the purposes of this paragraph; or

(b) specified kinds of medical devices.

Note: Division 3 of Part 4-11 contains offences and civil penalty provisions relating to dealing in medical devices that are not included in the Register.

(2) An exemption may be subject to conditions that are prescribed in

the regulations.

Note: Breach of the conditions may be an offence: see subsection 41MN(9).

(3) An exemption under paragraph (1)(a) has effect only for classes of

persons prescribed in the regulations for the purposes of this

subsection.

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Chapter 4 Medical devices

Part 4-7 Other exemptions from including medical devices in the Register

Section 41HB

324 Therapeutic Goods Act 1989

(4) If the regulations revoke an exemption, the revocation takes effect

on the day specified. The day must not be earlier than 20 working

days after the day on which the regulations are made.

41HB Exemptions for special and experimental uses

(1) The Secretary may grant a written approval to a person for:

(a) the importation into Australia; or

(b) the exportation from Australia; or

of a specified medical device or kind of medical device (other than

medical devices included in the Register or exempt devices):

(d) for use in the treatment of another person; or

(e) for use solely for experimental purposes in humans.

(2) The approval may be given subject to conditions specified in the

approval, including a condition relating to charging for medical

devices of the kinds in question.

Note: Breach of the conditions may be an offence: see subsection 41MN(9).

(3) In addition, the regulations may prescribe conditions that apply to a

person’s approval to use specified kinds of medical devices solely

for experimental purposes in humans. The conditions may relate to

one or more of the following:

(a) the preconditions on another person’s use of devices of those

kinds for those purposes;

(b) the principles to be followed in another person’s use of

devices of those kinds for those purposes;

use, of devices of those kinds for those purposes;

(d) the circumstances in which that other person must cease

using devices of those kinds for those purposes.

(4) An application to use specified medical devices in the treatment of

another person must be accompanied by any information about the

devices that is required by the Secretary.

(5) An application to use specified kinds of medical devices solely for

experimental purposes in humans must:

(a) be made in writing; and

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Medical devices Chapter 4

Other exemptions from including medical devices in the Register Part 4-7

Section 41HC

Therapeutic Goods Act 1989 325

(b) be accompanied by any information about the kinds of

devices that is required by the Secretary; and

(6) The Secretary must:

(a) consider any application under this section; and

(b) assess any information submitted with the application; and

decision:

(i) of the decision; and

(ii) in the case of a decision not to grant the approval—of

the reasons for the decision.

(7) The use by a person for experimental purposes in humans of

specified kinds of medical devices that are the subject of an

approval granted to someone else under paragraph (1)(e) is subject

to the conditions (if any) specified in the regulations relating to one

or more of the following:

(a) the preconditions on the use of devices of those kinds for

those purposes;

(b) the principles to be followed in the use of devices of those

kinds for those purposes;

devices of those kinds for those purposes;

(d) the circumstances in which the person must cease the use of

devices of those kinds for those purposes.

Note: Breach of the conditions may be an offence: see subsection 41MN(9).

41HC Exemptions for medical practitioners

(1) The Secretary may authorise, in writing, a specified medical

practitioner to supply specified kinds of medical devices for use in

the treatment of humans to a specified class of recipients.

(2) An authority may be given subject to conditions specified in the

authority.

(3) The Secretary may impose conditions (or further conditions) on a

person’s authority by giving the person written notice of the

conditions.

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Chapter 4 Medical devices

Part 4-7 Other exemptions from including medical devices in the Register

Section 41HD

326 Therapeutic Goods Act 1989

(4) An authority may only be given:

(a) to a medical practitioner included in a class of medical

practitioners prescribed by the regulations for the purposes of

this paragraph; and

(b) to a medical practitioner who has the approval of an ethics

committee to supply the specified kinds of medical devices

or the specified class of such devices; and

regulations for the purposes of this paragraph.

However, the regulations may prescribe exceptional circumstances

in which paragraph (b) does not apply.

(5) The regulations may prescribe circumstances in which medical

devices may be supplied under an authority.

(7) In this section:

medical practitioner means a person who is registered, in a State

or internal Territory, as a medical practitioner.

41HD Approvals if substitutes for medical devices are unavailable

or in short supply

(1) The Secretary may, by notice in writing, grant an approval to a

person for:

(a) the importation into Australia of a specified medical device;

(b) the importation into Australia of a specified medical device

and the supply in Australia of that device;

if the Secretary is satisfied that:

could act as a substitute for the medical device are

unavailable or are in short supply; and

(d) either:

(i) the medical device is registered or approved for general

marketing in at least one foreign country specified in a

determination under subsection (5); or

(ii) an application has been made in accordance with

section 41FC for inclusion in the Register of the kind of

medical device that includes the medical device; and

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Other exemptions from including medical devices in the Register Part 4-7

Section 41HD

Therapeutic Goods Act 1989 327

(e) the medical device is specified in a determination under

subsection (6); and

(f) the approval is necessary in the interests of public health.

Note: For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislative Instruments Act 2003.

(2) The Secretary may, by notice in writing, grant an approval to a

person for:

(a) the importation into Australia of a specified medical device;

(b) the importation into Australia of a specified medical device

and the supply in Australia of that device;

if the Secretary is satisfied that:

and

(d) an application has been made in accordance with

section 41FC for inclusion in the Register of the kind of

medical device that includes the medical device; and

(e) the medical device is specified in a determination under

subsection (6); and

(f) the approval is necessary in the interests of public health.

Note: For specification by class, see the Acts Interpretation Act 1901 and subsection 13(3) of the Legislative Instruments Act 2003.

Application for approval

(3) An application for an approval must:

(a) be made to the Secretary; and

(b) be accompanied by such information relating to the medical

device as is required by the Secretary.

Notification of Secretary’s decision

(4) If an application for an approval is made, the Secretary must, as

soon as practicable after deciding the application, notify the

applicant of:

(a) the decision; and

(b) if the decision is not to grant the approval—the reasons for

the decision.

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Chapter 4 Medical devices

Part 4-7 Other exemptions from including medical devices in the Register

Section 41HD

328 Therapeutic Goods Act 1989

Determinations

(5) The Secretary may, by legislative instrument, make a

determination specifying foreign countries for the purposes of

subparagraph (1)(d)(i).

(6) The Secretary may, by legislative instrument, make a

determination specifying medical devices that can be the subject of

an approval under this section.

Conditions

(7) The Secretary may grant an approval subject to any conditions that

are specified in the notice of approval.

Note: Breach of the conditions may be an offence: see subsection 41MN(9).

Period of approval

(8) The Secretary may grant an approval for such period as is specified

in the notice of approval.

When approval lapses

(9) The approval lapses if:

(a) the period specified in the notice of approval expires; or

(b) a decision has been made on an application that has been

made for inclusion in the Register of the kind of medical

device that includes the medical device.

(10) The approval lapses if:

(a) the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f),

or paragraph (2)(c), (d), (e) or (f), as the case requires, no

longer applies in relation to the medical device, or that a

condition of the approval has been contravened; and

(b) the Secretary has given to the person to whom the approval

was granted a notice stating that the Secretary is so satisfied.

(11) The lapsing of the approval on the expiry of the period specified in

the notice of approval does not prevent another approval being

granted under this section in relation to the medical device before

that lapsing. The other approval may be expressed to take effect on

the expiry of that period.

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Medical devices Chapter 4

Other exemptions from including medical devices in the Register Part 4-7

Section 41HD

Therapeutic Goods Act 1989 329

Approval not a legislative instrument

(12) An approval under subsection (1) or (2) is not a legislative

instrument.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-8 Obtaining information

Section 41J

330 Therapeutic Goods Act 1989

Part 4-8—Obtaining information

41J What this Part is about

The Secretary may seek information or documents relating to:

• the application of conformity assessment procedures;

• compliance with the essential principles;

• compliance with other requirements;

• distribution of, and other matters relating to, medical devices

covered by exemptions under Part 4-6A or Part 4-7.

Note: There are additional obligations relating to notifying defects in medical devices: see sections 41MP, 41MPA, 41MQ and 41MR.

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Medical devices Chapter 4

Obtaining information Part 4-8

Information relating to compliance with requirements and other matters Division 1

Section 41JA

Therapeutic Goods Act 1989 331

Division 1—Information relating to compliance with

requirements and other matters

41JA Secretary may require information

(1) The Secretary may, by written notice given to a person:

(a) who is an applicant for a conformity assessment certificate

that would relate to a kind of medical device; or

(b) who holds a conformity assessment certificate that relates to

a kind of medical device; or

(ba) who held, at any time during the notice period under

subsection (2), a conformity assessment certificate that

related to a kind of medical device; or

device in the Register; or

(d) in relation to whom a kind of medical device is included in

the Register; or

(da) in relation to whom a kind of medical device was, at any time

during the notice period under subsection (2), included in the

require the person to give to the Secretary information or

documents, relating to devices of that kind, that are relevant to one

or more of the following:

(e) whether the devices comply with the essential principles;

(f) whether the conformity assessment procedures have been

applied to the devices;

(g) whether the devices comply with conditions (if any) imposed

on a conformity assessment certificate issued in respect of

the device or the inclusion of the device in the Register;

(h) whether the devices comply with every requirement (if any)

relating to advertising applicable under Part 5-1 or under the

regulations;

(i) if the kind of medical device is included in the Register in

relation to the person—whether medical devices of that kind

are being:

(i) supplied in Australia; or

(ii) imported into Australia; or

(iii) exported from Australia;

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-8 Obtaining information

Division 1 Information relating to compliance with requirements and other matters

Section 41JA

332 Therapeutic Goods Act 1989

(ia) the safety and efficacy of the devices for the purposes for

which they are to be used;

(ib) the regulatory history of the devices in another country;

(j) any other matter prescribed by the regulations for the

purposes of this paragraph.

(1AA) If a notice is given under subsection (1) to a person covered by

paragraph (1)(ba), then paragraphs (1)(e) to (j) (to the extent to

which they are relevant) apply in relation to the period the person

held the certificate.

(1AB) If a notice is given under subsection (1) to a person covered by

paragraph (1)(da), then paragraphs (1)(e) to (j) (to the extent to

which they are relevant) apply in relation to the period the kind of

medical device was included in the Register.

(1A) The Secretary may, by written notice given to a person who is an

applicant for a conformity assessment certificate, require the

person to give to the Secretary such further information concerning

the application as is specified in the notice.

(1B) Requirements under subsections (1) and (1A) may be included in

the same notice.

(1C) The Secretary may, by written notice given to a person who holds a

conformity assessment certificate, require the person to give to the

Secretary specified information to be used by the Secretary in

deciding whether to suspend the certificate under section 41EM, or

to revoke the certificate under section 41ET, in relation to the

circumstances referred to in paragraph 41ET(1)(e).

(1D) Requirements under subsections (1) and (1C) may be included in

the same notice.

(2) For the purposes of paragraphs (1)(ba) and (da), the notice period

is the period:

(a) of the length specified in the regulations; and

(b) ending on the day before the Secretary gives the notice under

subsection (1).

(3) Nothing in this section affects the operation of Part VIIC of the

Crimes Act 1914 (which includes provisions that, in certain

circumstances, relieve persons from the requirement to disclose

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Medical devices Chapter 4

Obtaining information Part 4-8

Information relating to compliance with requirements and other matters Division 1

Section 41JB

Therapeutic Goods Act 1989 333

spent convictions and require persons aware of such convictions to

disregard them).

41JB Complying with the Secretary’s requirements

(1) The person must give the information or documents to the

Secretary:

(a) within such reasonable time, being not less than 10 working

days from the day on which the notice is given, as is

specified in the notice; and

(b) in such form as is specified in the notice.

(2) The form may require or permit information to be given in

accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

Offence for failing to comply with a notice

(3) A person commits an offence if:

(a) the person is given a notice under section 41JA; and

(b) the person fails to comply with the notice.

Penalty: 500 penalty units.

Note: Failure to comply with the notice might also lead to suspension or revocation of a conformity assessment certificate (see Divisions 3 and 4 of Part 4-4) or suspension or cancellation of the entry of a kind of medical device in the Register (see Part 4-6).

Offences for giving false or misleading information in purported

compliance with a notice

(4) A person commits an offence if:

(a) the person is given a notice under section 41JA in relation to

a kind of medical device; and

(b) the person gives information in purported compliance with

the notice; and

and

(d) either:

(i) the use of the kind of medical device has resulted in, or

will result in, harm or injury to any person; or

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-8 Obtaining information

Division 1 Information relating to compliance with requirements and other matters

Section 41JB

334 Therapeutic Goods Act 1989

(ii) the use of the kind of medical device, if the kind of

medical device were used, would result in harm or

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (7) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(5) A person commits an offence if:

(a) the person is given a notice under section 41JA in relation to

a kind of medical device; and

(b) the person gives information in purported compliance with

the notice; and

and

(d) the use of the kind of medical device, if the kind of medical

device were used, would be likely to result in harm or injury

to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(6) Subsection (5) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(7) A person commits an offence if:

(a) the person is given a notice under section 41JA; and

(b) the person gives information in purported compliance with

the notice; and

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

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Medical devices Chapter 4

Obtaining information Part 4-8

Information relating to compliance with requirements and other matters Division 1

Section 41JBA

Therapeutic Goods Act 1989 335

41JBA Civil penalty for giving false or misleading information in

purported compliance with a notice

A person contravenes this section if:

(a) the person is given a notice under section 41JA; and

(b) the person gives information in purported compliance with

the notice; and

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

41JC Self-incrimination

(1) A person is not excused from giving information or a document

under section 41JB on the ground that to do so would tend to

incriminate the person or expose the person to a penalty.

(2) However, in the case of an individual:

(a) the information given; or

(b) the giving of the document; or

indirect consequence of giving the information or document;

is not admissible in evidence in:

(d) criminal proceedings against the individual, except

proceedings under, or arising out of, subsection 41JB(4), (5)

or (7); or

(e) proceedings for a pecuniary penalty order against the

individual for a contravention of a civil penalty provision,

except civil proceedings under, or arising out of,

section 41JBA.

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Chapter 4 Medical devices

Part 4-8 Obtaining information

Division 2 Information relating to medical devices covered by exemptions

Section 41JCA

336 Therapeutic Goods Act 1989

Division 2—Information relating to medical devices

covered by exemptions

41JCA Secretary may require information etc. about medical

devices exempt under Part 4-6A

(1) This section applies to a person who is required to comply with a

condition of an exemption of a kind of medical device under

section 41GS.

(2) The Secretary may, by written notice given to the person, require

the person to give to the Secretary specified information or

documents relating to one or more of the following:

(a) the supply of devices of that kind;

(b) the handling of devices of that kind;

(d) the results of the supply of devices of that kind;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to devices of that kind.

(3) The notice must specify a reasonable period within which the

person to whom the notice is given must comply. The period must

be at least 10 working days starting on the day on which the notice

is given.

(4) The notice may require information to be given in accordance with

specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

41JD Secretary may require information etc. about devices

exempted under section 41HA from inclusion in the

Register

(1) The Secretary may give the sponsor of kinds of medical devices

exempted under subsection 41HA(1) from Division 3 of Part 4-11,

a written notice requiring the sponsor to give to the Secretary

specified information or documents relating to one or more of the

following:

(a) the supply of devices of those kinds;

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Medical devices Chapter 4

Obtaining information Part 4-8

Information relating to medical devices covered by exemptions Division 2

Section 41JE

Therapeutic Goods Act 1989 337

(b) the handling of devices of those kinds;

(d) the results of the supply of devices of those kinds;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to devices of those

kinds.

(2) If a medical device is exempt under subsection 41HA(1) because a

medical practitioner has signed a statement in accordance with

regulations made for the purposes of this section, the Secretary

may give the medical practitioner a written notice requiring the

medical practitioner to give to the Secretary specified information

or documents relating to one or more of the following:

(a) the condition of the person to whom the medical device is to

be given or is given;

(b) the supply of the device;

(d) the monitoring of the supply of the device;

(e) the results of the supply of the device;

(f) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to medical devices of

that kind.

(3) A notice under this section must specify a reasonable period within

which the person must comply. The period must be at least 10

working days starting on the day on which the notice is given.

(4) A notice under this section may require information to be given in

accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

41JE Secretary may require information relating to approvals

under section 41HB

Approval under subsection 41HB(1)

(1) The Secretary may give to a person granted an approval under

subsection 41HB(1) (special and experimental uses), in relation to

specified kinds of medical devices, a written notice requiring the

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-8 Obtaining information

Division 2 Information relating to medical devices covered by exemptions

Section 41JE

338 Therapeutic Goods Act 1989

person to give to the Secretary specified information or documents

relating to one or more of the following:

(a) the supply of devices of those kinds;

(b) the handling of devices of those kinds;

(d) the results of the supply of devices of those kinds;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to devices of those

kinds.

Approval under subsection 41HB(1)—use by another person

(2) The Secretary may give to a person using specified kinds of

medical devices, that are the subject of an approval granted to

someone else under paragraph 41HB(1)(e) (use solely for

experimental purposes in humans), a written notice requiring the

person to give to the Secretary specified information or documents

relating to either of both of the following:

(a) the use of devices of those kinds;

(b) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to devices of those

kinds.

Compliance period

(3) A notice under this section must specify a reasonable period within

which the person to whom the notice is given must comply. The

period must be at least 10 working days starting on the day on

which the notice is given.

Information may need to be given in accordance with specified

software requirements

(4) A notice under this section may require information to be given in

accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

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Medical devices Chapter 4

Obtaining information Part 4-8

Information relating to medical devices covered by exemptions Division 2

Section 41JF

Therapeutic Goods Act 1989 339

41JF Secretary may require information relating to authorities

under section 41HC

(1) The Secretary may give to a person who is granted an authority

under section 41HC (exemptions for medical practitioners), in

relation to specified kinds of medical devices, a written notice

requiring the person to give to the Secretary specified information

or documents relating to one or more of the following:

(a) the supply of devices of those kinds;

(b) the handling of devices of those kinds;

(d) the results of the supply of devices of those kinds;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to devices of those

kinds.

(2) The notice must specify a reasonable period within which the

person to whom the notice is given must comply. The period must

be at least 10 working days starting on the day on which the notice

is given.

(3) The notice may require information to be given in accordance with

specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

41JFA Secretary may require information relating to approvals

under section 41HD

(1) The Secretary may give to a person who is granted an approval

under subsection 41HD(1) or (2) in relation to a medical device a

written notice requiring the person to give to the Secretary

specified information or documents relating to one or more of the

following:

(a) the supply of the medical device;

(b) the handling of the medical device;

(d) the results of the supply of the medical device;

(e) any other matter prescribed by the regulations for the

purposes of this paragraph in relation to the kind of medical

device that includes the medical device.

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Chapter 4 Medical devices

Part 4-8 Obtaining information

Division 2 Information relating to medical devices covered by exemptions

Section 41JG

340 Therapeutic Goods Act 1989

(2) The notice must specify a reasonable period within which the

person must comply. The period must be at least 10 working days

starting on the day on which the notice is given.

(3) The notice may require information to be given in accordance with

specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

41JG Criminal offences for failing to give information or documents

sought under this Division

A person commits an offence if:

(a) the person is given a notice under section 41JCA, 41JD,

41JE, 41JF or 41JFA; and

(b) the person fails to comply with the notice.

Penalty: 400 penalty units.

Note: The privilege against self incrimination is not a reasonable excuse for the purposes of this section. However, section 41JJ limits the use in prosecutions of information etc. obtained under sections 41JCA, 41JD, 41JE, 41JF and 41JFA.

41JH False or misleading information

A person to whom a notice is given under section 41JCA, 41JD,

41JE, 41JF or 41JFA is guilty of an offence if:

(a) the person gives information to the Secretary; and

(b) the person knows that the information:

(i) is false or misleading; or

(ii) omits any matter or thing without which the information

is misleading; and

compliance with the notice.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

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Medical devices Chapter 4

Obtaining information Part 4-8

Information relating to medical devices covered by exemptions Division 2

Section 41JI

Therapeutic Goods Act 1989 341

41JI False or misleading documents

(1) A person is guilty of an offence if:

(a) the person produces a document to the Secretary; and

(b) the person knows that the document is false or misleading;

and

compliance with a notice given under section 41JCA, 41JD,

41JE, 41JF or 41JFA.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Subsection (1) does not apply to a person who produces a

document if the document is accompanied by a written statement

signed by the person or, in the case of a body corporate, by a

competent officer of the body corporate:

(a) stating that the document is, to the knowledge of the

first-mentioned person, false or misleading in a material

particular; and

(b) setting out, or referring to, the material particular in which

the document is, to the knowledge of the first-mentioned

person, false or misleading.

Note: A defendant bears an evidential burden in relation to the matter in subsection (2) (see subsection 13.3(3) of the Criminal Code).

41JJ Self-incrimination

(1) A person is not excused from giving information or a document

under a notice given under section 41JCA, 41JD, 41JE, 41JF or

41JFA on the ground that to do so would tend to incriminate the

person or expose the person to a penalty.

(2) However, in the case of an individual:

(a) the information given; or

(b) the giving of the document; or

indirect consequence of giving the information or document;

is not admissible in evidence in:

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Chapter 4 Medical devices

Part 4-8 Obtaining information

Division 2 Information relating to medical devices covered by exemptions

Section 41JJ

342 Therapeutic Goods Act 1989

(d) criminal proceedings against the individual, except

proceedings under, or arising out of, section 41JH or 41JI; or

(e) proceedings for a pecuniary penalty order against the

individual for a contravention of a civil penalty provision.

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Public notification and recovery of medical devices Part 4-9

Section 41K

Therapeutic Goods Act 1989 343

Part 4-9—Public notification and recovery of

medical devices

41K What this Part is about

The Secretary can require action to recover medical devices, or to

inform the public about medical devices, that do not comply with

requirements or cannot lawfully be supplied.

41KA Public notification and recovery of medical devices

(1) The Secretary may, in writing, impose requirements, relating to a

kind of medical device, on a person if:

(a) any of the circumstances referred to in the second column of

an item in the following table occur in relation to the kind of

device; and

(b) the person is referred to in the third column of that item of

the table.

Circumstances in which requirements may be imposed

Item Circumstance relating to a kind of medical

device

Person subject to

requirements

1. It is supplied while it is included in the

not comply with the essential principles

The person in relation to

whom it is included in the

2. It is supplied while it is included in the

procedures have not been applied to medical

devices of that kind

The person in relation to

whom it is included in the

3. It is supplied while:

(a) medical devices of that kind are exempt

devices; or

(b) there is an approval under section 41HB

relating to devices of that kind; or

(d) there is an approval under

The person supplying the

kind of medical device

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Chapter 4 Medical devices

Part 4-9 Public notification and recovery of medical devices

Section 41KA

344 Therapeutic Goods Act 1989

Circumstances in which requirements may be imposed

Item Circumstance relating to a kind of medical

device

Person subject to

requirements

subsection 41HD(1) or (2) relating to

devices of that kind;

but medical devices of that kind do not

comply with the essential principles

4. It is supplied while:

(a) medical devices of that kind are exempt

devices; or

(b) there is an approval under section 41HB

relating to devices of that kind; or

(d) there is an approval under

subsection 41HD(1) or (2) relating to

devices of that kind;

but the conformity assessment procedures

have not been applied to medical devices of

that kind

The person supplying the

kind of medical device

5. It is supplied while:

(a) it is not included in the Register; and

(aa) it is not covered by an exemption in force

under section 41GS; and

(b) it is not an exempt device; and

section 41HB relating to devices of that

kind; and

(d) there is not an authority under

section 41HC relating to devices of that

kind; and

(e) there is not an approval under

subsection 41HD(1) or (2) relating to

devices of that kind.

The person supplying the

kind of medical device

5A. It is supplied while it is covered by an

exemption in force under section 41GS, and

the Secretary is satisfied that it is not fit to be

used for its intended purpose

The person supplying the

kind of medical device

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Public notification and recovery of medical devices Part 4-9

Section 41KB

Therapeutic Goods Act 1989 345

Circumstances in which requirements may be imposed

Item Circumstance relating to a kind of medical

device

Person subject to

requirements

5B. It is supplied while it is included in the

the quality, safety or performance of medical

devices of that kind is unacceptable

The person in relation to

whom the kind of medical

device is included in the

6. It has been suspended from the Register The person in relation to

whom it was included in the

7. Its entry has been cancelled from the Register The person in relation to

whom it was included in the

(2) The requirements may be one or both of the following:

(a) to take specified steps, in the specified manner and within

such reasonable period as is specified, to recover medical

devices of that kind that have been distributed;

(b) to inform the public or a specified class of persons, in the

specified manner and within such reasonable period as is

specified, to the effect that the circumstances referred to in

paragraph (1)(a) have occurred in relation to medical devices

of that kind.

(3) If the circumstances referred to in paragraph (1)(a) apply only to

some medical devices of that kind, the Secretary may limit the

imposition of the requirements to the medical devices of that kind

to which those circumstances apply.

(4) A requirement to recover medical devices under this section does

not apply to a medical device that cannot be recovered because it

has been administered to, or applied in the treatment of, a person.

41KB Publication of requirements

The Secretary must cause to be published in the Gazette, as soon as

practicable after imposing a requirement under section 41KA, a

notice setting out particulars of the requirement.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-9 Public notification and recovery of medical devices

Section 41KC

346 Therapeutic Goods Act 1989

41KC Criminal offences for failing to comply with requirements

relating to a kind of medical device

(1) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 41KA; and

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 41KA; and

person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a requirement imposed on the

person under section 41KA.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Public notification and recovery of medical devices Part 4-9

Section 41KCA

Therapeutic Goods Act 1989 347

41KCA Civil penalty for failing to comply with requirements

relating to a kind of medical device

A person contravenes this section if:

(a) the person does an act or omits to do an act; and

(b) the act or omission contravenes a requirement imposed on

the person under section 41KA.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

41KD Powers of suspension and cancellation unaffected

Imposition of a requirement under section 41KA does not affect

the Secretary’s powers to:

(a) suspend the entry of a kind of medical device, or some

medical devices of a particular kind, from the Register under

Part 4-6; or

(b) cancel the entry of a kind of medical device, or some medical

devices of a particular kind, in the Register under Part 4-6.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-10 Assessment fees

Section 41L

348 Therapeutic Goods Act 1989

Part 4-10—Assessment fees

41L What this Part is about

Conformity assessment fees must be paid for consideration of

applications for conformity assessment certificates. Application

audit assessment fees must be paid for auditing applications that

are required to be selected for auditing under

paragraph 41FH(1)(a).

41LA Assessment fees

(1) A conformity assessment fee specified in or determined in

accordance with the regulations is payable by a person in respect of

consideration of an application for a conformity assessment

certificate under Part 4-4.

(2) The regulations may prescribe different levels of conformity

assessment fees in relation to any one or more of the following:

(a) different kinds of manufacturers;

(b) different kinds of medical devices;

are considered in relation to an application for a conformity

assessment certificate under Part 4-4.

(3) An application audit assessment fee specified in or determined in

accordance with the regulations is payable by a person in respect of

the auditing of an application for inclusion of a kind of medical

device in the Register under Part 4-5, if paragraph 41FH(1)(a)

required the Secretary to select the application for audit.

(4) The regulations may prescribe different levels of application audit

assessment fees in relation to any one or more of the following:

(a) different kinds of manufacturers;

(b) different kinds of medical devices;

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Assessment fees Part 4-10

Section 41LB

Therapeutic Goods Act 1989 349

(5) The application audit assessment fee payable because of

subsection (3) is payable only in respect of considering the matters

set out in subsection 41FI(1).

41LB When assessment fee due for payment

Subject to sections 41LC and 41LE, an assessment fee payable by

an applicant is due and payable on the day, and in the manner,

specified in the regulations.

41LC Payment of assessment fee by instalments

(1) The regulations may provide for the payment of an assessment fee

to be made by such instalments and at such times as are ascertained

in accordance with the regulations, and the assessment fee is due

and payable accordingly.

(2) Regulations made for the purposes of subsection (1) may provide

that a person is not allowed to pay an assessment fee by instalments

if any part of an instalment of:

(a) that or any other assessment fee payable by the person; or

(b) any evaluation fee under section 24 payable by the person;

was unpaid immediately after the time when it became due for

payment.

(3) Subsection (2) does not limit the generality of subsection (1).

41LD Recovery of assessment fee

An assessment fee may be recovered by the Commonwealth as a

debt due to the Commonwealth.

41LE Reduction of conformity assessment fee where decision not

made within prescribed period

(1) Nothing in section 41LA, 41LB or 41LC requires the applicant to

pay more than 3/4 of the conformity assessment fee before the

making of the decision if:

(a) the application is for the issuing of a conformity assessment

certificate under Part 4-4; and

(b) consideration of the application will involve an examination

of the design of medical devices; and

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-10 Assessment fees

Section 41LE

350 Therapeutic Goods Act 1989

a decision on the application.

(2) If the decision is not made within that period, the conformity

assessment fee is 3/4 of the fee that, apart from this subsection,

would have been the conformity assessment fee.

(3) If:

(a) the decision is made within that period; and

(b) part of the conformity assessment fee under section 41LA is,

because of subsection (1) of this section, unpaid when the

decision is made;

that part becomes due and payable on the making of the decision.

(4) For the purposes of this section, a decision is taken to be made on

the application when the applicant is notified under

subsection 41EE(1) of the Secretary’s decision on the application.

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Section 41M

Therapeutic Goods Act 1989 351

Part 4-11—Offences and civil penalty provisions

relating to medical devices

41M What this Part is about

This Part contains offences and civil penalty provisions that are

aimed at ensuring that:

• the essential principles are complied with (see Division 1);

• the conformity assessment procedures have been applied to

kinds of medical devices (see Division 2);

• administrative processes put in place by Parts 4-4 to 4-9 are

followed (see Divisions 3, 3A and 4).

Note: There are also some offences and civil penalty provisions in the earlier Parts of this Chapter. They generally relate to matters ancillary to administrative processes in those Parts (e.g. false or misleading statements in applications).

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 1 Non-compliance with essential principles

Section 41MA

352 Therapeutic Goods Act 1989

Division 1—Non-compliance with essential principles

41MA Criminal offences for importing, supplying or exporting a

medical device that does not comply with essential

principles

Offences relating to importing a medical device

(1) A person commits an offence if:

(a) the person imports a medical device into Australia; and

(b) the medical device does not comply with the essential

principles relating to matters other than the labelling of the

device; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

(d) either:

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the device, if the device were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the device does not comply with the essential

principles.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person imports a medical device into Australia; and

(b) the medical device does not comply with the essential

principles relating to matters other than the labelling of the

device; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Non-compliance with essential principles Division 1

Section 41MA

Therapeutic Goods Act 1989 353

(d) the use of the device, if the device were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

device does not comply with the essential principles.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person imports a medical device into Australia; and

(b) the medical device does not comply with the essential

principles relating to matters other than the labelling of the

device; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Offences relating to supplying a medical device

(5) A person commits an offence if:

(a) the person supplies a medical device for use in Australia; and

(b) the medical device does not comply with the essential

principles; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

(d) either:

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the device, if device were used, would result

in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the device does not comply with the essential

principles.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 1 Non-compliance with essential principles

Section 41MA

354 Therapeutic Goods Act 1989

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(6) A person commits an offence if:

(a) the person supplies a medical device for use in Australia; and

(b) the medical device does not comply with the essential

principles; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

(d) the use of the device, if the device were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

device does not comply with the essential principles.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(7) Subsection (6) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(8) A person commits an offence if:

(a) the person supplies a medical device for use in Australia; and

(b) the medical device does not comply with the essential

principles; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Offences relating to exporting a medical device

(9) A person commits an offence if:

(a) the person exports a medical device from Australia; and

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Non-compliance with essential principles Division 1

Section 41MA

Therapeutic Goods Act 1989 355

(b) the medical device does not comply with the essential

principles; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

(d) either:

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the device, if the device were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the device does not comply with the essential

principles.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (12) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(10) A person commits an offence if:

(a) the person exports a medical device from Australia; and

(b) the medical device does not comply with the essential

principles; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

(d) the use of the device, if the device were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

device does not comply with the essential principles.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(11) Subsection (10) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(12) A person commits an offence if:

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 1 Non-compliance with essential principles

Section 41MAA

356 Therapeutic Goods Act 1989

(a) the person exports a medical device from Australia; and

(b) the medical device does not comply with the essential

principles; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Exception

(13) Paragraphs (9)(b), (10)(b) and (12)(b) do not apply to the extent

that the essential principles in question relate to labelling medical

devices for supply in Australia.

Note: A defendant bears an evidential burden in relation to the matters in this subsection: see subsection 13.3(3) of the Criminal Code.

41MAA Civil penalties for importing, supplying or exporting a

medical device that does not comply with essential

principles

Civil penalty relating to importing a medical device

(1) A person contravenes this subsection if:

(a) the person imports a medical device into Australia; and

(b) the medical device does not comply with the essential

principles relating to matters other than the labelling of the

device; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Civil penalty relating to supplying a medical device

(2) A person contravenes this subsection if:

(a) the person supplies a medical device for use in Australia; and

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Non-compliance with essential principles Division 1

Section 41MB

Therapeutic Goods Act 1989 357

(b) the medical device does not comply with the essential

principles; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Civil penalty relating to exporting a medical device

(3) A person contravenes this subsection if:

(a) the person exports a medical device from Australia; and

(b) the medical device does not comply with the essential

principles; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

41MB Exceptions

(1) Sections 41MA and 41MAA do not apply if:

(a) the medical device complies with one or more medical

device standards that apply to it; and

(b) the medical device fails to comply with the essential

principles only in respect of a part or parts of the essential

principles to which that medical device standard, or one or

more of those medical device standards, relate.

Note: Medical device standards are determined under Division 2 of Part 4-2.

(2) For the purposes of this section, a medical device standard relates

to a part or parts of the essential principles only if the standard

specifies that part or parts.

Note 1: In the prosecution for an offence, the defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 1 Non-compliance with essential principles

Section 41MC

358 Therapeutic Goods Act 1989

Note 2: In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.

41MC Criminal offences relating to breaching a condition of a

consent

(1) The consent of the Secretary under section 41MA or 41MAA may

be given:

(a) unconditionally or subject to conditions; or

(b) in respect of particular medical devices or kinds of medical

devices.

(2) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent; and

injury to any person.

Penalty: 2,000 penalty units.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (5) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent; and

person.

Penalty: 1,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4) Subsection (3) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(5) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent.

Penalty: 500 penalty units.

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Non-compliance with essential principles Division 1

Section 41MCA

Therapeutic Goods Act 1989 359

41MCA Civil penalty relating to breaching a condition of a consent

A person contravenes this section if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches a condition of a consent

imposed under section 41MC.

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

41MD Treating medical devices as prohibited imports or exports

If:

(a) the importation or exportation of a medical device is an

offence under subsection 41MA(1), (2), (4), (9), (10) or (12)

or a contravention of subsection 41MAA(1) or (3); and

(b) the Secretary notifies the Chief Executive Officer of Customs

in writing that the Secretary wishes the Customs Act 1901 to

apply to that importation or exportation;

the Customs Act 1901 has effect as if the device included in that

importation or exportation were goods described as forfeited to the

Crown under section 229 of that Act because they were:

(d) prohibited exports within the meaning of that Act;

as the case requires.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 2 Failure to apply conformity assessment procedures

Section 41ME

360 Therapeutic Goods Act 1989

Division 2—Failure to apply conformity assessment

procedures

41ME Criminal offences for failing to apply conformity assessment

procedures—manufacturers

Offences relating to supplying a medical device

(1) A person commits an offence if:

(a) the person manufactures a medical device; and

(b) the person supplies the device in Australia; and

to the device; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

(d) either:

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the device, if the device were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the conformity assessment procedures have not been

applied to the device.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person manufactures a medical device; and

(b) the person supplies the device in Australia; and

to the device; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Failure to apply conformity assessment procedures Division 2

Section 41ME

Therapeutic Goods Act 1989 361

(d) the use of the device, if the device were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

conformity assessment procedures have not been applied to

the device.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person manufactures a medical device; and

(b) the person supplies the device in Australia; and

to the device; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Offences relating to exporting a medical device

(5) A person commits an offence if:

(a) the person manufactures a medical device; and

(b) the person exports the device from Australia; and

to the device; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

(d) either:

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the device, if the device were used, would

result in harm or injury to any person; and

(e) the harm or injury has resulted, will result, or would result,

because the conformity assessment procedures have not been

applied to the device.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 2 Failure to apply conformity assessment procedures

Section 41ME

362 Therapeutic Goods Act 1989

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(6) A person commits an offence if:

(a) the person manufactures a medical device; and

(b) the person exports the device from Australia; and

to the device; and

(ca) the device is not of a kind covered by an exemption in force

under section 41GS; and

(d) the use of the device, if the device were used, would be likely

to result in harm or injury to any person; and

(e) the harm or injury would be likely to result because the

conformity assessment procedures have not been applied to

the device.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(7) Subsection (6) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(8) A person commits an offence if:

(a) the person manufactures a medical device; and

(b) the person exports the device from Australia; and

to the device; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Failure to apply conformity assessment procedures Division 2

Section 41MEA

Therapeutic Goods Act 1989 363

41MEA Civil penalties for failing to apply conformity assessment

procedures—manufacturers

Civil penalty relating to supplying a medical device

(1) A person contravenes this subsection if:

(a) the person supplies a medical device in Australia; and

(b) the person has manufactured the device; and

to the device; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Civil penalty relating to exporting a medical device

(2) A person contravenes this subsection if:

(a) the person exports a medical device from Australia; and

(b) the person has manufactured the device; and

to the device; and

(d) the device is not of a kind covered by an exemption in force

under section 41GS.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

41MF Criminal offences for failing to apply conformity assessment

procedures—sponsors

Offences relating to supplying a medical device

(1) A person commits an offence if:

(a) the person supplies a medical device in Australia; and

(b) the conformity assessment procedures have not been applied

to the device; and

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 2 Failure to apply conformity assessment procedures

Section 41MF

364 Therapeutic Goods Act 1989

(ba) the device is not of a kind covered by an exemption in force

under section 41GS; and

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the device, if the device were used, would

result in harm or injury to any person; and

(d) the harm or injury has resulted, will result, or would result,

because the conformity assessment procedures have not been

applied to the device.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (2) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) the person supplies a medical device in Australia; and

(b) the conformity assessment procedures have not been applied

to the device; and

under section 41GS.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Offences relating to exporting a medical device

(3) A person commits an offence if:

(a) the person exports a medical device from Australia; and

(b) the conformity assessment procedures have not been applied

to the device; and

(ba) the device is not of a kind covered by an exemption in force

under section 41GS; and

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the device, if the device were used, would

result in harm or injury to any person; and

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Failure to apply conformity assessment procedures Division 2

Section 41MG

Therapeutic Goods Act 1989 365

(d) the harm or injury has resulted, will result, or would result,

because the conformity assessment procedures have not been

applied to the device.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4) A person commits an offence if:

(a) the person exports a medical device from Australia; and

(b) the conformity assessment procedures have not been applied

to the device; and

under section 41GS.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Exception

(5) This section does not apply if the defendant was not the sponsor of

the device at the time of the supply or exportation, as the case may

be.

Note: A defendant bears an evidential burden in relation to the matters in subsection (5): see subsection 13.3(3) of the Criminal Code.

41MG Exceptions

(1) Sections 41ME, 41MEA and 41MF do not apply to the extent that:

(a) the quality management systems applied to the medical

device comply with one or more conformity assessment

standards that apply to them; and

(b) the conformity assessment procedures have not been applied

to the device only in respect of a part or parts of the

conformity assessment procedures to which one or more of

those conformity assessment standards relate.

Note: Conformity assessment standards are determined under Division 2 of Part 4-3.

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Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 2 Failure to apply conformity assessment procedures

Section 41MH

366 Therapeutic Goods Act 1989

(2) For the purposes of this section, a conformity assessment standard

relates to a part or parts of the conformity assessment procedures

only if the standard specifies that part or parts.

Note 1: In the prosecution for an offence, the defendant bears an evidential burden in relation to the matters in this section (see subsection 13.3(3) of the Criminal Code).

Note 2: In proceedings for the contravention of a civil penalty provision, the defendant must prove the matters in this section.

41MH Criminal offence for making false statements in declarations

A person is guilty of an offence if:

(a) the person makes a statement in or in connection with a

declaration, relating to the application of conformity

assessment procedures to a medical device that the person

has manufactured; and

(b) the statement is false or misleading in a material particular.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

41MHA Civil penalty for making false statements in declarations

A person contravenes this section if:

(a) the person manufactures a medical device; and

(b) the person makes a statement in or in connection with a

declaration relating to the application of conformity

assessment procedures to the device; and

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

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Medical devices not included in the Register and related matters Division 3

Section 41MI

Therapeutic Goods Act 1989 367

Division 3—Medical devices not included in the Register

and related matters

41MI Criminal offences for importing, exporting, supplying or

manufacturing a medical device not included in the

Register

(1) A person commits an offence if:

(a) the person:

(i) imports a medical device into Australia; or

(ii) exports a medical device from Australia; or

(iii) supplies a medical device in Australia; or

(iv) manufactures a medical device in Australia; and

(b) none of the following subparagraphs applies in relation to the

device:

(i) the device is of a kind included in the Register in

relation to the person;

(ia) the device is of a kind covered by an exemption in force

under section 41GS;

(ii) the device is an exempt device;

(iii) the device is the subject of an approval under

section 41HB or an authority under section 41HC;

(iv) the device is the subject of an approval under

subsection 41HD(1) or (2) that is held by the person;

and

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the device, if the device were used, would

result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

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Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 3 Medical devices not included in the Register and related matters

Section 41MI

368 Therapeutic Goods Act 1989

(a) the person:

(i) imports a medical device into Australia; or

(ii) exports a medical device from Australia; or

(iii) supplies a medical device in Australia; or

(iv) manufactures a medical device in Australia; and

(b) none of the following subparagraphs applies in relation to the

device:

(i) the device is of a kind included in the Register in

relation to the person;

(ia) the device is of a kind covered by an exemption in force

under section 41GS;

(ii) the device is an exempt device;

(iii) the device is the subject of an approval under

section 41HB or an authority under section 41HC;

(iv) the device is the subject of an approval under

subsection 41HD(1) or (2) that is held by the person;

and

to result in harm or injury to any person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person:

(i) imports a medical device into Australia; or

(ii) exports a medical device from Australia; or

(iii) supplies a medical device in Australia; or

(iv) manufactures a medical device in Australia; and

(b) none of the following subparagraphs applies in relation to the

device:

(i) the device is of a kind included in the Register in

relation to the person;

(ia) the device is of a kind covered by an exemption in force

under section 41GS;

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Medical devices not included in the Register and related matters Division 3

Section 41MI

Therapeutic Goods Act 1989 369

(ii) the device is an exempt device;

(iii) the device is the subject of an approval under

section 41HB or an authority under section 41HC;

(iv) the device is the subject of an approval under

subsection 41HD(1) or (2) that is held by the person.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

(5) Strict liability applies to paragraph (4)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

Defence if person was not the sponsor of the goods

(6) It is a defence to a prosecution under subsection (1), (2) or (4) if

the defendant proves that the defendant was not the sponsor of the

device at the time of the importation, exportation, supply, or

manufacture, as the case may be.

Note: A defendant bears a legal burden in relation to the matters in subsection (6): see section 13.4 of the Criminal Code.

Exception

(7) Subsection (1) does not apply if:

(a) harm or injury did not, or will not, directly result from:

(i) the quality, safety or performance of the medical device;

(ii) a matter relating to the labelling or packaging of the

medical device; or

(iii) the improper use of the medical device; or

(b) harm or injury would not directly result from:

(i) the quality, safety or performance of the medical device;

(ii) a matter relating to the labelling or packaging of the

medical device; or

(iii) the improper use of the medical device.

Note: A defendant bears an evidential burden in relation to the matters in subsection (7): see subsection 13.3(3) of the Criminal Code.

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Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 3 Medical devices not included in the Register and related matters

Section 41MIA

370 Therapeutic Goods Act 1989

41MIA Notice required to adduce evidence in support of exception

under subsection 41MI(7)

(1) If:

(a) a defendant is committed for trial for an offence against

subsection 41MI(1); or

(b) an offence against subsection 41MI(1) is to be heard and

determined by a court of summary jurisdiction;

the committing magistrate or the court must:

(d) cause a copy of this section to be given to the defendant.

(2) A defendant must not, without leave of the court, adduce evidence

in support of the exception under subsection 41MI(7) unless:

(a) if paragraph (1)(a) applies—more than 21 days before the

trial begins; or

(b) if paragraph (1)(b) applies—more than 21 days before the

hearing of the offence begins;

he or she gives notice of particulars of the exception.

(3) A defendant must not, without leave of the court, call any other

person to give evidence in support of the exception unless:

(a) the notice under subsection (2) includes the name and

address of the person or, if the name and address is not

known to the defendant at the time he or she gives the notice,

any information in his or her possession that might be of

material assistance in finding the person; and

(b) if the name or the address is not included in the notice—the

court is satisfied that the defendant before giving the notice

took, and after giving the notice continued to take, all

reasonable steps to ascertain the name or address; and

defendant subsequently ascertains the name or address or

receives information that might be of material assistance in

finding the person—the defendant immediately gives notice

of the name, address or other information, as the case may

be; and

(d) if the defendant is told by or on behalf of the prosecutor that

the person has not been found by the name, or at the address,

given by the defendant:

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Section 41MIB

Therapeutic Goods Act 1989 371

(i) the defendant immediately gives notice of any

information in the defendant’s possession that might be

of material assistance in finding the person; or

(ii) if the defendant later receives any such information—

the defendant immediately gives notice of the

information.

(4) A notice purporting to be given under this section on behalf of the

defendant by his or her legal practitioner is, unless the contrary is

proved, taken as having been given with the authority of the

defendant.

(5) Any evidence tendered to disprove that the exception applies may,

subject to direction by the court, be given before or after evidence

is given in support of the exception.

(6) A notice of particulars of the exception must be given, in writing,

to the Director of Public Prosecutions. A notice is taken as having

been given if it is:

(a) delivered to or left at the Office of the Director of Public

Prosecutions; or

(b) sent by certified mail addressed to the Director of Public

Prosecutions at the Office of the Director of Public

Prosecutions.

(7) In this section:

Director of Public Prosecutions means a person holding office as,

or acting as, the Director of Public Prosecutions under the Director

of Public Prosecutions Act 1983.

41MIB Civil penalty for importing, exporting, supplying or

manufacturing a medical device not included in the

Register

(1) A person contravenes this section if:

(a) the person does any of the following:

(i) imports a medical device into Australia;

(ii) exports a medical device from Australia;

(iii) supplies a medical device in Australia;

(iv) manufactures a medical device in Australia; and

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Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 3 Medical devices not included in the Register and related matters

Section 41MJ

372 Therapeutic Goods Act 1989

(b) none of the following subparagraphs apply in relation to the

device:

(i) the device is of a kind included in the Register in

relation to the person;

(ia) the device is of a kind covered by an exemption in force

under section 41GS;

(ii) the device is an exempt device;

(iii) the device is the subject of an approval under

section 41HB or an authority under section 41HC;

(iv) the device is the subject of an approval under

subsection 41HD(1) or (2) that is held by the person.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

Exception

(2) Subsection (1) does not apply if the defendant proves that the

defendant was not the sponsor of the device at the time of the

importation, exportation, supply, or manufacture, as the case may

be.

41MJ Treating medical devices as prohibited imports or exports

If:

(a) the importation or exportation of a medical device is an

offence under subsection 41MI(1), (2) or (4) or a

contravention of section 41MIB; and

(b) the Secretary notifies the Chief Executive Officer of Customs

in writing that the Secretary wishes the Customs Act 1901 to

apply to that importation or exportation;

the Customs Act 1901 has effect as if the device included in that

importation or exportation were goods described as forfeited to the

Crown under section 229 of that Act because they were:

(d) prohibited exports within the meaning of that Act;

as the case requires.

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Medical devices not included in the Register and related matters Division 3

Section 41MK

Therapeutic Goods Act 1989 373

41MK Wholesale supply of medical devices not included in the

Register

A person is guilty of an offence if:

(a) the person supplies a medical device in Australia; and

(b) none of the following subparagraphs applies in relation to the

device:

(i) the device is of a kind included in the Register;

(ia) the device is of a kind covered by an exemption in force

under section 41GS;

(ii) the device is an exempt device;

(iii) the device is the subject of an approval under

section 41HB or an authority under section 41HC;

(iv) the device is the subject of an approval under

subsection 41HD(1) or (2) that is held by the person;

and

consumer of the device.

Penalty: 120 penalty units.

41ML False advertising about medical devices

A person commits an offence if:

(a) the person, by any means, advertises a medical device as

being for a purpose; and

(b) the device is of a kind included in the Register; and

inclusion.

Penalty: 60 penalty units.

41MLA Civil penalty for making misrepresentations about medical

devices

(1) A person contravenes this section if:

(a) the person makes a representation of a kind referred to in

subsection (2); and

(b) the representation is false or misleading.

Maximum civil penalty:

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Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 3 Medical devices not included in the Register and related matters

Section 41MM

374 Therapeutic Goods Act 1989

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

(2) Subsection (1) applies to the following representations:

(a) representations that medical devices are of a kind included in

the Register;

(b) representations that medical devices are exempt devices;

approval under section 41HB or an authority under

section 41HC;

(d) representations that medical devices are the subject of an

approval under subsection 41HD(1) or (2).

41MM Claims about arranging supplies of medical devices not

included in the Register

A person is guilty of an offence if:

(a) the person claims, by any means, that the person or another

person can arrange the supply of medical devices; and

(b) the devices are not:

(i) medical devices of a kind included in the Register; or

(ii) exempt devices.

Penalty: 60 penalty units.

41MN Criminal offences relating to breaches of conditions

Offences relating to breaching a condition of the inclusion of a

kind of medical device in the Register

(1) A person commits an offence if:

(a) a kind of medical device is included in the Register in

relation to the person; and

(b) the person does an act or omits to do an act; and

the kind of device in the Register; and

(d) the act or omission has resulted in, or will result in, harm or

injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

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Medical devices not included in the Register and related matters Division 3

Section 41MN

Therapeutic Goods Act 1989 375

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person commits an offence if:

(a) a kind of medical device is included in the Register in

relation to the person; and

(b) the person does an act or omits to do an act; and

the kind of device in the Register; and

(d) the act or omission is likely to result in harm or injury to any

person.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) a kind of medical device is included in the Register in

relation to the person; and

(b) the person does an act or omits to do an act; and

the kind of device in the Register.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Offences relating to breaching a condition of a conformity

assessment certificate

(5) A person commits an offence if:

(a) a conformity assessment certificate is issued in respect of the

person; and

(b) the person does an act or omits to do an act; and

assessment certificate; and

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Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 3 Medical devices not included in the Register and related matters

Section 41MN

376 Therapeutic Goods Act 1989

(d) the act or omission has resulted in, or will result in, harm or

injury to a person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

(6) A person commits an offence if:

(a) a conformity assessment certificate is issued in respect of the

person; and

(b) the person does an act or omits to do an act; and

assessment certificate; and

(d) the act or omission is likely to result in harm or injury to a

person.

Penalty: 2,000 penalty units.

(7) Subsection (6) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(8) A person commits an offence if:

(a) a conformity assessment certificate is issued in respect of the

person; and

(b) the person does an act or omits to do an act; and

assessment certificate.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Offence relating to breaching a condition of an exemption or

approval, or a condition applicable under regulations

(9) A person commits an offence if:

(a) the person does an act or omits to do an act; and

(b) the act or omission breaches:

(i) a condition of an exemption applicable under

regulations made for the purposes of section 41HA; or

(ii) a condition of an approval under section 41HB; or

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Section 41MNA

Therapeutic Goods Act 1989 377

(iii) a condition applicable under regulations made for the

purposes of subsection 41HB(7); or

(iv) a condition of an approval under subsection 41HD(1) or

(2).

Penalty: 60 penalty units.

41MNA Civil penalties for breaching conditions

(1) A person contravenes this subsection if:

(a) a kind of medical device is included in the Register in

relation to the person; and

(b) the person does an act or omits to do an act; and

the kind of device in the Register.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

(2) A person contravenes this subsection if:

(a) a conformity assessment certificate is issued in respect of the

person; and

(b) the person does an act or omits to do an act; and

assessment certificate.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

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Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 3A Offences and civil penalties related to exemptions under Part 4-6A

Section 41MNB

378 Therapeutic Goods Act 1989

Division 3A—Offences and civil penalties related to

exemptions under Part 4-6A

41MNB Criminal offences for breaching a condition of an

exemption

(1) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to a

medical device; and

(b) the device is of a kind covered by an exemption in force

under section 41GS; and

exemption; and

(d) the act or omission is likely to cause a serious risk to public

health.

Penalty: Imprisonment for 5 years or 2,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Strict liability applies to paragraph (1)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

(3) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to a

medical device; and

(b) the device is of a kind covered by an exemption in force

under section 41GS; and

exemption.

Penalty: Imprisonment for 4 years or 240 penalty units, or both.

(4) Strict liability applies to paragraph (3)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

(5) A person commits an offence if:

(a) the person does an act or omits to do an act in relation to a

medical device; and

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Offences and civil penalties related to exemptions under Part 4-6A Division 3A

Section 41MNC

Therapeutic Goods Act 1989 379

(b) the device is of a kind covered by an exemption in force

under section 41GS; and

exemption.

Penalty: 60 penalty units.

(6) An offence against subsection (5) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

41MNC Civil penalty for breaching a condition of an exemption

A person contravenes this section if:

(a) the person does an act or omits to do an act in relation to a

medical device; and

(b) the device is of a kind covered by an exemption in force

under section 41GS; and

exemption.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

41MND Civil penalty for making misrepresentations about medical

devices

A person contravenes this section if:

(a) the person makes a representation that medical devices are of

a kind covered by an exemption in force under section 41GS;

and

(b) the representation is false or misleading.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

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Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 4 Other offences and civil penalty provisions

Section 41MO

380 Therapeutic Goods Act 1989

Division 4—Other offences and civil penalty provisions

41MO Criminal offences for misusing medical devices exempted for

special or experimental uses

(1) A person commits an offence if:

(a) the person has been granted an authority under section 41HC

relating to a specified kind of medical device; and

(b) the person supplies a medical device of that kind:

(i) otherwise than in accordance with the authority; or

(ii) otherwise than in accordance with any conditions to

which the authority is subject; or

(iii) otherwise than in accordance with any regulations made

for the purpose of subsection 41HC(5); and

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the device, if the device were used, would

result in harm or injury to any person; and

(d) the harm or injury has resulted, will result, or would result,

because:

(i) the supply is not in accordance with the authority; or

(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 41HC(5).

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (4) instead: see section 53A.

(2) A person commits an offence if:

(a) the person has been granted an authority under section 41HC

relating to a specified kind of medical device; and

(b) the person supplies a medical device of that kind:

(i) otherwise than in accordance with the authority; or

(ii) otherwise than in accordance with any conditions to

which the authority is subject; or

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Other offences and civil penalty provisions Division 4

Section 41MO

Therapeutic Goods Act 1989 381

(iii) otherwise than in accordance with any regulations made

for the purpose of subsection 41HC(5); and

to result in harm or injury to any person; and

(d) the harm or injury would be likely to result because:

(i) the supply is not in accordance with the authority; or

(ii) the supply is not in accordance with the conditions to

which the authority is subject; or

(iii) the supply is not in accordance with regulations made

for the purpose of subsection 41HC(5).

Penalty: 2,000 penalty units.

(3) Subsection (2) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(4) A person commits an offence if:

(a) the person has been granted an authority under section 41HC

relating to a specified kind of medical device; and

(b) the person supplies a medical device of that kind:

(i) otherwise than in accordance with the authority; or

(ii) otherwise than in accordance with any conditions to

which the authority is subject; or

(iii) otherwise than in accordance with any regulations made

for the purpose of subsection 41HC(5).

Penalty: 500 penalty units.

(5) A person commits an offence if:

(a) the person has been granted an approval under section 41HB

relating to a specified medical device or specified kind of

medical device; and

(b) the person uses a medical device of that kind:

(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans;

otherwise than in accordance with the approval; and

(i) the use of the device has resulted in, or will result in,

harm or injury to any person; or

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 4 Other offences and civil penalty provisions

Section 41MP

382 Therapeutic Goods Act 1989

(ii) the use of the device, if the device were used, would

result in harm or injury to any person.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (8) instead: see section 53A.

(6) A person commits an offence if:

(a) the person has been granted an approval under section 41HB

relating to a specified medical device or specified kind of

medical device; and

(b) the person uses a medical device of that kind:

(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans;

otherwise than in accordance with the approval; and

to result in harm or injury to any person.

Penalty: 2,000 penalty units.

(7) Subsection (6) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(8) A person commits an offence if:

(a) the person has been granted an approval under section 41HB

relating to a specified medical device or specified kind of

medical device; and

(b) the person uses a medical device of that kind:

(i) in the treatment of another person; or

(ii) solely for experimental purposes in humans;

otherwise than in accordance with the approval.

Penalty: 500 penalty units.

41MP Criminal offence for failing to notify adverse events etc.

(1) A person is guilty of an offence if:

(a) the person is a person in relation to whom a kind of medical

device is included in the Register; and

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Other offences and civil penalty provisions Division 4

Section 41MP

Therapeutic Goods Act 1989 383

(b) the person knows that particular information is information

of a kind mentioned in subsection (2); and

within the period specified in the regulations (whether or not

the person has already given to the Secretary other

information relating to the same matter).

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) The information with which subsection (1) is concerned is

information of the following kinds:

(a) information relating to:

(i) any malfunction or deterioration in the characteristics or

performance of the kind of device; or

(ii) any inadequacy in the design, production, labelling,

instructions for use or advertising materials of the kind

of device; or

(iii) any use in accordance with, or contrary to, the use

intended by the manufacturer of the kind of device;

that might lead, or might have led, to the death of a patient or

a user of the device, or to a serious deterioration in his or her

state of health;

(b) information relating to any technical or medical reason for a

malfunction or deterioration of a kind referred to in

subparagraph (a)(i) that has led the manufacturer to take

steps to recover devices of that kind that have been

distributed;

comply with the essential principles;

(d) information that indicates that a certificate (other than one

issued under this Act) used for the purpose of an application

under subsection 41FC(1) to signify:

(i) compliance with the essential principles; or

(ii) the application of relevant conformity assessment

procedures to a particular device;

has been restricted, suspended, revoked or is no longer in

effect.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 4 Other offences and civil penalty provisions

Section 41MPA

384 Therapeutic Goods Act 1989

41MPA Civil penalty for failing to notify adverse events etc.

(1) A person contravenes this section if:

(a) a kind of medical device is included in the Register in

relation to the person; and

(b) the information is of a kind mentioned in subsection (2); and

subsection (2) to the Secretary within the period specified in

the regulations (whether or not the person has already given

to the Secretary other information relating to the same

matter).

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

(2) The information with which subsection (1) is concerned is

information of the following kinds:

(a) information relating to:

(i) any malfunction or deterioration in the characteristics or

performance of the kind of device; or

(ii) any inadequacy in the design, production, labelling,

instructions for use or advertising materials of the kind

of device; or

(iii) any use in accordance with, or contrary to, the use

intended by the manufacturer of the kind of device;

that might lead, or might have led, to the death of a patient or

user of the device, or to a serious deterioration in his or her

state of health;

(b) information relating to any technical or medical reason for a

malfunction or deterioration of a kind referred to in

subparagraph (a)(i) that has led the manufacturer to take

steps to recover devices of that kind that have been

distributed;

comply with the essential principles;

(d) information that indicates that a certificate (other than one

issued under this Act) used for the purpose of an application

under subsection 41FC(1) to signify:

(i) compliance with the essential principles; or

ComLaw Authoritative Act C2013C00132

Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Other offences and civil penalty provisions Division 4

Section 41MPB

Therapeutic Goods Act 1989 385

(ii) the application of relevant conformity assessment

procedures to a particular device;

has been restricted, suspended, revoked or is no longer in

effect.

41MPB Relief from liability for contraventions for failing to notify

adverse events etc.

(1) If:

(a) proceedings for the contravention of section 41MPA (a civil

penalty provision) are brought against a person; and

(b) in the proceedings it appears to the Court that the person has,

or may have, contravened that section but that:

(i) the person has a reasonable excuse; and

(ii) having regard to all the circumstances of the case, the

person ought fairly to be excused for the contravention;

the Court may relieve the person either wholly or partly from a

liability to which the person would otherwise be subject, or that

might otherwise be imposed on the person, because of the

contravention.

(2) If a person thinks that proceedings for the contravention of

section 41MPA will or may be begun against them, they may apply

to the Court for relief.

(3) On an application under subsection (2), the Court may grant relief

under subsection (1) as if proceedings had been begun in the Court.

(4) For the purposes of subsection (2) as applying for the purposes of a

case tried by a judge with a jury:

(a) a reference in that subsection to the Court is a reference to

the judge; and

(b) the relief that may be granted includes withdrawing the case

in whole or in part from the jury and directing judgment to be

entered for the person on such terms as to costs as the judge

thinks appropriate.

ComLaw Authoritative Act C2013C00132

Chapter 4 Medical devices

Part 4-11 Offences and civil penalty provisions relating to medical devices

Division 4 Other offences and civil penalty provisions

Section 41MQ

386 Therapeutic Goods Act 1989

41MQ Notification of adverse events etc. where application

withdrawn or lapses

(1) If an application for inclusion of a kind of medical device in the

applicant written notice requiring the applicant:

(a) to inform the Secretary in writing whether the applicant is

aware of any information of a kind mentioned in

subsection 41MP(2) or 41MPA(2) relating to the kind of

device; and

(b) if the applicant is aware of such information, to give the

information to the Secretary in writing.

(2) Notice under subsection (1) may only be given within 10 working

days after an application is withdrawn or lapses.

(3) A person is guilty of an offence if the person fails to comply with

the requirements of a notice under subsection (1) within 20

working days after the notice is given to the person.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(4) A person is guilty of an offence if:

(a) the person gives information in purported compliance with a

notice under this section; and

(b) the information is false or misleading in a material particular.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

41MR Civil penalties for failing to notify adverse effects etc. where

application withdrawn or lapses

Civil penalty for failing to comply with requirements of a notice

(1) A person contravenes this subsection if the person does not comply

with the requirements of a notice under subsection 41MQ(1) within

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Medical devices Chapter 4

Offences and civil penalty provisions relating to medical devices Part 4-11

Other offences and civil penalty provisions Division 4

Section 41MR

Therapeutic Goods Act 1989 387

20 working days after the day on which the notice is given to the

person.

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

Civil penalty for giving false or misleading information in

purported compliance with requirements of a notice

(2) A person contravenes this subsection if:

(a) the person gives information in purported compliance with a

notice under subsection 41MQ(1); and

(b) the information is false or misleading in a material particular.

Maximum civil penalty:

(a) for an individual—3,000 penalty units; and

(b) for a body corporate—30,000 penalty units.

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-1 Advertising and generic information

Division 1 Preliminary

Section 42AA

388 Therapeutic Goods Act 1989

Chapter 5—Advertising, counterfeit

therapeutic goods and product

tampering

Part 5-1—Advertising and generic information

Division 1—Preliminary

42AA This Part not to apply to advertisements directed at health

professionals etc.

(1) This Part does not apply to advertisements directed exclusively to:

(a) medical practitioners, psychologists, dentists, pharmacists,

optometrists, chiropractors, physiotherapists, nurses,

midwives, dental hygienists, dental prosthetists, dental

therapists or osteopaths; or

(b) persons who are:

(i) engaged in the business of wholesaling therapeutic

goods; or

(ii) purchasing officers in hospitals; or

nutritionists, practitioners of traditional Chinese medicine or

podiatrists registered under a law of a State or Territory; or

(d) a class of persons specified under subsection (1A).

(1A) The Minister may, by legislative instrument, specify a class of

persons for the purposes of paragraph (1)(d).

(2) This Part does not apply to advertisements directed exclusively to

persons who are members of an Australian branch (however

described) of one of the bodies prescribed for the purposes of this

subsection.

(3) For the purposes of subsection (2), a person is taken to be a

member of an Australian branch of one of those bodies if, and only

if, the person has the qualifications and training that are necessary

or appropriate for membership of the relevant body.

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Advertising and generic information Part 5-1

Preliminary Division 1

Section 42AB

Therapeutic Goods Act 1989 389

(4) This Part does not apply to advice or information given directly to

a patient by a person referred to in paragraph (1)(a) or (c) or

subsection (2) in the course of treatment of that patient.

42AB This Part not to apply to advertisements for goods not for

human use

This Part does not apply to advertisements in respect of goods that

are not for use in humans.

42AC This Part not to apply to advertisements for exported goods

(1) Subject to subsection (2), this Part does not apply to

advertisements solely for therapeutic goods that have been

exported or are intended exclusively for export.

(2) Section 42DKB applies to advertisements of that kind.

42B Definitions

In this Part, unless the contrary intention appears:

approval number means the distinguishing number allocated to an

approved advertisement by the Secretary under regulation 5J of the

Therapeutic Goods Regulations.

approved advertisement means an advertisement:

(a) approved under regulation 5G, or taken to be approved by the

Secretary under subregulation 5H(2), or approved by the

Minister on review under regulation 5M, of the Therapeutic

Goods Regulations; and

(b) the approval of which has not been withdrawn.

broadcaster, in relation to an advertisement for therapeutic goods,

means a person (other than a person who is required to enter those

goods on the Register) who undertakes, as a business activity in its

own right:

(a) the broadcasting of the advertisement in broadcast media; or

(b) the placement of the advertisement for such broadcasting.

broadcast media, in relation to an advertisement or generic

information, means any means (other than a means declared in the

regulations to be an exempted means) by which the information is

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-1 Advertising and generic information

Division 1 Preliminary

Section 42B

390 Therapeutic Goods Act 1989

disseminated electronically in a visible or audible form or a

combination of such forms.

generic information, in relation to therapeutic goods, includes any

statement, pictorial representation or design, however made, about

the composition, properties or other characteristics of therapeutic

goods, but does not include:

(a) an advertisement about the goods; or

(b) generic information included in an advertisement about the

goods; or

mainstream media means any magazine or newspaper for

consumers containing a range of news, public interest items,

advertorials, advertisements or competitions.

prohibited representation means a representation referred to in

subsection 42DJ(1).

publisher, in relation to an advertisement for therapeutic goods,

means a person (other than a person who is required to enter those

goods on the Register) who undertakes, as a business activity in its

own right:

(a) the publishing of the advertisement in specified media other

than broadcast media; or

(b) the placement of the advertisement for such publication.

publishing, in relation to an advertisement, includes inserting

material within the pages of an item of mainstream media.

required representation means a representation referred to in

subsection 42DJ(2).

restricted representation means a representation referred to in

section 42DD.

specified media, in relation to an advertisement or generic

information, means:

(a) mainstream media; or

(b) broadcast media; or

(d) displays about goods, including posters:

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Advertising and generic information Part 5-1

Preliminary Division 1

Section 42BAA

Therapeutic Goods Act 1989 391

(i) in shopping malls (except inside an individual shop);

and

(ii) in or on public transport; and

(iii) on billboards.

visual broadcast media means broadcast media that is intended to

be viewed by its audience.

42BAA Therapeutic Goods Advertising Code

The Minister may, by legislative instrument, make a code relating

to advertisements about therapeutic goods.

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-1 Advertising and generic information

Division 2 Therapeutic goods advertisements for which an approval is required

Section 42BA

392 Therapeutic Goods Act 1989

Division 2—Therapeutic goods advertisements for which

an approval is required

42BA Application of Division

This Division applies only to advertisements to which Part 2 of the

Therapeutic Goods Regulations applies.

42C Offences relating to publication of advertisements

(1) A person is guilty of an offence if:

(a) the person:

(i) publishes or broadcasts; or

(ii) causes to be published or broadcast;

in specified media, an advertisement that is required by the

Therapeutic Goods Regulations to be an approved

advertisement; and

(b) the advertisement is not an approved advertisement.

Penalty: 60 penalty units.

Note: Advertising that requires approval under Part 2 of the Therapeutic Goods Regulations 1990 must also comply with the Therapeutic Goods Advertising Code.

(2) A person is guilty of an offence if:

(a) the person:

(i) publishes or broadcasts; or

(ii) causes to be published or broadcast;

an advertisement in specified media; and

(b) the advertisement is not an approved advertisement in that it

differs, in any respect, from the advertisement that was

approved.

Penalty: 60 penalty units.

Note: Advertising that requires approval under Part 2 of the Therapeutic Goods Regulations 1990 must also comply with the Therapeutic Goods Advertising Code.

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Advertising and generic information Part 5-1

Therapeutic goods advertisements for which an approval is required Division 2

Section 42C

Therapeutic Goods Act 1989 393

(3) It is a defence to a prosecution under subsection (2) if:

(a) the person prosecuted is a publisher or broadcaster who

received the advertisement to which the prosecution relates

for publication or broadcasting in specified media in the

ordinary course of business; or

(b) the particular advertisement to which the prosecution relates

differs only in respect of a matter mentioned in

paragraph 5C(2)(b), (e) or (f) of the Therapeutic Goods

Regulations.

Note: A defendant bears an evidential burden in relation to the matters in subsection (3) (see subsection 13.3 of the Criminal Code).

(4) A person is guilty of an offence if:

(a) the person:

(i) publishes or broadcasts; or

(ii) causes to be published or broadcast;

a particular advertisement in specified media referred to in

paragraph (a), (c) or (d) of the definition of specified media;

and

(b) the advertisement:

(i) does not display its approval number; or

(ii) displays a number purporting to be its approval number

but that is not its approval number; or

(iii) displays an approval number that has expired.

Penalty: 30 penalty units.

Note: Advertising that requires approval under Part 2 of the Therapeutic Goods Regulations 1990 must also comply with the Therapeutic Goods Advertising Code.

(5) It is a defence to a prosecution under subsection (4) if the person

prosecuted:

(a) is a publisher who received the advertisement to which the

prosecution relates for publication in specified media referred

to in paragraph (a), (c) or (d) of the definition of specified

media; or

(b) is a broadcaster who received the advertisement to which the

prosecution relates for broadcasting in visual broadcast

media;

in the ordinary course of business.

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-1 Advertising and generic information

Division 2 Therapeutic goods advertisements for which an approval is required

Section 42C

394 Therapeutic Goods Act 1989

Note: A defendant bears an evidential burden in relation to the matters in subsection (5) (see subsection 13.3 of the Criminal Code).

(6) A person is guilty of an offence if:

(a) the person:

(i) publishes or broadcasts; or

(ii) causes to be published or broadcast;

in specified media, an approved advertisement; and

(b) the person’s action is in contravention of a condition to

which the approval of the advertisement is subject.

Penalty: 60 penalty units.

Note: Advertising that requires approval under Part 2 of the Therapeutic Goods Regulations 1990 must also comply with the Therapeutic Goods Advertising Code.

(7) It is a defence to a prosecution under subsection (6) if the person

prosecuted is a publisher or broadcaster who received the

advertisement to which the prosecution relates for publication or

broadcasting in specified media in the ordinary course of business.

Note: A defendant bears an evidential burden in relation to the matters in subsection (7) (see subsection 13.3 of the Criminal Code).

(8) An offence against this section is an offence of strict liability.

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Advertising and generic information Part 5-1

General provisions about advertising therapeutic goods Division 3

Section 42DA

Therapeutic Goods Act 1989 395

Division 3—General provisions about advertising

therapeutic goods

42DA Simplified outline

The following is a simplified outline of this Division:

This Division has 2 kinds of application.

First, Part 2 of the Therapeutic Goods Regulations 1990 deals with

the Secretary approving certain advertisements and it refers to

provisions of this Division.

Second, the offences in Division 3A of this Part refer to provisions

of this Division.

42DB Definitions

In this Division:

applicant means an applicant for approval of the use of a restricted

representation in an advertisement about therapeutic goods.

approval holder, in relation to a restricted representation, means

the person to whom notice of approval of the use of the restricted

representation was given.

42DD Restricted representations

For the purposes of this Part, a representation in an advertisement

about therapeutic goods that refers to a form of a disease,

condition, ailment or defect identified in a part of the Therapeutic

Goods Advertising Code as a serious form of a disease, condition,

ailment or defect is a restricted representation about therapeutic

goods.

Note: Under subsection 42DL(1) it is an offence for a person to publish or broadcast an advertisement about therapeutic goods that contains a restricted representation, about those goods, the use of which has not been approved under subsection 42DF(1) or permitted under subsection 42DK(1).

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-1 Advertising and generic information

Division 3 General provisions about advertising therapeutic goods

Section 42DE

396 Therapeutic Goods Act 1989

42DE Applications for approval of use of restricted representation

An application for approval of the use of a restricted representation

must be:

(a) made to the Secretary in writing, in a form approved by the

Secretary; and

(b) signed by or on behalf of the applicant.

42DF Approval of use of restricted representation

(1) If an application for approval of the use of a restricted

representation is made, the Secretary must approve the use of the

restricted representation if the Secretary is satisfied that:

(a) the representation is accurate and balanced; and

(b) the representation is not misleading or likely to be

misleading.

(2) Otherwise, the Secretary must refuse to approve the use of the

restricted representation.

(3) An approval may be subject to conditions imposed by the

Secretary.

(4) In deciding whether to approve or refuse to approve the use of a

restricted representation, the Secretary must take into

consideration:

(a) any recommendation of the Therapeutic Goods Advertising

Code Council; and

(b) any advice of a committee that is established under the

regulations and is prescribed by the regulations for the

purposes of this paragraph; and

Therapeutic Goods Advertising Code dealing with restricted

representations.

42DG Notice of approval or refusal

(1) The Secretary must give written notice to the applicant of the

approval of, or of the refusal to approve, the use of a restricted

representation.

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Advertising and generic information Part 5-1

General provisions about advertising therapeutic goods Division 3

Section 42DH

Therapeutic Goods Act 1989 397

(2) If written notice is not given to the applicant within the period of

60 days after the day on which the application was made (or within

such longer period as the Secretary specifies by written notice to

the applicant before the end of that period), the Secretary is taken

to have approved the use of the restricted representation at the end

of the period.

(3) If an approval is subject to conditions, the conditions must be set

out in the notice.

(4) A notice of refusal to approve the use of a restricted representation

must:

(a) give the Secretary’s reasons for the refusal; and

(b) inform the applicant of the applicant’s right to have the

Secretary’s decision reviewed by the Minister under

section 60.

42DH Variation of conditions of approval

(1) The Secretary, by written notice to an approval holder, may vary

any condition of approval of the use of a restricted representation.

(2) The notice must:

(a) give the Secretary’s reasons for the variation; and

(b) inform the approval holder of the approval holder’s right to

have the Secretary’s decision reviewed by the Minister under

section 60.

42DI Withdrawal of approval

(1) The Secretary, by written notice, may withdraw the approval of the

use of a restricted representation if:

(a) the Secretary is satisfied that:

(i) information given by the applicant in the application

was false or incorrect and the Secretary, or the Minister

on review of a decision of the Secretary under

section 42DF or 42DH, relied on the information in

deciding to approve the use of the representation; or

(ii) the restricted representation has become a prohibited

representation; or

(iii) there has been a breach of a condition of approval; or

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-1 Advertising and generic information

Division 3 General provisions about advertising therapeutic goods

Section 42DJ

398 Therapeutic Goods Act 1989

(b) both:

(i) additional information about the safety of the

therapeutic goods becomes available; and

(ii) the Secretary is satisfied that, if that information had

been available at the time of the approval, the Secretary

would not have approved the use of the restricted

representation.

(2) The notice must:

(a) give the Secretary’s reasons for the withdrawal; and

(b) inform the approval holder of the approval holder’s right to

have the Secretary’s decision reviewed by the Minister under

section 60.

42DJ Prohibited and required representations

(1) For the purposes of this Part, representations of a kind specified in

regulations made for the purposes of this subsection are prohibited

representations about therapeutic goods of a kind specified in those

regulations.

(2) For the purposes of this Part, representations of a kind specified in

regulations made for the purposes of this subsection are required

representations about the therapeutic goods of a kind specified in

those regulations.

42DK Use of restricted or prohibited representations

(1) The Secretary may, by notice in writing published in the Gazette or

on the Department’s website, permit, in relation to therapeutic

goods, the use of a restricted representation (including its use on

the label of the goods or in information included in the package in

which the goods are contained).

(2) The Secretary may, by notice in writing published in the Gazette or

on the Department’s website, permit a prohibited representation to

be included on the label of therapeutic goods, or in information

included in the package in which therapeutic goods are contained,

if the representation is necessary for the appropriate use of the

goods.

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Advertising and generic information Part 5-1

Therapeutic goods advertisements for which an approval is not required Division 3A

Section 42DKA

Therapeutic Goods Act 1989 399

Division 3A—Therapeutic goods advertisements for which

an approval is not required

42DKA Application of Division

This Division applies to advertisements about therapeutic goods

other than advertisements for which an approval is required under

Part 2 of the Therapeutic Goods Regulations 1990.

42DKB Certain representations not to be published or broadcast

(1) If a representation in an advertisement about therapeutic goods is

false or misleading, the Secretary may, by notice given to the

person apparently responsible for publishing or broadcasting the

advertisement, prevent that person from publishing or

broadcasting, or causing to be published or broadcast, an

advertisement containing that representation (whether express or

implied) about those goods.

(2) A notice under subsection (1) is not a legislative instrument.

42DL Advertising offences

(1) A person must not publish or broadcast an advertisement about

therapeutic goods:

(a) that contains a prohibited representation (whether in express

terms or by necessary implication) about those goods; or

(b) that does not contain a required representation about those

goods; or

the use of which has not been approved under

subsection 42DF(1) or permitted under subsection 42DK(1);

(d) that is in contravention of a notice referred to in

section 42DKB that was given to the person; or

(e) that contains:

(i) a reference to the Act other than in a statement of the

registration number, listing number or device number of

the goods; or

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-1 Advertising and generic information

Division 3A Therapeutic goods advertisements for which an approval is not required

Section 42DL

400 Therapeutic Goods Act 1989

(ii) a statement suggesting or implying the goods have been

recommended or approved by or on behalf of a

government or government authority (including a

foreign government or foreign government authority),

other than a statement of their availability as a

pharmaceutical benefit or a statement authorised or

required by a government or government authority

(including a foreign government or foreign government

authority); or

(f) that contains a statement referring to goods, or substances or

preparations containing goods, included in Schedule 3, 4 or 8

to the current Poisons Standard, other than a statement

authorised or required by a government or government

authority (including a foreign government or foreign

government authority); or

(fa) that contains a statement referring to a biological, other than

a statement authorised or required by a government or

government authority (including a foreign government or

foreign government authority); or

(g) that are not entered in the Register; or

(h) if the goods are therapeutic goods, or come within a class of

therapeutic goods, that:

(i) are exempt goods or exempt devices prescribed in the

regulations for the purposes of this provision; or

(ii) have been approved under subsection 19(1) or

section 41HB of this Act for importation into,

exportation from, or supply within, Australia.

Penalty: 60 penalty units.

(2) For the purposes of an offence against subsection (1), strict liability

applies to the following physical elements:

(a) that the use of a restricted representation, as referred to in

paragraph (1)(c), has not been approved under

subsection 42DF(1) or permitted under subsection 42DK(1);

(b) that the notice referred to in paragraph (1)(d) is a notice

referred to in section 42DKB;

paragraph (1)(f) are included in Schedule 3, 4 or 8 to the

current Poisons Standard;

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Advertising and generic information Part 5-1

Therapeutic goods advertisements for which an approval is not required Division 3A

Section 42DM

Therapeutic Goods Act 1989 401

(d) that the therapeutic goods, or class of therapeutic goods,

referred to in paragraph (1)(h):

(i) are exempt goods or exempt devices prescribed in the

regulations made for the purposes of

subparagraph (1)(h)(i); or

(ii) have been approved under subsection 19(1) or

section 41HB of the Act for importation into,

exportation from or supply within, Australia.

(3) It is a defence to a prosecution under subsection (1) if:

(a) in relation to an advertisement mentioned in paragraph (1)(a)

or (f)—the advertisement is made by, or on behalf of, the

Commonwealth; and

(b) in relation to an advertisement mentioned in

paragraph (1)(f)—the goods, substances or preparations are

mentioned in Appendix H of the current Poisons Standard;

and

goods are exempt goods or exempt devices other than goods

of a kind mentioned in paragraph (1)(h).

Note: A defendant bears an evidential burden in relation to the matters mentioned in subsection (3) (see section 13.3 of the Criminal Code).

42DM Compliance with Code

(1) A person is guilty of an offence if:

(a) the person publishes or broadcasts an advertisement about

therapeutic goods; and

(b) the advertisement does not comply with the Therapeutic

Goods Advertising Code.

Penalty: 60 penalty units.

(2) An offence against this section is an offence of strict liability.

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-1 Advertising and generic information

Division 4 Generic information about ingredients or components of therapeutic goods

Section 42DN

402 Therapeutic Goods Act 1989

Division 4—Generic information about ingredients or

components of therapeutic goods

42DN Application of Division

This Division applies to generic information about goods that:

(a) may be used as an ingredient or component in the

manufacture of therapeutic goods; and

(b) although not presented for supply as therapeutic goods, come

within the meaning of therapeutic goods because they are

represented to be:

(i) for therapeutic use; or

(ii) for use as an ingredient or component in the

manufacture of other therapeutic goods.

42DO Compliance with the Code

Generic information to which this Division applies must comply

with principles of the Therapeutic Goods Advertising Code

specified in regulations made for the purposes of this section as if

those principles applied to generic information in the same way as

they apply to advertisements.

42DP Offences—publication of generic information

(1) A person is guilty of an offence if:

(a) the person publishes or broadcasts generic information about

therapeutic goods; and

(b) the publication or broadcasting of that generic information

does not comply with principles contained in the part of the

Therapeutic Goods Advertising Code that are specified in

Regulations.

Penalty: 60 penalty units.

(2) An offence against this section is an offence of strict liability.

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Counterfeit therapeutic goods Part 5-2

Section 42E

Therapeutic Goods Act 1989 403

Part 5-2—Counterfeit therapeutic goods

42E Offence of dealing with counterfeit therapeutic goods

(1) A person is guilty of an offence if:

(a) the person intentionally:

(i) manufactures goods in Australia; or

(ii) supplies goods in Australia; or

(iii) imports goods into Australia; or

(iv) exports goods from Australia; and

(b) the goods are therapeutic goods; and

reckless as to whether that fact exists.

Penalty: 7 years imprisonment or 2,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Goods are counterfeit if any of the following contain a false

representation of a matter listed in subsection (3):

(a) the label or presentation of the goods;

(b) any document or record relating to the goods or their

manufacture;

(3) The matters are as follows:

(a) the identity or name of the goods;

(b) the formulation, composition or design specification of the

goods or of any ingredient or component of them;

the goods;

(d) the strength or size of the goods (other than the size of any

pack in which the goods are contained);

(e) the strength or size of any ingredient or component of the

goods;

(f) the sponsor, source, manufacturer or place of manufacture of

the goods.

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-2 Counterfeit therapeutic goods

Section 42EA

404 Therapeutic Goods Act 1989

(5) To avoid doubt, a term that is defined in subsection 3(1) in relation

to therapeutic goods and used in this section in relation to goods

has in this section the meaning given by subsection 3(1).

42EA Civil penalty relating to dealing with counterfeit therapeutic

goods

A person contravenes this section if:

(a) the person does any of the following:

(i) manufactures goods in Australia;

(ii) supplies goods in Australia;

(iii) imports goods into Australia;

(iv) exports goods from Australia; and

(b) the goods are therapeutic goods; and

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

42EB Relief from liability for certain contraventions relating to

dealing with counterfeit therapeutic goods

(1) If:

(a) proceedings for the contravention of section 42EA (a civil

penalty provision) are brought against a person; and

(b) in the proceedings it appears to the Court that the person has,

or may have, contravened that section but that:

(i) the person has a reasonable excuse; and

(ii) having regard to all the circumstances of the case, the

person ought fairly to be excused for the contravention;

the Court may relieve the person either wholly or partly from a

liability to which the person would otherwise be subject, or that

might otherwise be imposed on the person, because of the

contravention.

(2) If a person thinks that proceedings for the contravention of

section 42EA will or may be begun against them, they may apply

to the Court for relief.

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Counterfeit therapeutic goods Part 5-2

Section 42F

Therapeutic Goods Act 1989 405

(3) On an application under subsection (2), the Court may grant relief

under subsection (1) as if proceedings had been begun in the Court.

(4) For the purposes of subsection (2) as applying for the purposes of a

case tried by a judge with a jury:

(a) a reference in that subsection to the Court is a reference to

the judge; and

(b) the relief that may be granted includes withdrawing the case

in whole or in part from the jury and directing judgment to be

entered for the person on such terms as to costs as the judge

thinks appropriate.

Exception

(5) This section does not apply to civil proceedings against a person

for manufacturing therapeutic goods in Australia that are

counterfeit (see subparagraph 42EA(a)(i)).

42F Customs treatment of counterfeit therapeutic goods

Imported counterfeit therapeutic goods

(1) If the Secretary notifies the Chief Executive Officer of Customs in

writing that the Secretary wishes the Customs Act 1901 to apply to

an import of counterfeit therapeutic goods, that Act has effect as if

the goods included in the import were goods described as forfeited

to the Crown under section 229 of that Act because they were

prohibited imports within the meaning of that Act.

Exported counterfeit therapeutic goods

(2) If the Secretary notifies the Chief Executive Officer of Customs in

writing that the Secretary wishes the Customs Act 1901 to apply to

an export of counterfeit therapeutic goods, that Act has effect as if

the goods included in the export were goods described as forfeited

to the Crown under section 229 of that Act because they were

prohibited exports within the meaning of that Act.

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-3 Product tampering

Section 42T

406 Therapeutic Goods Act 1989

Part 5-3—Product tampering

42T Notifying of actual or potential tampering

(1) A person is guilty of an offence if:

(a) the person supplies, manufactures or is a sponsor of, or

proposes to supply, manufacture or become a sponsor of,

therapeutic goods; and

(b) either:

(i) the person knows that some or all of those therapeutic

goods, or any other therapeutic goods, are or have been

subject to actual or potential tampering; or

(ii) some or all of those therapeutic goods, or any other

therapeutic goods, are or have been subject to actual or

potential tampering, and the person is reckless as to that

fact; and

becoming aware of a substantial risk of, the actual or

potential tampering, to notify the Secretary or the National

Manager of the Therapeutic Goods Administration.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person is guilty of an offence if:

(a) the person supplies, manufactures or is a sponsor of, or

proposes to supply, manufacture or become a sponsor of,

therapeutic goods; and

(b) the person receives information or a demand; and

(i) the person knows that the information or demand relates

(either expressly or by implication) to actual or potential

tampering with some or all of those therapeutic goods,

or any other therapeutic goods; or

(ii) the information or demand relates (either expressly or

by implication) to actual or potential tampering with

some or all of those therapeutic goods, or any other

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Product tampering Part 5-3

Section 42U

Therapeutic Goods Act 1989 407

therapeutic goods, and the person is negligent as to that

fact; and

(d) the person fails to notify the Secretary or the National

Manager of the Therapeutic Goods Administration of the

information or demand within 24 hours after receiving it.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(3) For the purposes of subparagraph (2)(c)(ii), the person is only

taken to be negligent as to the fact that the information or demand

is of the kind referred to in that subparagraph if:

(a) the person’s acts or omissions involve such a great falling

short of the standard of care that a reasonable person would

exercise in the circumstances; and

(b) there is such a high risk that the information or demand is of

that kind;

that the acts or omissions merit criminal punishment.

(4) For the purposes of this section, it does not matter whether, at the

time of receipt of the information or demand:

(a) the person has possession or control of the therapeutic goods

to which the information or demand relates; or

(b) the therapeutic goods are in existence.

42U Meaning of actual or potential tampering etc.

Actual or potential tampering, in relation to therapeutic goods,

means:

(a) tampering with the therapeutic goods; or

(b) causing the therapeutic goods to be tampered with; or

(d) proposing to cause the therapeutic goods to be tampered

with.

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-3 Product tampering

Section 42V

408 Therapeutic Goods Act 1989

42V Recovery of therapeutic goods because of actual or potential

tampering

(1) The Secretary may, in writing, impose requirements under this

section on a person if:

(a) the person supplies or has supplied therapeutic goods of a

particular kind, or a particular batch of therapeutic goods of

that kind; and

(b) the Secretary is satisfied that therapeutic goods of that kind,

or included in that batch, are, have been or could possibly be,

subject to actual or potential tampering.

(2) The requirements may be one or more of the following:

(a) to take specified steps, in the specified manner and within

such reasonable period as is specified, to recover therapeutic

goods of that kind, or included in that batch, that the person

has supplied;

(b) to inform the public or a specified class of persons, in the

specified manner and within such reasonable period as is

specified, that therapeutic goods of that kind, or included in

that batch, are, or have been, subject to actual or potential

tampering;

specified manner and within such reasonable period as is

specified, that therapeutic goods of that kind, or included in

that batch, could possibly be subject to actual or potential

tampering.

(3) Requirements referred to in paragraph (2)(a) do not apply to

therapeutic goods that cannot be recovered because they have been

administered to, or applied in the treatment of, a person.

(4) The Secretary must cause to be published in the Gazette, as soon as

practicable after imposing such requirements, a notice setting out

particulars of the requirements.

(5) The Secretary may impose requirements under this section whether

or not the Secretary has been notified under section 42T.

(6) A person commits an offence if:

(a) the person fails to comply with a requirement under

subsection (1) in relation to a supply of therapeutic goods;

and

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Product tampering Part 5-3

Section 42V

Therapeutic Goods Act 1989 409

(b) either:

(i) the use of the goods has resulted in, or will result in,

harm or injury to any person; or

(ii) the use of the goods, if the goods were used, would

result in harm or injury to any person; and

because the person failed to comply with the requirement.

Penalty: Imprisonment for 5 years or 4,000 penalty units, or both.

Note 1: A jury may acquit a person of an offence against this subsection and may convict the person of an offence against subsection (6C) instead: see section 53A.

Note 2: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(6A) A person commits an offence if:

(a) the person fails to comply with a requirement under

subsection (1) in relation to a supply of therapeutic goods;

and

(b) the use of the goods, if the goods were used, would be likely

to result in harm or injury to any person; and

person failed to comply with the requirement.

Penalty: 2,000 penalty units.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(6B) Subsection (6A) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

(6C) A person commits an offence if the person fails to comply with a

requirement under subsection (1) in relation to a supply of

therapeutic goods.

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

(7) This section does not prevent the Secretary from taking action

under section 29D or 30, Division 6 or 7 of Part 3-2A or Division 1

or 2 of Part 4-6.

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-3 Product tampering

Section 42VA

410 Therapeutic Goods Act 1989

42VA Civil penalty relating to the recovery of therapeutic goods

because of actual or potential tampering

A person contravenes this section if the person fails to comply with

a requirement under subsection 42V(1) in relation to a supply of

therapeutic goods.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

42VB Relief from liability for contraventions relating to the

recovery of therapeutic goods because of actual or

potential tampering

(1) If:

(a) proceedings for the contravention of section 42VA (a civil

penalty provision) are brought against a person; and

(b) in the proceedings it appears to the Court that the person has,

or may have, contravened that section but that:

(i) the person has acted honestly; and

(ii) having regard to all the circumstances of the case, the

person ought fairly to be excused for the contravention;

the Court may relieve the person either wholly or partly from a

liability to which the person would otherwise be subject, or that

might otherwise be imposed on the person, because of the

contravention.

(2) If a person thinks that proceedings for the contravention of

section 42VA will or may be begun against them, they may apply

to the Court for relief.

(3) On an application under subsection (2), the Court may grant relief

under subsection (1) as if proceedings had been begun in the Court.

(4) For the purposes of subsection (2) as applying for the purposes of a

case tried by a judge with a jury:

(a) a reference in that subsection to the Court is a reference to

the judge; and

(b) the relief that may be granted includes withdrawing the case

in whole or in part from the jury and directing judgment to be

ComLaw Authoritative Act C2013C00132

Advertising, counterfeit therapeutic goods and product tampering Chapter 5

Product tampering Part 5-3

Section 42W

Therapeutic Goods Act 1989 411

entered for the person on such terms as to costs as the judge

thinks appropriate.

42W Supply etc. of therapeutic goods that are subject to recovery

requirements

(1) A person is guilty of an offence if:

(a) the person supplies therapeutic goods in Australia; and

(b) either:

(i) the person knows that the therapeutic goods are of a

kind, or are included in a batch, in respect of which

requirements have been imposed under section 42V, on

that person or another person, to recover therapeutic

goods; or

(ii) the therapeutic goods are of such a kind, or are included

in such a batch, and the person is reckless as to that fact;

and

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) A person is guilty of an offence if:

(a) the person exports therapeutic goods from Australia; and

(b) either:

(i) the person knows that the therapeutic goods are of a

kind, or are included in a batch, in respect of which

requirements have been imposed under section 42V, on

that person or another person, to recover therapeutic

goods; or

(ii) the therapeutic goods are of such a kind, or are included

in such a batch, and the person is reckless as to that fact;

and

Penalty: Imprisonment for 12 months or 1,000 penalty units, or

both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

ComLaw Authoritative Act C2013C00132

Chapter 5 Advertising, counterfeit therapeutic goods and product tampering

Part 5-3 Product tampering

Section 42X

412 Therapeutic Goods Act 1989

(3) The Secretary must not give consent relating to an exportation

unless satisfied that there are exceptional circumstances that justify

giving the consent.

42X Saving of other laws

This Part is not intended to exclude or limit the operation of any

other law of the Commonwealth or any law of a State or Territory.

ComLaw Authoritative Act C2013C00132

Enforcement Chapter 5A

Civil penalties Part 5A-1

Obtaining an order for a civil penalty Division 1

Section 42Y

Therapeutic Goods Act 1989 413

Chapter 5A—Enforcement

Part 5A-1—Civil penalties

Division 1—Obtaining an order for a civil penalty

42Y Federal Court may order person to pay pecuniary penalty for

contravening civil penalty provision

Application for order

(1) Within 6 years of a person (the wrongdoer) contravening a civil

penalty provision, the Secretary may apply on behalf of the

Commonwealth to the Federal Court for an order that the

wrongdoer pay the Commonwealth a pecuniary penalty.

Court may order wrongdoer to pay pecuniary penalty

(2) If the Court is satisfied that the wrongdoer has contravened a civil

penalty provision, the Court may order the wrongdoer to pay to the

Commonwealth for each contravention the pecuniary penalty that

the Court determines is appropriate (but not more than the

maximum amount specified for the provision).

Determining amount of pecuniary penalty

(3) In determining the pecuniary penalty, the Court must have regard

to all relevant matters, including:

(a) the nature and extent of the contravention; and

(b) the nature and extent of any loss or damage suffered as a

result of the contravention; and

(d) whether the person has previously been found by the Court in

proceedings under this Act to have engaged in any similar

conduct.

Civil evidence and procedure rules apply

(4) The Court must apply the rules of evidence and procedure for civil

matters when hearing and determining an application for an order

under this section.

ComLaw Authoritative Act C2013C00132

Chapter 5A Enforcement

Part 5A-1 Civil penalties

Division 1 Obtaining an order for a civil penalty

Section 42YA

414 Therapeutic Goods Act 1989

Note: The standard of proof in civil proceedings is the balance of probabilities: see section 140 of the Evidence Act 1995.

Conduct contravening more than one civil penalty provision

(5) If conduct constitutes a contravention of 2 or more civil penalty

provisions, proceedings may be instituted under this Act against a

person in relation to the contravention of any one or more of those

provisions. However, the person is not liable to more than one

pecuniary penalty under this section in respect of the same

conduct.

42YA What is a civil penalty provision?

A subsection of this Act (or a section of this Act that is not divided

into subsections) is a civil penalty provision if the words ―civil

penalty‖ and one or more amounts in penalty units are set out at the

foot of the subsection (or section).

42YB Meaning of penalty unit

In this Act, penalty unit, in relation to a civil penalty provision, has

the same meaning as given by section 4AA of the Crimes Act

1914.

42YC Persons involved in contravening civil penalty provision

(1) A person must not:

(a) aid, abet, counsel or procure a contravention of a civil

penalty provision; or

(b) induce (by threats, promises or otherwise) a contravention of

a civil penalty provision; or

(2) This Act applies to a person who contravenes subsection (1) in

relation to a civil penalty provision as if the person had

contravened the civil penalty provision.

42YD Recovery of a pecuniary penalty

If the Federal Court orders a person to pay a pecuniary penalty:

(a) the penalty is payable to the Commonwealth; and

ComLaw Authoritative Act C2013C00132

Enforcement Chapter 5A

Civil penalties Part 5A-1

Obtaining an order for a civil penalty Division 1

Section 42YE

Therapeutic Goods Act 1989 415

(b) the Commonwealth may enforce the order as if it were a

judgment of the Court.

42YE Gathering information for application for pecuniary penalty

(1) This section applies if it appears to the Secretary that a person (the

wrongdoer) may have contravened a civil penalty provision.

(2) If the Secretary, on reasonable grounds, suspects that a person

other than the wrongdoer can give information relevant to an

application for a civil penalty order in relation to the contravention,

whether or not such an application has been made, the Secretary

may, by writing given to the person, require the person to give all

reasonable assistance in connection with such an application.

(3) Subsection (2) does not apply in relation to a duly qualified legal

practitioner who is acting, or has acted, for the wrongdoer.

(4) If a person fails to give assistance as required under subsection (2),

the Federal Court may, on the application of the Secretary, order

the person to comply with the requirement as specified in the order.

(5) If a person fails to give assistance as required under subsection (2),

the person commits an offence against this subsection.

Penalty: 30 penalty units.

ComLaw Authoritative Act C2013C00132

Chapter 5A Enforcement

Part 5A-1 Civil penalties

Division 2 Civil penalty proceedings and criminal proceedings

Section 42YF

416 Therapeutic Goods Act 1989

Division 2—Civil penalty proceedings and criminal

proceedings

42YF Civil proceedings after criminal proceedings

The Federal Court must not make a pecuniary penalty order against

a person for a contravention of a civil penalty provision if the

person has been convicted of an offence constituted by conduct

that is substantially the same as the conduct constituting the

contravention.

42YG Criminal proceedings during civil proceedings

(1) Proceedings for a pecuniary penalty order against a person for a

contravention of a civil penalty provision are stayed if:

(a) criminal proceedings are started or have already been started

against the person for an offence; and

(b) the offence is constituted by conduct that is substantially the

same as the conduct alleged to constitute the contravention.

(2) The proceedings for the order may be resumed if the person is not

convicted of the offence. Otherwise, the proceedings for the order

are dismissed.

42YH Criminal proceedings after civil proceedings

Criminal proceedings may not be started against a person for

conduct that is substantially the same as conduct constituting a

contravention of a civil penalty provision if a pecuniary penalty

order has been made against the person in respect of that conduct.

42YI Evidence given in proceedings for civil penalty not admissible

in criminal proceedings

Evidence of information given or evidence of production of

documents by an individual is not admissible in criminal

proceedings against the individual if:

(a) the individual previously gave the evidence or produced the

documents in proceedings for a pecuniary penalty order

against the individual for a contravention of a civil penalty

provision (whether or not the order was made); and

ComLaw Authoritative Act C2013C00132

Enforcement Chapter 5A

Civil penalties Part 5A-1

Civil penalty proceedings and criminal proceedings Division 2

Section 42YI

Therapeutic Goods Act 1989 417

(b) the conduct alleged to constitute the offence is substantially

the same as the conduct that was claimed to constitute the

contravention.

However, this does not apply to a criminal proceeding in respect of

the falsity of the evidence given by the individual in the

proceedings for the pecuniary penalty order.

ComLaw Authoritative Act C2013C00132

Chapter 5A Enforcement

Part 5A-2 Infringement notices

Section 42YJ

418 Therapeutic Goods Act 1989

Part 5A-2—Infringement notices

42YJ Infringement notices in respect of offences

(1) The regulations may make provision enabling a person who is

alleged to have committed an offence against this Act to pay to the

Commonwealth, as an alternative to prosecution, a specified

penalty.

Note: An offence against this Act includes an offence against the regulations: see subsection 3(7).

(2) If an individual is alleged to have committed an offence against

this Act, the penalty must not exceed an amount equal to one-fifth

of the maximum penalty that could have been imposed on the

individual for that offence.

(3) If a body corporate is alleged to have committed an offence against

this Act, the penalty must not exceed an amount equal to 5 times

the amount specified under subsection (2) in relation to that

offence.

42YK Infringement notices in respect of civil penalty provisions

(1) The regulations may make provision enabling a person who is

alleged to have contravened a civil penalty provision to pay to the

Commonwealth, as an alternative to civil penalty proceedings

against the person, a specified penalty.

(2) The penalty must not exceed an amount equal to one-tenth of the

maximum penalty prescribed for contravening that provision.

ComLaw Authoritative Act C2013C00132

Enforcement Chapter 5A

Enforceable undertakings Part 5A-3

Section 42YL

Therapeutic Goods Act 1989 419

Part 5A-3—Enforceable undertakings

42YL Enforcement of undertakings

(1) The Secretary may accept a written undertaking given by a person

in connection with a matter in relation to which the Secretary has a

power or function under this Act or the regulations.

(2) The person may withdraw or vary the undertaking at any time, but

only with the consent of the Secretary.

(3) The Secretary must publish details of the undertaking, as in force

from time to time, on the internet.

(4) If the Secretary considers that the person who gave the undertaking

has breached any of its terms, the Secretary may apply to the

Federal Court for an order under subsection (5).

(5) If the Court is satisfied that the person has breached a term of the

undertaking, the Court may make all or any of the following

orders:

(a) an order directing the person to comply with that term of the

undertaking;

(b) an order directing the person to pay to the Commonwealth an

amount up to the amount of any financial benefit that the

person has obtained directly or indirectly and that is

reasonably attributable to the breach;

person to compensate any other person who has suffered loss

or damage as a result of the breach;

(d) any other order that the Court considers appropriate.

ComLaw Authoritative Act C2013C00132

Chapter 6 Administration

Part 6-1 Payment of charges

Section 43

420 Therapeutic Goods Act 1989

Chapter 6—Administration

Part 6-1—Payment of charges

43 By whom charges payable

(1) An annual registration charge, annual listing charge or annual

charge for inclusion in the Register is payable by the person in

relation to whom the therapeutic goods concerned are registered,

listed or included in the Register.

(2) An annual licensing charge is payable by the holder of the licence

to which the charge relates.

44 Time for payment of charges

Annual registration charge, annual listing charge or annual

charge for inclusion in the Register

(1) An annual registration charge, annual listing charge or annual

charge for inclusion in the Register for a financial year becomes

payable:

(a) if the registration, listing or inclusion in the Register of the

therapeutic goods concerned commenced in that financial

year—on the day worked out under the regulations; and

(b) in any other case:

(i) on 1 October in that year; or

(ii) if the regulations specify another day for the purposes of

this subparagraph—on that other day in that year.

This subsection is subject to subsection (3).

Annual licensing charge

(2) An annual licensing charge for a financial year becomes payable:

(a) if the licence commenced in that financial year—on the day

of that commencement; and

(b) in any other case:

(i) on 1 October in that year; or

(ii) if the regulations specify another day for the purposes of

this subparagraph—on that other day in that year.

ComLaw Authoritative Act C2013C00132

Administration Chapter 6

Payment of charges Part 6-1

Section 44A

Therapeutic Goods Act 1989 421

This subsection is subject to subsection (3).

Charge may become payable on a later day

(3) The Secretary may, by notice in writing given to a person, specify

a later day on which a charge referred to in subsection (1) or (2)

becomes payable by the person for a financial year. The notice has

effect accordingly.

Interpretation

(4) This section is subject to section 44A.

44A Exemptions from liability to pay charges

(1) The regulations may make provision for and in relation to:

(a) exempting a person from liability to pay annual registration

charge, annual listing charge or annual charge for inclusion

in the Register for a financial year (the current year) if the

person’s turnover of the therapeutic goods concerned for the

financial year specified in the regulations is of low value; and

(b) the making of an application for an exemption and requiring

payment of that charge for the current year if the application

is refused; and

charge for the current year.

Fees

(2) The regulations may require applications for exemptions to be

accompanied by a specified fee. A fee must not be such as to

amount to taxation.

Statements prepared by approved persons

(3) The regulations may require a person who is applying for an

exemption, or who has been granted an exemption, to provide a

statement:

(a) that is prepared by an approved person; and

(b) that specifies whether the person’s turnover of the therapeutic

goods concerned for the financial year concerned is of low

value.

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Additional information

(4) The regulations may provide for the obtaining of additional

information or documents from applicants for exemptions or

persons granted exemptions.

Merits review

(5) The regulations may provide for review by the Administrative

Appeals Tribunal of decisions of the Secretary to refuse

applications for exemptions or to cancel exemptions.

No limit on subsection (1)

(6) Subsections (2) to (5) do not limit subsection (1).

Low value turnover

(7) For the purposes of this section, the regulations may specify when

a person’s turnover of therapeutic goods for a financial year is of

low value. The regulations may specify different rules for different

therapeutic goods.

Interpretation

(8) This section does not limit paragraph 63(3)(b) (about the refund,

reduction or waiving of fees or charges).

Definitions

(9) In this section:

approved person means a person included in a class of persons

specified in regulations made for the purposes of this definition.

turnover has the meaning prescribed by the regulations.

44B Recovery of unpaid charges

An amount of an annual registration charge, an annual listing

charge, an annual charge for inclusion in the Register or an annual

licensing charge that remains unpaid at the end of the period of 28

days after the day on which the charge becomes payable may be

recovered by the Commonwealth as a debt due to the

Commonwealth.

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Note: Section 44 sets out the day on which a charge becomes payable.

45 Therapeutic Goods Administration Account

(1) There is continued in existence the Therapeutic Goods

Administration Account.

Note: The Account was established by subsection 5(3) of the Financial Management Legislation Amendment Act 1999.

(2) The Account is a Special Account for the purposes of the Financial

Management and Accountability Act 1997.

(3) There must be credited to the Account amounts equal to:

(a) amounts received by the Commonwealth by way of annual

registration charge, annual listing charge, annual charge for

inclusion in the Register and annual licensing charge; and

(b) interest received by the Commonwealth from the investment

of an amount standing to the credit of the Account; and

paid for after a debit from the Account; and

(d) money received by the Commonwealth for services provided

or to be provided, by or on behalf of the Commonwealth,

using amounts standing to the credit of the Account

(including amounts received by way of fees payable under

the regulations); and

(e) donations for the furtherance of a purpose of the Account that

are received by the Commonwealth; and

(f) receipts relating to the recovery of debts (other than debts in

respect of statutory fines and penalties) by the

Commonwealth that are associated with expenditure of an

amount standing to the credit of the Account.

Note: An Appropriation Act provides for amounts to be credited to a Special Account if any of the purposes of the Account is a purpose that is covered by an item in the Appropriation Act.

(4) The purposes of the Account are to make payments:

(a) to further the objects of this Act (as set out in section 4); and

(b) to enable the Commonwealth to participate in the

international harmonisation of regulatory controls on

therapeutic goods and other related activities.

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Part 6-2—Entry, searches and warrants

45A Definitions

In this Part, unless the contrary intention appears:

evidential material means:

(a) in respect of an offence against this Act:

(i) any thing with respect to which the offence has been

committed or is suspected, on reasonable grounds, to

have been committed; or

(ii) any thing as to which there are reasonable grounds for

suspecting that it will afford evidence as to the

commission of the offence; or

(iii) any thing as to which there are reasonable grounds for

suspecting that it is intended to be used for the purpose

of committing the offence; and

(b) in respect of a contravention of a civil penalty provision:

(i) any thing with respect to which the civil penalty

provision has been contravened or is suspected, on

reasonable grounds, of having been contravened; or

(ii) any thing as to which there are reasonable grounds for

suspecting that it will afford evidence as to the

contravention of the civil penalty provision; or

(iii) any thing as to which there are reasonable grounds for

suspecting that it is intended to be used for the purpose

of contravening the civil penalty provision.

occupier, in relation to premises, includes a person present at the

premises who is in apparent control of the premises.

seize includes secure against interference.

thing includes a substance, and a thing in electronic or magnetic

form.

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46 Searches to monitor compliance with Act

(1) Subject to subsections (2) and (3), an authorised person may, for

the purpose of finding out whether this Act or the regulations have

been complied with:

(a) enter any premises; and

(b) exercise the powers set out in subsection 48(1).

(2) The authorised person must not enter the premises unless:

(a) the occupier of the premises has consented to the entry; or

(b) the entry is made under a warrant issued under section 49.

(3) An authorised person is not entitled to exercise any powers under

subsection (1) in relation to premises if:

(a) the occupier of the premises has required the authorised

person to produce his or her identity card for inspection by

the occupier; and

(b) the authorised person fails to comply with the requirement.

46A Searches of certain premises to monitor compliance with Act

(1) An authorised person may, subject to subsections (2) and (3), and

to the extent that it is reasonably necessary for the purpose of

finding out whether this Act or the regulations have been complied

with, enter premises to which this section applies and do any of the

following:

(a) search the premises and any thing on the premises;

(b) inspect, examine, take measurements of, conduct tests on or

take samples of any therapeutic goods on the premises or any

thing on the premises that relates to any therapeutic goods;

premises or any thing on the premises;

(d) inspect any book, record or document on the premises.

(2) An authorised person must not, under subsection (1), enter

premises that are a residence unless:

(a) the occupier of the premises has consented to the entry; or

(b) the premises are used for commercial purposes in relation to

therapeutic goods, in addition to residential purposes.

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(3) An authorised person is not entitled to exercise any powers under

subsection (1) in relation to premises if:

(a) the occupier of the premises has required the authorised

person to produce his or her identity card for inspection by

the occupier; and

(b) the authorised person fails to comply with the requirement.

(4) This section applies to:

(a) premises of a person:

(ia) who is required to comply with a condition of an

exemption of therapeutic goods under section 18A; or

(i) who has been granted an approval or authority under

section 19; or

(ii) who has been granted an approval under section 19A; or

(iiaaa) who is required to comply with a condition of an

exemption of biologicals under section 32CB; or

(iiaab) who has been granted an approval under

subsection 32CK(1) or an authority under

subsection 32CM(1); or

(iiaac) who has been granted an approval under

subsection 32CO(1) or (2); or

(iiaa) who is required to comply with a condition of an

exemption of a kind of medical device under

section 41GS; or

(iia) who has been granted an approval or authority under

section 41HB or 41HC; or

(iib) who has been granted an approval under

subsection 41HD(1) or (2); or

(iii) in relation to whom therapeutic goods are registered,

listed or included in the Register;

being premises connected with the importation, export,

manufacture or supply of therapeutic goods, or the keeping of

records relating to the importation, export, manufacture or

supply of therapeutic goods; and

(b) premises to which the person in relation to whom therapeutic

goods are registered, listed or included in the Register, or the

sponsor of the goods, must allow access as a condition of the

registration or listing of the therapeutic goods; and

under Part 3-3 for, or a conformity assessment certificate

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issued under Part 4-4, in relation to the manufacture of

therapeutic goods, or premises at which records are kept in

relation to such manufacture.

46B Searches and seizures on public health grounds

(1) Subject to subsection (2), if an authorised person has reasonable

grounds for suspecting that:

(a) there may be on any premises a particular thing in respect of

which this Act or the regulations have not been complied

with; and

(b) it is necessary in the interests of public health to exercise

powers under this section in order to avoid an imminent risk

of death, serious illness or serious injury;

the authorised person may, to the extent that it is reasonably

necessary for the purpose of avoiding an imminent risk of death,

serious illness or serious injury, enter the premises and do any of

the following:

(d) if the authorised person finds the thing on the premises—

seize it.

(2) An authorised person is not entitled to exercise any powers under

subsection (1) in relation to premises if:

(a) the occupier of the premises has required the authorised

person to produce his or her identity card for inspection by

the occupier; and

(b) the authorised person fails to comply with the requirement.

47 Searches and seizures related to offences and civil penalty

provisions

(1) Subject to subsections (2) and (3), if an authorised person has

reasonable grounds for suspecting that there may be evidential

material in respect of an offence against this Act, in respect of a

contravention of a civil penalty provision or in respect of both on

any premises, the authorised person may:

(a) enter the premises; and

(b) exercise the powers set out in subsection (4) and

subsection 48(1); and

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seize it.

(2) The authorised person must not enter the premises unless:

(a) the occupier of the premises has consented to the entry; or

(b) the entry is made under a warrant issued under section 50.

(3) An authorised person is not entitled to exercise any powers under

subsection (1) in relation to premises if:

(a) the occupier of the premises has required the authorised

person to produce his or her identity card for inspection by

the occupier; and

(b) the authorised person fails to comply with the requirement.

(4) If:

(a) in the course of searching, in accordance with a warrant, for a

particular thing, an authorised person finds another thing that

the authorised person believes on reasonable grounds to be

evidential material in respect of an offence against this Act,

in respect of a contravention of a civil penalty provision or in

respect of both; and

(b) the authorised person believes, on reasonable grounds, that it

is necessary to seize that other thing in order to prevent its

concealment, loss or destruction, or its use:

(i) in committing, continuing or repeating an offence

against this Act; or

(ii) in committing, continuing or repeating a contravention

of a civil penalty provision;

the warrant is taken to authorise the authorised person to seize that

other thing.

48 General powers of authorised persons in relation to premises

(1) The powers an authorised person may exercise under paragraphs

46(1)(b) and 47(1)(b) are as follows:

(a) to search the premises and any thing on the premises;

(b) to inspect, examine, take measurements of, conduct tests on

or take samples of any therapeutic goods on the premises or

any thing on the premises that relates to any therapeutic

goods;

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premises or any thing on the premises;

(d) if the authorised person was only authorised to enter the

premises because the occupier of the premises consented to

the entry—to require the occupier to:

(i) answer any questions put by the authorised person; and

(ii) produce any book, record or document requested by the

authorised person;

(e) if the authorised person was authorised to enter the premises

by a warrant under section 49 or 50—to require any person in

or on the premises to:

(i) answer any questions put by the authorised person; and

(ii) produce any book, record or document requested by the

authorised person;

(f) to inspect any book, record or document on the premises;

(g) to take extracts from or make copies of any such book, record

or document;

(h) to take onto the premises such equipment and materials as the

authorised person requires for the purpose of exercising

powers in relation to the premises.

(3) A person must not refuse or fail to comply with a requirement

under paragraph (1)(e).

Penalty: 30 penalty units.

(3A) Subsection (3) does not apply if the person has a reasonable

excuse.

Note: The defendant bears an evidential burden in relation to the matter in subsection (3A). See subsection 13.3(3) of the Criminal Code.

(4) It is a reasonable excuse for a person to refuse or fail to answer a

question or produce a document if answering the question, or

producing the document, would tend to incriminate the person.

48A Details of warrant to be given to occupier etc.

(1) If a warrant in relation to premises is being executed and the

occupier of the premises or another person who apparently

represents the occupier is present at the premises, the authorised

person must make available to that person a copy of the warrant.

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(2) The authorised person must identify himself or herself to that

person.

(3) The copy of the warrant referred to in subsection (1) need not

include the signature of the magistrate who issued the warrant.

48B Announcement before entry

(1) An authorised person must, before entering the premises under a

warrant:

(a) announce that he or she is authorised to enter the premises;

and

(b) give any person at the premises an opportunity to allow entry

to the premises.

(2) An authorised person is not required to comply with subsection (1)

if he or she believes on reasonable grounds that immediate entry to

the premises is required to ensure:

(a) the safety of a person; or

(b) that the effective execution of the warrant is not frustrated.

48C Use of electronic equipment at premises

(1) The authorised person may operate electronic equipment at the

premises to see whether evidential material in respect of an offence

against this Act, in respect of a contravention of a civil penalty

provision or in respect of both is accessible by doing so if he or she

believes on reasonable grounds that the operation of the equipment

can be carried out without damage to the equipment.

(2) If the authorised person, after operating the equipment, finds that

evidential material in respect of an offence against this Act, in

respect of a contravention of a civil penalty provision or in respect

of both is accessible by doing so, he or she may:

(a) seize the equipment and any disk, tape or other associated

device; or

(b) if the material can, by using facilities at the premises, be put

in documentary form—operate the facilities to put the

material in that form and seize the documents so produced; or

storage device that:

(i) is brought to the premises; or

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(ii) is at the premises and the use of which for the purpose

has been agreed to in writing by the occupier of the

premises;

operate the equipment or other facilities to copy the material to the

storage device and take the storage device from the premises.

(3) An authorised person may seize equipment under paragraph (2)(a)

only if:

(a) it is not practicable to put the material in documentary form

as mentioned in paragraph (2)(b) or to copy the material as

mentioned in paragraph (2)(c); or

(b) possession by the occupier of the equipment could constitute

an offence.

(4) If the authorised person believes on reasonable grounds that:

(a) evidential material in respect of an offence against this Act,

in respect of a contravention of a civil penalty provision or in

respect of both may be accessible by operating electronic

equipment at the premises; and

(b) expert assistance is required to operate the equipment; and

material may be destroyed, altered or otherwise interfered

with;

he or she may do whatever is necessary to secure the equipment,

whether by locking it up, placing a guard or otherwise.

(5) The authorised person must give notice to the occupier of the

premises of his or her intention to secure equipment and of the fact

that the equipment may be secured for up to 24 hours.

(6) The equipment may be secured:

(a) for a period not exceeding 24 hours; or

(b) until the equipment has been operated by the expert;

whichever happens first.

(7) If the authorised person believes on reasonable grounds that the

expert assistance will not be available within 24 hours, he or she

may apply to the magistrate for an extension of that period.

(8) The authorised person must give notice to the occupier of the

premises of his or her intention to apply for an extension, and the

occupier is entitled to be heard in relation to the application.

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48D Compensation for damage to electronic equipment

(1) If:

(a) damage is caused to equipment as a result of it being

operated as mentioned in section 48C; and

(b) the damage was caused as a result of:

(i) insufficient care being exercised in selecting the person

who was to operate the equipment; or

(ii) insufficient care being exercised by the person operating

the equipment;

compensation for the damage is payable to the owner of the

equipment.

(2) Compensation is payable out of money appropriated by the

Parliament for the purpose.

(3) In determining the amount of compensation payable, regard is to

be had to whether the occupier of the premises and his or her

employees and agents, if they were available at the time, had

provided any warning or guidance as to the operation of the

equipment that was appropriate in the circumstances.

48E Copies of seized things to be provided

(1) Subject to subsection (2), if an authorised person seizes, under a

warrant relating to premises:

(a) a document, film, computer file or other thing that can be

readily copied; or

(b) a storage device the information in which can be readily

copied;

the authorised person must, if requested to do so by the occupier of

the premises or another person who apparently represents the

occupier and who is present when the warrant is executed, give a

copy of the thing or the information to that person as soon as

practicable after the seizure.

(2) Subsection (1) does not apply if:

(a) the thing that has been seized was seized under

paragraph 48C(2)(b) or (c); or

(b) possession by the occupier of the document, film, computer

file, thing or information could constitute an offence or the

contravention of a civil penalty provision.

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48F Occupier entitled to be present during search

(1) If a warrant in relation to premises is being executed and the

occupier of the premises or another person who apparently

represents the occupier is present at the premises, the person is

entitled to observe the search being conducted.

(2) The right to observe the search being conducted ceases if the

person impedes the search.

(3) This section does not prevent 2 or more areas of the premises being

searched at the same time.

48G Receipts for things seized under warrant

(1) If a thing is seized under this Part, the authorised person must

provide a receipt for the thing.

(2) If 2 or more things are seized or moved, they may be covered in

the one receipt.

48H Retention of seized things

(1) Subject to any contrary order of a court, if an authorised person

seizes a thing under this Part, an authorised person must return it if:

(a) the reason for its seizure no longer exists or it is decided that

it is not to be used in evidence; or

(b) the period of 90 days after its seizure ends;

whichever first occurs, unless the thing is forfeited or forfeitable to

the Commonwealth.

(2) At the end of the 90 days specified in subsection (1), an authorised

person must take reasonable steps to return the thing to the person

from whom it was seized, unless:

(a) proceedings in respect of which the thing may afford

evidence were instituted before the end of the 90 days and

have not been completed (including an appeal to a court in

relation to those proceedings); or

(b) an authorised person may retain the thing because of an order

under section 48J; or

order of a court, of the Commonwealth or of a State or

Territory) to retain, destroy or dispose of the thing.

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(3) The thing may be returned under subsection (2) either

unconditionally or on such terms and conditions as the Secretary

sees fit.

48J Magistrate may permit a thing to be retained

(1) An authorised person may apply to a magistrate for an order that he

or she may retain the thing for a further period if:

(a) before the end of 90 days after the seizure; or

(b) before the end of a period previously specified in an order of

a magistrate under this section;

proceedings in respect of which the thing may afford evidence

have not commenced.

(2) If the magistrate is satisfied that it is necessary for an authorised

person to continue to retain the thing:

(a) for the purposes of an investigation as to whether an offence

against this Act has been committed; or

(b) to enable evidence of an offence against this Act to be

secured for the purposes of a prosecution; or

penalty provision has been contravened; or

(d) to enable evidence of a contravention of a civil penalty

provision to be secured for the purposes of civil proceedings;

the magistrate may order that an authorised person may retain the

thing for a period (not being a period exceeding 3 years) specified

in the order.

(3) Before making the application, the authorised person must:

(a) take reasonable steps to discover who has an interest in the

retention of the thing; and

(b) if it is practicable to do so, notify each person whom the

authorised person believes to have such an interest of the

proposed application.

49 Monitoring warrants

(1) An authorised person may apply to a magistrate for a warrant

under this section in relation to premises.

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(2) Subject to subsection (3), the magistrate may issue the warrant if

the magistrate is satisfied, by information on oath, that it is

reasonably necessary that one or more authorised persons should

have access to the premises for the purposes of finding out whether

this Act or the regulations have been complied with.

(3) The magistrate must not issue the warrant unless the authorised

person or some other person has given to the magistrate, either

orally or by affidavit, such further information (if any) as the

magistrate requires concerning the grounds on which the issue of

the warrant is being sought.

(4) The warrant must:

(a) authorise one or more authorised persons (whether or not

named in the warrant), with such assistance and by such

force as is necessary and reasonable:

(i) to enter the premises; and

(ii) to exercise the powers set out in subsection 48(1) in

relation to the premises; and

(b) state whether the entry is authorised to be made at any time

of the day or night or during specified hours of the day or

night; and

warrant) on which the warrant ceases to have effect; and

(d) state the purpose for which the warrant is issued.

50 Offence and civil penalty provision related warrants

(1) An authorised person may apply to a magistrate for a warrant

under this section in relation to premises.

(2) Subject to subsection (3), the magistrate may issue the warrant if

the magistrate is satisfied, by information on oath, that there are

reasonable grounds for suspecting that there is, or there may be

within the next 72 hours, in or on the premises evidential material

in respect of an offence against this Act, in respect of a

contravention of a civil penalty provision or in respect of both.

(3) The magistrate must not issue the warrant unless the authorised

person or some other person has given to the magistrate, either

orally or by affidavit, such further information (if any) as the

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magistrate requires concerning the grounds on which the issue of

the warrant is being sought.

(4) The warrant must:

(a) name one or more authorised persons; and

(b) authorise the persons so named, with such assistance and by

such force as is necessary and reasonable:

(i) to enter the premises; and

(ii) to exercise the powers set out in subsections 47(4) and

48(1); and

(iii) to seize the evidential material; and

of the day or night or during specified hours of the day or

night; and

(d) specify the day (not more than one week after the issue of the

warrant) on which the warrant ceases to have effect; and

(e) state the purpose for which the warrant is issued.

51 Offence and civil penalty provision related warrants by telephone

(1) If, in an urgent case, an authorised person considers it necessary to

do so, the person may apply to a magistrate by telephone for a

warrant under section 50 in relation to premises.

(2) Before applying for the warrant, the person must prepare an

information of the kind mentioned in subsection 50(2) in relation to

the premises that sets out the grounds on which the warrant is

sought.

(3) If it is necessary to do so, the person may apply for the warrant

before the information is sworn.

(4) If the magistrate is satisfied:

(a) after having considered the terms of the information; and

(b) after having received such further information (if any) as the

magistrate requires concerning the grounds on which the

issue of the warrant is being sought;

that there are reasonable grounds for issuing the warrant, the

magistrate may complete and sign the same warrant that the

magistrate would issue under section 50 if the application had been

made under that section.

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(5) If the magistrate completes and signs the warrant:

(a) the magistrate must:

(i) tell the authorised person what the terms of the warrant

are; and

(ii) tell the authorised person the day on which and the time

at which the warrant was signed; and

(iii) tell the authorised person the day (not more than one

week after the magistrate completes and signs the

warrant) on which the warrant ceases to have effect; and

(iv) record on the warrant the reasons for granting the

warrant; and

(b) the authorised person must:

(i) complete a form of warrant in the same terms as the

warrant completed and signed by the magistrate; and

(ii) write on the form the name of the magistrate and the

day on which and the time at which the warrant was

signed.

(6) The authorised person must also, not later than the day after the

day of expiry or execution of the warrant, whichever is the earlier,

send to the magistrate:

(a) the form of warrant completed by the person; and

(b) the information referred to in subsection (2), which must

have been duly sworn.

(7) When the magistrate receives those documents, the magistrate

must:

(a) attach them to the warrant that the magistrate completed and

signed; and

(b) deal with them in the way in which the magistrate would

have dealt with the information if the application had been

made under section 50.

(8) A form of warrant duly completed under subsection (5) is authority

for any entry, search, seizure or other exercise of a power that the

warrant signed by the magistrate authorises.

(9) If:

(a) it is material, in any proceedings, for a court to be satisfied

that an exercise of a power was authorised by this section;

and

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(b) the warrant signed by the magistrate authorising the exercise

of the power is not produced in evidence;

the court must assume, unless the contrary is proved, that the

exercise of the power was not authorised by such a warrant.

(10) A reference in this Part to a warrant under section 50 includes a

reference to a warrant signed by a magistrate under this section.

51A Searches at request of manufacturer

(1) A person may request the Secretary to arrange for an authorised

person to inspect premises, and specified processes being carried

out on those premises, for the purposes of paragraph 2 of Article 3

of the Mutual Recognition Convention.

(2) An authorised person may make an inspection in accordance with

arrangements under subsection (1).

51B Offences relating to warrants

(1) A person must not make, in an application for a warrant, a

statement that the person knows to be false or misleading in a

material particular.

Penalty: Imprisonment for 2 years.

(2) A person must not:

(a) state in a document that purports to be a form of warrant

under section 51 the name of a magistrate unless that

magistrate issued the warrant; or

(b) state on a form of warrant under that section a matter that, to

the person’s knowledge, departs in a material particular from

the form authorised by the magistrate; or

that purports to be a form of warrant under that section that

the first-mentioned person knows:

(i) has not been approved by a magistrate under that

section; or

(ii) to depart in a material particular from the terms

authorised by a magistrate under that section; or

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(d) give to a magistrate a form of warrant under that section that

is not the form of warrant that the person purported to

execute.

Penalty: Imprisonment for 2 years.

52 Identity cards

(1) The Secretary is to ensure that each authorised person is issued

with an identity card that incorporates a recent photograph of the

person.

(3) Where a person ceases to be an authorised person, the person must,

as soon as practicable after so ceasing, return the person’s identity

card to the Secretary.

Penalty: 1 penalty unit.

(4) An offence under subsection (3) is an offence of strict liability.

Note: For strict liability, see section 6.1 of the Criminal Code.

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Part 6-3—Scheduling of substances

52AA Overview

This Part provides the basis for a uniform system in Australia of

access controls for goods containing scheduled substances.

The scheduling of substances allows restrictions to be placed on

their supply to the public, in the interests of public health and

safety. This is aimed at minimising the risks of poisoning from,

and the misuse and abuse of, scheduled substances.

52A Definitions

(1) In this Part, unless the contrary intention appears:

current Poisons Standard means:

(a) if no document has been prepared under

paragraph 52D(2)(b)—the first Poisons Standard; or

(b) otherwise—the document last prepared under that

paragraph (including as amended).

first Poisons Standard means the latest edition at the

commencement of this Part of the document known as the

Standard for the Uniform Scheduling of Drugs and Poisons

published by the Australian Health Ministers’ Advisory Council.

scheduling, in relation to a substance, means determining the

schedule or schedules to the current Poisons Standard in which the

name or a description of the substance is to be included.

substance means:

(a) an ingredient, compound, material or preparation which, or

the use of which, may cause death, illness or injury to

persons or animals; or

(b) an ingredient, compound, material or preparation specified

under subsection (2);

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and includes any ingredient, compound, material or preparation

referred to in a schedule to the current Poisons Standard (as in

force immediately before 1 July 2010).

(2) The Secretary may, by legislative instrument, specify an

ingredient, compound, material or preparation for the purposes of

paragraph (b) of the definition of substance in subsection (1).

Note: For specification by class, see subsection 13(3) of the Legislative Instruments Act 2003.

52B Advisory Committee on Medicines Scheduling

(1) The Advisory Committee on Medicines Scheduling is established

by this section.

(2) Subject to subsection (3), the Committee is to be constituted, and

to hold meetings, in accordance with the regulations.

(3) The Commonwealth, each State, the Australian Capital Territory

and the Northern Territory are each entitled to nominate a member

of the Committee in accordance with the regulations.

(4) The functions of the Committee are as follows:

(a) subject to subsection (5), to make recommendations to the

Secretary in relation to the classification and scheduling of

substances that are, or are included in, therapeutic goods;

(b) to make recommendations to the Secretary in relation to

other changes to the current Poisons Standard (other than the

schedules);

(b) at the request of the Secretary;

(d) subject to subsection (5), to provide advice to the Secretary

in relation to the restrictions (including restrictions as to

accessibility and availability) to be imposed in respect of

particular substances that are, or are included in, therapeutic

goods;

(e) to provide advice to the Secretary in relation to any matter

referred to it by the Secretary;

(f) any other functions that are prescribed by the regulations.

(5) Paragraphs (4)(a) and (d) do not apply in relation to substances to

the extent that the substances are included in goods other than

therapeutic goods.

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52C Advisory Committee on Chemicals Scheduling

(1) The Advisory Committee on Chemicals Scheduling is established

by this section.

(2) Subject to subsection (3), the Committee is to be constituted, and

to hold meetings, in accordance with the regulations.

(3) The Commonwealth, each State, the Australian Capital Territory

and the Northern Territory are each entitled to nominate a member

of the Committee in accordance with the regulations.

(4) The functions of the Committee are as follows:

(a) subject to subsection (5), to make recommendations to the

Secretary in relation to the classification and scheduling of

substances;

(b) to make recommendations to the Secretary in relation to

other changes to the current Poisons Standard (other than the

schedules);

(b) at the request of the Secretary;

(d) subject to subsection (5), to provide advice to the Secretary

in relation to the restrictions (including restrictions as to

accessibility and availability) to be imposed in respect of

particular substances;

(e) to provide advice to the Secretary in relation to any matter

referred to it by the Secretary;

(f) any other functions that are prescribed by the regulations.

(5) Paragraphs (4)(a) and (d) do not apply in relation to substances to

the extent that the substances are, or are included in, therapeutic

goods.

52CA Joint meetings

The Advisory Committee on Medicines Scheduling and the

Advisory Committee on Chemicals Scheduling may hold joint

meetings in accordance with the regulations.

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52D Poisons Standard

(1) On the commencement of this Part, the first Poisons Standard is

taken to have been prepared and made available by the then

National Drugs and Poisons Schedule Committee.

(2) Subject to this Act and the regulations, the Secretary may:

(a) amend the current Poisons Standard; or

(b) prepare a document (including schedules containing the

names or descriptions of substances or classes of substances),

in substitution for the current Poisons Standard.

(3) The Secretary may exercise a power under subsection (2) on the

Secretary’s own initiative or following an application under

section 52EAA.

(4A) An instrument made under paragraph (2)(a) or (b) after the

commencement of this subsection is a legislative instrument, but

section 42 (disallowance) of the Legislative Instruments Act 2003

does not apply to the instrument.

(4B) Despite subsection 14(2) of the Legislative Instruments Act 2003,

an instrument made under paragraph (2)(a) or (b) of this section

may make provision in relation to a matter by applying, adopting

or incorporating any matter contained in an instrument or other

writing as in force or existing from time to time.

(5) In this section:

amend, in relation to the current Poisons Standard, means:

(a) alter any provision (including a reference to a substance) in

the current Poisons Standard; or

(b) omit any provision (including a reference to a substance)

from the current Poisons Standard; or

the current Poisons Standard.

52E Secretary to take certain matters into account in exercising

powers

(1) In exercising a power under subsection 52D(2), the Secretary must

take the following matters into account (where relevant):

(a) the risks and benefits of the use of a substance;

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(b) the purposes for which a substance is to be used and the

extent of use of a substance;

(d) the dosage, formulation, labelling, packaging and

presentation of a substance;

(e) the potential for abuse of a substance;

(f) any other matters that the Secretary considers necessary to

protect public health.

(2) In exercising a power under subsection 52D(2), the Secretary must

comply with any guidelines of:

(a) the Australian Health Ministers’ Advisory Council; and

(b) the subcommittee of the Council known as the National

Coordinating Committee on Therapeutic Goods (or any

replacement subcommittee);

notified to the Secretary for the purposes of this section.

(3) In exercising a power under subsection 52D(2), the Secretary must

have regard to any recommendations or advice of the Advisory

Committee on Medicines Scheduling or the Advisory Committee

on Chemicals Scheduling.

(4) In exercising a power under subsection 52D(2), the Secretary may

seek advice from either or both of the following:

(a) any committee that the Secretary considers appropriate

(whether or not the committee is established under this Act or

the regulations);

(b) any person.

(5) Subsections (2) to (4) do not limit the information the Secretary

may consider in exercising a power under subsection 52D(2).

52EAA Application for amendment of the Poisons Standard

(1) A person may apply to the Secretary for an amendment of the

current Poisons Standard.

(2) An application under subsection (1) must:

(a) be made in accordance with a form approved by the

Secretary; and

(b) set out the amendment sought; and

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form; and

(d) be accompanied by the prescribed application fee.

Further information

(3) The Secretary may, by notice in writing given to the person,

require the person to give to the Secretary, within such reasonable

time as is specified in the notice, such further information

concerning the application as is specified in the notice.

Applications or information may be given electronically

(4) An approval of a form mentioned in paragraph (2)(a), or a notice

mentioned in subsection (3), may require or permit an application

or information to be given in accordance with specified software

requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.

52EA Poisons Standard—validation etc.

Scope

(1) This section applies to the following instruments:

(a) the first Poisons Standard;

(b) an instrument made under paragraph 52D(2)(a) or (b) before

the commencement of this section;

whether or not the instrument is in force as at the commencement

of this section.

Disallowance

(2) Section 42 (disallowance) of the Legislative Instruments Act 2003

does not apply, and is taken never to have applied, to the

instrument.

Deemed registration etc.

(3) If:

(a) the instrument was required to be registered under Division 2

of Part 4 of the Legislative Instruments Act 2003; and

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(b) the instrument was not registered;

that Act has effect, and is taken always to have had effect, as if:

after the instrument was made; and

(d) the instrument had been registered immediately after it was

lodged for registration; and

(e) any other requirement imposed by that Act in relation to the

instrument had been met.

(4) If:

(a) the instrument was required to be registered under Division 3

of Part 4 of the Legislative Instruments Act 2003; and

(b) the instrument was not lodged for registration on or before

the last day for lodging the instrument for registration (the

last lodgment day) worked out under section 29 of that Act;

that Act has effect, and is taken always to have had effect, as if:

lodgment day; and

(d) the instrument had been registered immediately after it was

lodged for registration; and

(e) any other requirement imposed by that Act in relation to the

instrument had been met.

Definition

(5) In this section:

register has the same meaning as in the Legislative Instruments Act

2003.

52EB Compensation for acquisition of property

(1) If the operation of section 52EA would result in an acquisition of

property from a person otherwise than on just terms, the

Commonwealth is liable to pay a reasonable amount of

compensation to the person.

(2) If the Commonwealth and the person do not agree on the amount

of the compensation, the person may institute proceedings in the

Federal Court for the recovery from the Commonwealth of such

reasonable amount of compensation as the court determines.

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(3) In this section:

acquisition of property has the same meaning as in

paragraph 51(xxxi) of the Constitution.

just terms has the same meaning as in paragraph 51(xxxi) of the

Constitution.

52EC Review of scheduling regime

(1) The Minister must cause an independent review of the operation of

this Part to be conducted, with particular reference to the

amendments to this Part made by the Therapeutic Goods

Amendment (2009 Measures No. 2) Act 2009 (the amendments).

(2) The review must:

(a) start not later than 1 July 2013; and

(b) be completed within 6 months.

(3) The review must report on:

(a) the system of access controls for goods containing scheduled

substances established by this Part;

(b) the outcomes of the administration of scheduled substances

by the Secretary and by the committees established by this

Part;

industry and on individual parties within the industry;

(d) whether there are adequate avenues for review of decisions

made by the Secretary and by the committees established by

this Part;

and may make recommendations for further changes to the

scheduling regime.

(4) The review must be conducted by a panel which must comprise not

less than three, and not more than five, persons with relevant

expertise.

(5) As part of the review, the panel must invite and consider public

submissions.

(6) The panel must give the Minister a written report of the review.

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(7) The Minister must cause a copy of the report to be laid before each

House of the Parliament within 15 sitting days of that House after

the day on which the Minister receives the report.

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Chapter 7—Miscellaneous

53 Retention of material on withdrawal of application

Where a person withdraws an application for:

(a) registration; or

(b) listing; or

(ba) inclusion of a biological in the Register; or

(d) inclusion of a kind of medical device in the Register; or

(e) a licence;

the Department may retain the application and any material

submitted in connection with the application.

53A Alternative verdicts for various offences

If a jury acquits a person of an offence against a provision listed in

column 2 of an item in the following table, but is satisfied beyond

reasonable doubt of facts that prove that the person is guilty of the

offence listed in column 3 of that item, the jury may convict the

person of the offence listed in column 3 of that item:

Alternative verdicts for various offences

Column 1 Column 2 Column 3

Item If a prosecution is for

an offence against...

the jury may instead

convict the person of an

offence against...

1 subsection 14(1) subsection 14(4)

2 subsection 14(6) subsection 14(9)

3 subsection 14(10) subsection 14(13)

4 subsection 15(2) subsection 15(5)

5 subsection 19B(1) subsection 19B(4)

6 subsection 21A(1) subsection 21A(4)

7 subsection 21A(5) subsection 21A(8)

8 subsection 21A(9) subsection 22(7A)

9 subsection 21A(12) subsection 22(8)

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Alternative verdicts for various offences

Column 1 Column 2 Column 3

Item If a prosecution is for

an offence against...

the jury may instead

convict the person of an

offence against...

10 subsection 22A(1) subsection 22A(4)

11 subsection 30EC(1) subsection 30EC(4)

12 subsection 30F(4B) subsection 30F(5)

13 subsection 31(5A) subsection 31(6)

13A subsection 32BA(1) subsection 32BA(4)

13B subsection 32BB(1) subsection 32BB(4)

13C subsection 32BC(1) subsection 32BC(4)

13D subsection 32BD(1) subsection 32BD(4)

13E subsection 32BI(1) subsection 32BI(4)

13F subsection 32CN(1) subsection 32CN(4)

13G subsection 32DO(1) subsection 32DO(4)

13H subsection 32EF(1) subsection 32EF(4)

13J subsection 32HC(1) subsection 32HC(4)

13K subsection 32JB(2) subsection 32JB(5)

14 subsection 35(1) subsection 35(4)

15 subsection 35(5) subsection 35(9)

16 subsection 35B(1) subsection 35B(4)

17 subsection 41EI(1) subsection 41EI(4)

18 subsection 41FE(1) subsection 41FE(4)

19 subsection 41JB(4) subsection 41JB(7)

20 subsection 41KC(1) subsection 41KC(4)

21 subsection 41MA(1) subsection 41MA(4)

22 subsection 41MA(5) subsection 41MA(8)

23 subsection 41MA(9) subsection 41MA(12)

24 subsection 41MC(2) subsection 41MC(5)

25 subsection 41ME(1) subsection 41ME(4)

26 subsection 41ME(5) subsection 41ME(8)

27 subsection 41MF(1) subsection 41MF(2)

28 subsection 41MF(3) subsection 41MF(4)

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Alternative verdicts for various offences

Column 1 Column 2 Column 3

Item If a prosecution is for

an offence against...

the jury may instead

convict the person of an

offence against...

29 subsection 41MI(1) subsection 41MI(4)

30 subsection 41MN(1) subsection 41MN(4)

31 subsection 41MN(5) subsection 41MN(8)

32 subsection 41MO(1) subsection 41MO(4)

33 subsection 41MO(5) subsection 41MO(8)

34 subsection 42V(6) subsection 42V(6C)

54 Offences and forfeiture

(3) If a court:

(a) convicts a person of an offence against this Act; or

(b) orders a person to pay a pecuniary penalty for the

contravention of a civil penalty provision;

in relation to any therapeutic goods, the court may order that the

goods be forfeited to the Commonwealth and, if an order is made,

the goods become the property of the Commonwealth.

(4) Where goods are so forfeited, the Secretary may cause notice of the

forfeiture to be published in the Gazette.

(5) Goods forfeited under an order referred to in subsection (3) are to

be disposed of in such manner as the Secretary directs.

54AA Offences for contravening conditions or requirements

imposed under the regulations

(1) If:

(a) a person holds a licence or a permission to import or export

therapeutic goods; and

(b) the person engages in conduct; and

the licence or permission is subject under the regulations;

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the person is guilty of an offence punishable on conviction by a

fine of no more than the number of penalty units specified in

whichever of subsection (2) or (3) applies.

(1A) In subsection (1):

engage in conduct means:

(a) do an act; or

(b) omit to perform an act.

(2) If:

(a) the condition or requirement relates to the possession,

custody, transport, use or disposal of the goods; or

(b) the regulation providing for the condition or requirement

states that the purpose of the condition or requirement is to

protect the safety of the public;

the number of penalty units for the contravention is 240 penalty

units.

(3) If subsection (2) does not apply, the number of penalty units for the

contravention is 50 penalty units.

54AB Criminal offence for damaging etc. documents

(1) A person is guilty of an offence if:

(a) the person damages, destroys, alters, conceals or falsifies a

document; and

(b) the document is created, retained or issued for the purposes

of this Act, or for purposes that include the purposes of this

Act.

Penalty: 7 years imprisonment or 2,000 penalty units, or both.

Note: For the liability of an executive officer of a body corporate, see sections 54B and 54BA.

(2) Strict liability applies to paragraph (1)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

54AC Civil penalty for damaging etc. documents

A person contravenes this section if:

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(a) the person damages, destroys, alters, conceals or falsifies a

document; and

(b) the document is created, retained or issued for the purposes

of this Act, or for purposes that include the purposes of this

Act; and

falsification is likely to interfere with the proper

administration of this Act or the regulations.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

(b) for a body corporate—50,000 penalty units.

54A Time for bringing prosecutions

A prosecution for an offence against this Act may be commenced

at any time within 3 years after the commission of the offence.

54B Personal liability of an executive officer of a body corporate—

general

(1) An executive officer of a body corporate commits an offence if:

(a) the body corporate commits an offence against this Act

covered by section 54BA; and

(b) the officer knew that the offence would be committed; and

body in relation to the commission of the offence; and

(d) the officer failed to take all reasonable steps to prevent the

commission of the offence.

Note: An offence against this Act includes an offence against the regulations: see subsection 3(7).

(2) The maximum penalty for an offence against subsection (1) is the

maximum penalty that a Court could impose in respect of an

individual for the offence committed by the body corporate.

(3) An executive officer of a body corporate contravenes this

subsection if:

(a) the body corporate contravenes a civil penalty provision; and

(b) the officer knew that the contravention would occur; and

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body in relation to the contravention; and

(d) the officer failed to take all reasonable steps to prevent the

contravention.

(4) The maximum civil penalty for a contravention of subsection (3) is

the maximum civil penalty that a Court could impose in respect of

an individual for the civil penalty provision contravened by the

body corporate.

(5) In this section:

executive officer of a body corporate means a person, by whatever

name called and whether or not a director of the body, who is

concerned in, or takes part in, the management of the body.

54BA Personal liability of an executive officer of a body corporate—

offences covered

For the purposes of paragraph 54B(1)(a), this section covers

offences against:

(a) the provisions of this Act listed in the following table; and

(b) a provision of a regulation prescribed for the purpose of this

paragraph; and

11.5 of the Criminal Code, in relation to an offence

mentioned in paragraph (a) or (b) of this subsection; and

(d) section 136.1, 137.1 or 137.2 of the Criminal Code in

relation to this Act or a regulation.

Corporate offences for which executive officers may be personally liable

Item Provisions of this Act

1 Subsection 14(1), (2), (6), (7), (10) or (11)

2 Subsection 15(2) or (3)

3 Subsection 19B(1) or (2)

4 Subsection 21A(1), (2), (5) or (6)

5 Subsection 22(7AB)

6 Subsection 22A(1) or (2)

7 Subsection 29A(1)

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Corporate offences for which executive officers may be personally liable

Item Provisions of this Act

8 Subsection 29B(3) or (4)

9 Subsection 30EC(1) or (2)

10 Subsection 30F(4B) or (4C)

11 Subsection 31(5A) or (5B)

12 Subsection 31D(1)

13 Subsection 31E(1)

14 Subsection 32BA(1) or (2)

15 Subsection 32BB(1) or (2)

16 Subsection 32BC(1) or (2)

17 Subsection 32BD(1) or (2)

18 Subsection 32CH(1)

19 Subsection 32CJ(6) or (7)

20 Subsection 32DO(1) or (2)

21 Subsection 32DQ(1)

22 Subsection 32DR(3) or (4)

23 Subsection 32EF(1) or (2)

24 Subsection 32HC(1) or (2)

25 Subsection 32JB(2) or (3)

26 Subsection 32JI(2)

27 Subsection 35(1), (2), (5) or (7)

28 Subsection 41EI(1) or (2)

29 Subsection 41FE(1) or (2)

30 Subsection 41JB(4) or (5)

31 Section 41JH

32 Subsection 41JI(1)

33 Subsection 41KC(1) or (2)

34 Subsection 41MA(1), (2), (5), (6), (9) or (10)

35 Subsection 41MC(2) or (3)

36 Subsection 41ME(1), (2), (5) or (6)

37 Subsection 41MF(1) or (3)

38 Section 41MH

39 Subsection 41MI(1) or (2)

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Corporate offences for which executive officers may be personally liable

Item Provisions of this Act

40 Subsection 41MN(1) or (2)

41 Subsection 41MNB(1)

42 Subsection 41MP(1)

43 Subsection 41MQ(3) or (4)

44 Subsection 42E(1)

45 Subsection 42T(1) or (2)

46 Subsection 42V(6) or (6A)

47 Subsection 42W(1) or (2)

48 Subsection 54AB(1)

54C Establishing whether an executive officer took reasonable steps

to prevent the commission of an offence or the

contravention of a civil penalty provision

(1) For the purposes of section 54B, in determining whether an

executive officer of a body corporate failed to take all reasonable

steps to prevent the commission of the offence or the contravention

of a civil penalty provision, a court is to have regard to:

(a) what action (if any) the officer took towards ensuring that the

body’s employees, agents and contractors have a reasonable

knowledge and understanding of the requirements to comply

with this Act and the regulations, in so far as those

requirements affect the employees, agents or contractors

concerned; and

(b) what action (if any) the officer took when he or she became

aware that the body was committing an offence against, or

otherwise contravening, this Act or the regulations.

(2) This section does not, by implication, limit the generality of

section 54B.

(3) In this section, executive officer has the same meaning as in

section 54B.

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55 Conduct by directors, servants and agents

(1) Where, in proceedings for an offence against this Act, or for a

contravention of a civil penalty provision, it is necessary to

establish the state of mind of a body corporate in relation to

particular conduct, it is sufficient to show:

(a) that the conduct was engaged in by a director, servant or

agent of the body corporate within the scope of his or her

actual or apparent authority; and

(b) that the director, servant or agent had the state of mind.

(2) Any conduct engaged in on behalf of a body corporate by a

director, servant or agent of the body corporate within the scope of

his or her actual or apparent authority is to be taken, for the

purposes of a prosecution for an offence against this Act, or for a

contravention of a civil penalty provision, to have been engaged in

also by the body corporate unless the body corporate establishes

that the body corporate took reasonable precautions and exercised

due diligence to avoid the conduct.

(3) Where, in proceedings for an offence against this Act, or for a

contravention of a civil penalty provision, it is necessary to

establish the state of mind of a person other than a body corporate

in relation to particular conduct, it is sufficient to show that:

(a) the conduct was engaged in by a servant or agent of the

person within the scope of his or her actual or apparent

authority; and

(b) the servant or agent had the state of mind.

(4) Any conduct engaged in on behalf of a person other than a body

corporate (in this subsection called the employer) by a servant or

agent of the employer within the scope of his or her actual or

apparent authority is to be taken, for the purposes of a prosecution

for an offence against this Act, or for a contravention of a civil

penalty provision, to have been engaged in also by the employer

unless the employer establishes that he or she took reasonable

precautions and exercised due diligence to avoid the conduct.

(5) Where:

(a) a person other than a body corporate is convicted of an

offence; and

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(b) the person would not have been convicted of the offence if

subsections (3) and (4) had not been enacted;

the person is not liable to be punished by imprisonment for that

offence.

(6) A reference in subsection (1) or (3) to the state of mind of a person

includes a reference to:

(a) the knowledge, intention, opinion, belief or purpose of the

person; and

(b) the person’s reasons for the intention, opinion, belief or

purpose.

(7) A reference in this section to a director of a body corporate

includes a reference to a constituent member of a body corporate

incorporated for a public purpose by a law of the Commonwealth,

of a State or of a Territory.

(8) A reference in this section to engaging in conduct includes a

reference to failing or refusing to engage in conduct.

56 Judicial notice

All courts (except in proceedings under Chapter 4) are to take

judicial notice of the British Pharmacopoeia, the European

Pharmacopoeia, the United States Pharmacopeia-National

Formulary, a homoeopathic pharmacopoeia and an anthroposophic

pharmacopoeia.

56A Certificates to provide evidence of certain matters

(1) The Secretary or a person authorised in writing by him or her to

give certificates under this section may certify in writing that, at a

specified time, or at all times during a specified period:

(a) there was no exemption in effect under section 18 or 18A in

relation to particular therapeutic goods; or

(aaaa) a person was not exempt under subsection 32CA(1) in

relation to a particular biological or there was no exemption

under subsection 32CA(2) in relation to a particular

biological; or

(aaab) there was no exemption in effect under section 32CB in

relation to a particular biological; or

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(aaa) there was no exemption in force under section 41GS in

relation to a particular kind of medical device; or

(aa) particular medical devices were not exempt devices;

(b) there was no approval or authority under section 19 granted

to a particular person in relation to particular therapeutic

goods; or

(baa) there was no approval under subsection 32CK(1) or authority

under subsection 32CM(1) granted to a particular person in

relation to a particular biological; or

(ba) there was no approval or authority in effect under

section 41HB or 41HC granted to a particular person in

relation to particular medical devices;

(bb) there was no approval under subsection 41HD(1) or (2)

granted to a particular person in relation to particular medical

devices; or

particular person in relation to particular therapeutic goods;

(ca) there was no approval under subsection 32CO(1) or (2)

granted to a particular person in relation to a particular

biological; or

(d) particular therapeutic goods were or were not included in the

(e) particular therapeutic goods were or were not included in the

(eaa) a particular biological was or was not included in the

(ea) particular medical devices were or were not medical devices

of a kind included in the Register; or

(eb) particular medical devices were suspended from the Register;

(f) particular therapeutic goods were included in the Register

subject to conditions including those specified in the

certificate; or

(g) the registration, listing or inclusion in the Register of the

particular therapeutic goods had been suspended or

cancelled; or

(h) there was no declaration under section 7 which applied to

particular therapeutic goods; or

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(i) a person was or was not the holder of a licence in force under

Part 3-3; or

(j) the licence is subject to conditions including those specified

in the certificate; or

(k) there was no exemption in effect under subsection 34(1) that

applied to particular therapeutic goods or a particular class of

therapeutic goods; or

(l) there was no exemption in effect under subsection 34(2) that

applied to a particular person in relation to one or more of the

following:

(i) the manufacture of particular therapeutic goods;

(ii) a particular step in the manufacture of particular

therapeutic goods;

(iii) the manufacture of a particular class of therapeutic

goods;

(iv) a particular step in the manufacture of a particular class

of therapeutic goods; or

(m) a conformity assessment certificate has been issued relating

to a particular kind of medical device; or

(n) a conformity assessment certificate was subject to conditions

including those specified in the certificate under this section;

(o) a conformity assessment certificate was suspended.

(2) A certificate under subsection (1) may relate to more than one of

the matters referred to in paragraphs (1)(a) to (o).

(3) In proceedings for an offence against this Act or a contravention of

a civil penalty provision, a certificate under subsection (1) is prima

facie evidence of the matters specified in the certificate.

(4) In proceedings for:

(a) an offence against section 14 or 41MA; or

(b) the contravention of section 14A or 41MAA (civil penalty

provisions);

a certificate by the Secretary to the effect that:

exportation that is the subject of the proceedings; or

(d) the Secretary consented to that importation, supply or

exportation subject to conditions specified in the certificate;

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is prima facie evidence of the matters specified in the certificate.

(5) In proceedings for an offence against this Act or a contravention of

a civil penalty provision, a document purporting to be a certificate

given under this section is, unless the contrary is proved, taken to

be such a certificate and to have been duly given.

57 Delegation

(1) Subject to subsections (2), (6) and (8) to (11), the Minister or the

Secretary may, by signed instrument, delegate to:

(a) an officer of the Department; or

(b) an officer of an authority of the Commonwealth that has

functions in relation to therapeutic goods; or

(ba) an APS employee in an Agency (within the meaning of the

Public Service Act 1999) that has functions in relation to

therapeutic goods; or

appointment, declared by the regulations to be an office or

appointment the occupant or holder of which may be a

delegate under this section; or

(d) a person seconded to the Department from:

(i) an authority of a State or a Territory that has functions

relating to therapeutic goods, health or law enforcement;

(ii) a national regulatory authority of a foreign country that

has national responsibility relating to therapeutic goods,

health or law enforcement; or

(iii) an international organisation that has a function relating

to therapeutic goods, health or law enforcement;

all or any of his or her powers and functions under this Act.

(2) The powers of the Secretary under paragraph 19(1)(a), 32CK(1)(d)

or 41HB(1)(d) may be delegated under subsection (1) only to a

person referred to in paragraph (1)(a) or (c) who is registered, or

eligible for registration, in a State or internal Territory, as a

medical or dental practitioner or as a pharmacist.

(3) Subject to the regulations, the Secretary may, in such

circumstances as are prescribed, by signed instrument, delegate all

or any of his or her powers under paragraph 19(1)(a), 32CK(1)(d)

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or 41HB(1)(d) to a person who is registered, in a State or internal

Territory, as a medical or dental practitioner.

(4) A delegate under subsection (3) is, in the exercise of a delegated

power, subject to the directions of:

(a) the Secretary; or

(b) an officer of the Department authorised in writing by the

Secretary; or

(5) Without limiting the generality of matters that may be dealt with

by regulations made for the purposes of subsection (3), the

regulations may make provision in relation to the following:

(a) the persons who may be delegates;

(b) the circumstances in which delegates may grant approvals for

the purposes of paragraph 19(1)(a), 32CK(1)(d) or

41HB(1)(d);

are to be subject;

(d) requiring information to be given by delegates to the

Secretary.

(6) The powers of the Secretary under subsection 19(5), 32CM(1) or

41HC(1) may be delegated only to a person referred to in

paragraph (1)(a) or (c) who is registered, or eligible for

registration, in a State or internal Territory as a medical or dental

practitioner.

(7) The regulations may prescribe the circumstances in which, and the

requirements subject to which, delegates may grant authorities

under subsection 19(5), 32CM(1) or 41HC(1).

(8) The powers of the Secretary under section 19A or 32CO may be

delegated only to either or both of the following persons:

(a) the National Manager of the Therapeutic Goods

Administration;

(b) a person who holds, occupies or performs the duties of a

position in the Therapeutic Goods Administration prescribed

by the regulations for the purposes of this paragraph.

(9) The powers of the Secretary under section 41HD may be delegated

only to either or both of the following persons:

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(a) the National Manager of the Therapeutic Goods

Administration;

(b) a person who holds, occupies or performs the duties of a

position in the Therapeutic Goods Administration prescribed

by the regulations for the purposes of this paragraph.

(10) The power of the Minister under subsection 18A(1) may be

delegated only to the Secretary.

(10A) The power of the Minister under subsection 32CB(1) may be

delegated only to the Secretary.

(11) The power of the Minister under subsection 41GS(1) may be

delegated only to the Secretary.

58 Export certifications

(1) The Secretary may issue export certification for goods for

therapeutic use in humans, including certifications for the purposes

of the World Health Organisation Certification Scheme on the

Quality of Pharmaceutical Products Moving in International

Commerce.

(2) A State or Territory must not issue export certifications for goods

for therapeutic use in humans.

(3) Such fee as is prescribed is payable in respect of:

(a) an application for a certification under this section; and

(b) where an inspection of a manufacturing site is necessary for

the purposes of the issue of a certification under this

section—the inspection of that site.

59 Fees

(1) No fees are payable under this Act in respect of an event occurring

before 1 July 1990.

(2) Fees prescribed under this Act must not be such as to amount to

taxation.

60 Review of decisions

(1) In this section and section 60A:

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decision has the same meaning as in the Administrative Appeals

Tribunal Act 1975.

initial decision means a decision of the Secretary or of a delegate

of the Secretary:

(a) under the definition of therapeutic devices in subsection 3(1)

or under subsection 7(1) or 41BD(3); or

(aa) under subsection 7C(3); or

(ab) under section 9C or 9D; or

(b) refusing to grant a consent under section 14 or 14A; or

(ca) under Part 3-2A (Biologicals); or

(d) under Part 3-3 (manufacturing of therapeutic goods); or

(e) under Part 4-4 (conformity assessment certificates); or

(f) under Part 4-5 (including medical devices in the Register),

other than:

(i) a decision under section 41FH (selecting applications

for auditing); or

(ii) a decision about which aspects of the matters referred to

in paragraphs 41FI(1)(a) and (b) to consider in auditing

an application under Subdivision C of Division 1 of

Part 4-5; or

(g) under Part 4-6 (suspension and cancellation from the

(h) under Part 4-7 (exempting medical devices from inclusion in

the Register); or

(i) under Part 4-8 (obtaining information); or

(j) under Part 4-9 (public notification and recovery of medical

devices); or

(k) refusing to grant, or imposing conditions on a grant of, a

consent for the purposes of section 41MA or 41MAA

(non-compliance with essential principles); or

(l) under section 42DF, 42DH or 42DI.

reviewable decision means a decision of the Minister under

subsection (3).

(1A) For the avoidance of doubt, the following are not initial decisions

for the purposes of this section or section 60A:

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(a) a proposal to suspend a conformity assessment certificate

under section 41EM;

(b) a proposal to revoke a conformity assessment certificate

under section 41ET;

(d) a proposal to cancel the entry of a kind of medical device on

the Register under section 41GN.

(2) A person whose interests are affected by an initial decision may, by

notice in writing given to the Minister:

(a) in the case of a decision particulars of which are required to

be notified in the Gazette—within 90 days after those

particulars are so notified; or

(b) in any other case—within 90 days after the decision first

comes to the person’s notice;

request the Minister to reconsider the decision.

(2A) A request under subsection (2) may be accompanied by

information in support of the request.

(3) Subject to paragraph 60A(2)(b), the Minister must, as soon as

practicable after receiving a request under subsection (2),

reconsider the initial decision and, as a result of that

reconsideration, may:

(a) confirm the initial decision; or

(b) revoke the initial decision, or revoke that decision and make

a decision in substitution for the initial decision.

(3A) Subject to subsection 60A(2), in reconsidering the initial decision:

(a) the Minister must take into account any information referred

to in subsection (2A); and

(b) the Minister must not take into account any other information

provided by, or on behalf of, the person after the making of

the request, other than:

(i) information provided in response to a request from the

Minister; or

(ii) information that indicates that the quality, safety or

efficacy of therapeutic goods is unacceptable.

(3B) Paragraph (3A)(a) does not limit the information the Minister may

take into account in reconsidering the initial decision.

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(4) Where a person who has made a request under subsection (2) does

not receive notice of the decision of the Minister on

reconsideration, or (if applicable) notice that the matter has been

remitted under paragraph 60A(2)(b), within 60 days of the making

of the request, the Minister is taken to have confirmed under

subsection (3) the initial decision.

(5) After reconsideration of an initial decision, the Minister must give

the applicant a notice in writing stating the result of the

reconsideration and that the applicant may, except where

subsection 28(4) of the Administrative Appeals Tribunal Act 1975

applies, apply for a statement setting out the reasons for the

decision on reconsideration and may, subject to that Act, make an

application to the Administrative Appeals Tribunal for review of

that decision.

(6) Where written notice of the making of an initial decision is given

to a person whose interests are affected by the decision, the notice

is to include a statement to the effect that a person whose interests

are affected by the decision may:

(a) seek a reconsideration of the decision under this section; and

(b) subject to the Administrative Appeals Tribunal Act 1975, if

the person is dissatisfied with the decision upon

reconsideration, make an application to the Administrative

Appeals Tribunal for review of that decision.

(7) Any failure to comply with the requirements of subsection (5) or (6)

in relation to a decision does not affect the validity of the decision.

(8) An application may be made to the Administrative Appeals

Tribunal for review of a reviewable decision.

60A New information on review—discretion to remit

(1) This section applies only if the Secretary or an authorised delegate

makes a decision under section 25, 32DF, 32DG or 41EC in

relation to therapeutic goods.

(2) If a person (the appellant) whose interests are affected by the

decision requests the Minister to reconsider the decision, and

lodges initial new information in support of that request, the

Minister must either:

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(a) take that information into account when he or she reconsiders

the decision; or

(b) remit the matter to an authorised delegate for a fresh

decision.

(3) If the appellant applies to the Administrative Appeals Tribunal for

review of the decision on reconsideration, and lodges initial new

information or later new information (or both) in support of that

application, the Tribunal may, if the Tribunal thinks fit, remit the

matter to an authorised delegate for a fresh decision.

(4) If:

(a) the appellant applies to the Administrative Appeals Tribunal

for review of the decision on reconsideration and lodges

initial new information in support of that application; and

(b) the appellant does not lodge later new information in support

of that application;

the Tribunal must not remit the matter under subsection (3) if all of

the initial new information is information that the Minister took

into account under paragraph (2)(a) in making the decision on

reconsideration.

(5) If:

(a) the appellant lodges initial new information or later new

information (or both) in support of an application to the

Administrative Appeals Tribunal for review of the decision

on reconsideration; and

(b) the Tribunal does not remit the matter under subsection (3);

the Tribunal, in reviewing the decision on reconsideration:

Minister took into account under paragraph (2)(a) in making

the decision on reconsideration; and

(d) must not consider any other initial new information, except

initial new information that indicates that the quality, safety

or efficacy of the therapeutic goods is unacceptable; and

(e) must not consider any later new information, except later

new information that indicates that the quality, safety or

efficacy of the therapeutic goods is unacceptable.

(6) If:

(aa) the matter relates to a decision under section 25; and

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(a) the Minister or the Tribunal remits the matter; and

(b) the appellant has paid, as a further evaluation fee, the

evaluation fee that the appellant would have to pay under

section 24 on making a new application for registration of the

therapeutic goods;

the authorised delegate must make a decision under section 25,

taking into account the initial new information or later new

information (or both), as the case may be, as if a fresh application

for registration had been made.

(6AA) If:

(a) the matter relates to a decision under section 32DF or 32DG;

and

(b) the Minister or the Tribunal remits the matter; and

evaluation fee that the appellant would have to pay under

section 32DI on making a new application for inclusion of

the biological in the Register;

the authorised delegate must make a decision whether or not to

include the biological in the Register, taking into account the initial

new information or later new information (or both), as the case

may be, as if a fresh application for inclusion of the biological in

the Register had been made.

(6A) If:

(a) the matter relates to a decision under section 41EC; and

(b) the Minister or the Tribunal remits the matter; and

fee, the conformity assessment fee that the appellant would

have to pay under section 41LA on making a new application

for a conformity assessment certificate;

the authorised delegate must make a decision under section 41EC,

taking into account the initial new information or later new

information (or both), as the case may be, as if a fresh application

for a conformity assessment certificate had been made.

(7) To remove any doubt, the authorised delegate’s fresh decision is to

be treated, for the purposes of subsequent applications of section 60

and this section, as a decision under Part 3-2, 3-2A or 4-4.

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(8) In this section:

authorised delegate means a delegate of the Secretary:

(a) exercising a power to decide whether to register therapeutic

goods; or

(aa) exercising a power to decide whether to include a biological

in the Register; or

(b) exercising a power to decide whether to issue a conformity

assessment certificate.

initial new information means information that:

(a) was in existence at the time the decision referred to in

subsection (1) was made; and

(b) was not made available to the Secretary or authorised

delegate for the purpose of making that decision; and

and includes any opinions that are wholly or substantially based on

such information (whether the opinions were formed before or

after that decision was made).

later new information means information that:

(a) was in existence at the time the decision on reconsideration

was made; and

(b) was not made available to the Minister or delegate of the

Minister for the purpose of making that decision; and

and includes any opinions that are wholly or substantially based on

such information (whether the opinions were formed before or

after that decision was made).

61 Release of information

(1) In this section:

therapeutic goods information means information in relation to

therapeutic goods that is held by the Department and relates to the

performance of the Department’s functions (including functions

relating to the EC Mutual Recognition Agreement or the EFTA

Mutual Recognition Agreement).

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(2) The Secretary may:

(a) release to the World Health Organisation therapeutic goods

information relating to:

(i) notifications concerning therapeutic goods the

consumption or supply of which in Australia has been

prohibited or severely restricted, or relating to the

reasons for that action; or

(ii) the licensing status of Australian manufacturers of

therapeutic goods and their compliance with the

manufacturing principles; or

(iii) the content of reports to the Department concerning

adverse effects of therapeutic goods; or

(iv) the issue of, imposition of conditions on, or revocation

of, conformity assessment certificates;

for use in the development of policies relating to the

regulation of therapeutic goods or for the provision of

information to regulatory authorities of member countries of

the World Health Organisation; or

(b) release, in confidence, therapeutic goods information to the

World Health Organisation, being information concerning

proceedings of committees established under the regulations.

(3) The Secretary may release to an authority of the Commonwealth, a

State or a Territory that has functions relating to therapeutic goods,

therapeutic goods information relating to:

(a) reported problems and complaints concerning therapeutic

goods, the Department’s investigation of those problems and

complaints and any action that the Department has taken or

proposes to take in relation to those problems and

complaints; or

(b) reports of inspections conducted under this Act or the

regulations; or

the manufacturing of therapeutic goods; or

(d) conditions of licences; or

(e) reports of the testing of samples of therapeutic goods; or

(f) the issue of, imposition of conditions on, or revocation of,

conformity assessment certificates;

for use in the performance of those functions.

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(3A) The Secretary may release information obtained in response to a

notice under section 31A, 31AA, 31B, 32JE, 32JF, 32JG, 32JH,

41JCA, 41JD, 41JE or 41JF to:

(a) an authority of the Commonwealth, a State or a Territory that

has functions relating to therapeutic goods; and

(b) the body in a State or Territory responsible for the

registration of medical practitioners in that State or Territory;

and

registration of pharmacists in that State or Territory.

(4) The Secretary may release to a national regulatory authority of

another country, being an authority that has national responsibility

relating to therapeutic goods, therapeutic goods information

relating to:

(a) recommendations of advisory committees on therapeutic

goods supplied in or proposed for supply in Australia, and

any conditions that are or will be applicable to that supply; or

(b) decisions on the registration or listing, or the suspension or

cancellation of the registration or listing, of therapeutic

goods; or

(baa) decisions on the inclusion of biologicals in the Register, or

the suspension or cancellation of the inclusion of biologicals

in the Register; or

(ba) decisions on the inclusion of kinds of medical devices in the

kinds of medical devices in the Register; or

and the reasons for that action; or

(d) the licensing status of Australian manufacturers of

therapeutic goods and their compliance with the

manufacturing principles; or

(e) proceedings of committees established under the regulations;

(f) the issue of, imposition of conditions on, or revocation of,

conformity assessment certificates;

for use in the performance of those functions or for furthering

international co-operation in the regulation of therapeutic goods.

(4A) The Secretary may release to:

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(a) an authority of the Commonwealth, a State or a Territory that

has functions relating to therapeutic goods, health or law

enforcement; or

(b) a national regulatory authority of another country that has

national responsibility relating to therapeutic goods, health or

law enforcement; or

(ba) an international organisation that has a function relating to

therapeutic goods, health or law enforcement;

therapeutic goods information relating to one or more of the

following:

(d) action taken by the Secretary under Part 5-3;

(da) action taken by the Secretary under section 30EA (about

notification and recovery of therapeutic goods);

(e) contraventions, or possible contraventions, of Part 5-2 or

Part 5-3;

(f) any cases, or possible cases, of actual or potential tampering

with therapeutic goods;

(fa) any cases, or possible cases, of counterfeit therapeutic goods;

(g) information relating to an offence committed against this

Act, or alleged to have been committed against this Act,

involving therapeutic goods;

(h) information relating to the contravention of a civil penalty

provision, or the alleged contravention of a civil penalty

provision, involving therapeutic goods;

(i) a breach of a requirement of this Act or the regulations.

(4B) The release of therapeutic goods information mentioned in

paragraphs (4A)(g), (h) and (i) is not taken, for the purposes of

paragraph 1(d) of Information Privacy Principle 11 in section 14 of

the Privacy Act 1988, to be authorised by law.

(5) The Secretary may release to a national regulatory authority of

another country, or an international organisation, being another

country or an organisation with which the Commonwealth has

co-operative arrangements relating to the assessment or regulation

of therapeutic goods, therapeutic goods information the release of

which is consistent with those arrangements.

(5AA) The Secretary may release to a person, body or authority that is

specified, or is of a kind specified, under subsection (5AB)

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therapeutic goods information of a kind specified under that

subsection for a purpose specified under that subsection.

(5AB) For the purpose of subsection (5AA), the Minister may, by

legislative instrument, specify one or more of the following:

(a) a person, body or authority;

(b) kinds of persons, bodies or authorities;

(d) purposes.

(5A) The Secretary may release to the public therapeutic goods

information relating to any decision or action taken under this Act

or the regulations.

(5B) The release of therapeutic goods information under

subsection (5A) is not taken, for the purposes of paragraph 1(d) of

Information Privacy Principle 11 in section 14 of the Privacy Act

1988, to be authorised by law.

(5C) The Secretary may release to the public therapeutic goods

information of a kind specified under subsection (5D).

(5D) The Minister may, by legislative instrument, specify kinds of

therapeutic goods information for the purpose of subsection (5C).

(6) The Secretary may release to a person, on application by that

person, therapeutic goods information of a kind identified in the

regulations relating to:

(a) therapeutic goods included in the Register; or

(b) therapeutic goods in relation to which an application for

registration, listing or inclusion in the Register has been

made.

(6A) Regulations made for the purposes of subsection (6) may:

(a) relate to therapeutic goods generally or to a class of such

goods; and

(b) authorise the release of therapeutic goods information to

persons generally or to a class of persons.

(7) The Secretary may release therapeutic goods information:

(a) the release of which is necessary to ensure the safe use of

particular therapeutic goods; or

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(b) relating to the reasons for the withdrawal of therapeutic

goods from supply in Australia.

(8) Subject to section 25A, therapeutic goods information provided to

the Department in relation to a matter may:

(a) be used by the Department in the consideration of another

matter within its functions relating to therapeutic goods; and

(b) be provided to a committee appointed to advise the Minister

or the Secretary on matters relating to therapeutic goods,

including a committee of the National Health and Medical

Research Council.

(8A) Regulations prescribing fees in respect of applications for

information under the regulations:

(a) may include provision for the payment of deposits on

account of such fees; and

(b) may provide for fees that take into account the time spent by

officers of the Department in:

(i) searching for or retrieving information; or

(ii) making, or doing anything related to the making of, a

decision on an application; and

incurred by the Commonwealth in making available an

officer to supervise the inspection by an applicant of any

document containing information to which an application

relates.

(8C) If, under the regulations, a person is liable to pay a fee in respect of

an application for information, the Secretary must notify the

person, in writing, accordingly, and must give to the person,

together with that notification, a statement setting out the basis on

which the amount of that fee is calculated.

(10) Nothing in this or any other Act requires the Secretary to disclose

to any person, court or tribunal information referred to in

subsection 25(2E) (including as that subsection applies because of

subsection 32DE(2) or 32EB(3)) or 26(2D) if the disclosure would

constitute a breach of the Mutual Recognition Convention.

(11) This section (except subsection (10)) has effect subject to the

Freedom of Information Act 1982.

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(12) The subsections of this section permitting the release of

information have effect independently of each other.

61A Immunity from civil actions

(1) No civil action, suit or proceeding lies against:

(a) the Commonwealth; or

(b) a protected person;

in respect of loss, damage or injury of any kind suffered by another

person as a result of anything done, or omitted to be done, by a

protected person in relation to the performance or purported

performance, or in relation to the exercise or purported exercise, of

a protected person’s functions, duties or powers under this Act or

the regulations.

(2) Subsection (1) does not apply to an act or omission in bad faith.

(3) A reference in subsection (1) to anything omitted to be done

includes a reference to a failure to make a decision.

(4) In this section:

protected person means any of the following:

(a) the Minister;

(b) the Secretary;

subsection 57(1);

(d) a member of a committee established under this Act or the

regulations;

(e) an authorised person in relation to a provision of this Act

(other than this section);

(f) an authorised officer (within the meaning of the regulations);

(g) an authorised person (within the meaning of the regulations);

(h) a person assisting a person (a primary person) referred to in

paragraph (a), (b), (c), (d), (e), (f) or (g) in relation to the

performance or purported performance, or in relation to the

exercise or purported exercise, of a primary person’s

functions, duties or powers under this Act or the regulations.

ComLaw Authoritative Act C2013C00132

Chapter 7 Miscellaneous

Section 63

476 Therapeutic Goods Act 1989

63 Regulations

(1) The Governor-General may make regulations, not inconsistent with

this Act, prescribing matters:

(a) required or permitted to be prescribed by this Act; or

(b) necessary or convenient to be prescribed for carrying out or

giving effect to this Act.

(2) The regulations may:

(a) make provision in relation to:

(i) the establishment of committees to advise the Minister

or the Secretary on matters relating to therapeutic

goods; and

(ii) the functions and powers of those committees; and

(iii) the payment of remuneration and allowances to

members of those committees; and

(b) prescribe requirements for the storage and transport of

therapeutic goods; and

goods; and

(d) provide for the procedures to be followed by the Department

in the sampling and testing of therapeutic goods; and

(da) provide for the periods within which evaluations under

section 25 in relation to specified therapeutic goods or

specified classes of such goods are to be completed; and

(daa) provide for the periods within which evaluations under

section 32DE in relation to specified biologicals or specified

classes of biologicals are to be completed; and

(db) provide for the periods within which decisions under

section 41EP to revoke suspensions of conformity

assessment certificates are to be made, in cases where

applications for revocation have been made under

paragraph 41EP(2)(a); and

(dc) provide for the periods within which decisions on

applications for the issuing of conformity assessment

certificates under Part 4-4 are to be made if considering the

applications involves examining the design of medical

devices; and

(dd) provide for the periods within which decisions under

section 41GD to revoke suspensions of entries on the

ComLaw Authoritative Act C2013C00132

Miscellaneous Chapter 7

Section 63

Therapeutic Goods Act 1989 477

revocation have been made under paragraph 41GD(2)(a); and

(e) prescribe requirements for informational material that is

included with therapeutic goods; and

(f) make provision for the transfer of registration, listing or

inclusion in the Register of therapeutic goods and of licences;

and

(g) make provision for the testing of therapeutic goods, the

inspection of manufacturing operations or the evaluation of

data concerning therapeutic goods by the Department at the

request of persons; and

(h) prescribe fees in respect of matters under this Act or the

regulations; and

(j) prescribe penalties not exceeding 10 penalty units for

offences against the regulations.

(3) The regulations may:

(a) prescribe different fees under this Act in relation to:

(i) different classes of goods; or

(ii) in the case of fees under Part 3-3—different steps in the

manufacture of goods; or

(b) provide for the refund, reduction or waiving of fees or

charges in cases identified in the regulations; or

manufactured by licence holders that the Secretary may,

under subsection 37(2), require to be supplied by the holders

of licences at the time of payment of annual licensing charges

in respect of the licences.

(3A) The regulations may provide for:

(a) the granting of a licence or permission to import or export

therapeutic goods; and

(b) licences or permissions to import or export therapeutic goods

to be subject to conditions or requirements; and

therapeutic goods; and

(d) the surrender of a licence or permission to import or export

therapeutic goods; and

(e) the revocation of a licence or permission to import or export

therapeutic goods.

ComLaw Authoritative Act C2013C00132

Chapter 7 Miscellaneous

Section 63

478 Therapeutic Goods Act 1989

(4) The regulations may make provision for a matter by applying,

adopting or incorporating, with or without modification, any matter

contained in an instrument:

(a) as that instrument is in force at the time when the regulations

take effect; or

(b) as that instrument is in force from time to time.

(5) For the purposes of section 2, regulations may be made before the

commencement of this Act as if this Act were in force, but do not

come into effect on a day earlier than the day on which this Act

commences.

ComLaw Authoritative Act C2013C00132

Repeal and transitional provisions Chapter 8

Section 66

Therapeutic Goods Act 1989 479

Chapter 8—Repeal and transitional

provisions

66 Transitional arrangements for goods required to be registered or

listed

(1) This section applies to therapeutic goods in relation to a person if,

immediately before the commencement of this Act, the person was

supplying goods of that kind in Australia for use in humans.

(2) Where:

(a) this section applies to therapeutic goods in relation to a

person; and

(b) the Secretary is not aware of the person having been

convicted of an offence against a law of the Commonwealth,

of a State or of an internal Territory in respect of goods of

that kind during the period of 2 years ending on the

commencement of this Act; and

of the person having, during that period, imported goods of

that kind into Australia otherwise than in accordance with

regulations in force under the Customs Act 1901;

subsections 20(1) and (2) do not apply to goods of that kind in

relation to the person during the period of 3 months after that

commencement.

(3) Where:

(a) this section applies to therapeutic goods in relation to a

person; and

(b) the person makes an application for registration or listing of

goods of that kind in accordance with section 23 and within 3

months after the commencement of this Act;

then:

relation to the person during the period of 6 months after that

commencement or before the end of such longer period as the

Secretary specifies by notice published in the Gazette before

the end of that first-mentioned period; and

ComLaw Authoritative Act C2013C00132

Chapter 8 Repeal and transitional provisions

Section 66

480 Therapeutic Goods Act 1989

(d) subsection 20(2) does not apply to goods of that kind in

relation to the person during the period of 12 months after

that commencement or before the end of such longer period

as the Secretary specifies by notice published in the Gazette

before the end of that first-mentioned period.

(3A) If, on an application under subsection (3), goods have been

registered without having been evaluated, the Secretary may, if he

or she thinks it appropriate, give the person in relation to whom the

goods are registered written notice that the goods are to be

evaluated to determine whether they should continue to be

registered.

(4) A person who makes an application in accordance with subsection (3)

is not required to pay:

(a) any application fee for the registration or listing of the goods

to which the application relates; or

(b) in the case of an application for the registration of goods—

any fee for the evaluation of the goods for registration;

but where the goods are later evaluated to determine whether the

goods should continue to be registered, such fee as is prescribed is

payable in respect of that evaluation.

(4A) In relation to an evaluation conducted for the purposes of this

section:

(a) section 25 has effect as if:

(i) the person in respect of whom the goods are registered

were an applicant for the registration of the goods; and

(ii) the reference in paragraph (1)(b) to an evaluation fee

under section 24 were a reference to a fee payable under

subsection (4) of this section; and

(b) sections 24A, 24B and 24C have effect as if any reference in

those sections to section 24 were a reference to subsection (4)

of this section; and

(4B) If, on an application under subsection (3), goods have been listed

without consideration of the matters mentioned in paragraphs

26(1)(c) to (m), the Secretary may, if he or she thinks it

appropriate, give the person in relation to whom the goods are

listed written notice that the Secretary intends to determine

whether the goods should continue to be listed.

ComLaw Authoritative Act C2013C00132

Repeal and transitional provisions Chapter 8

Section 67

Therapeutic Goods Act 1989 481

(4C) If notice is given under subsection (4B), section 26 applies as if the

person in relation to whom the goods are listed were an applicant

for the listing of the goods.

(5) Section 21 does not apply, during the period of 15 months after the

commencement of this Act or during such longer period as the

Secretary specifies by notice published in the Gazette before the

end of that first-mentioned period, to any goods.

(6) Where a person suffers any kind of loss, damage or injury caused

by, or arising out of, the use by the person of therapeutic goods to

which this section applies, no liability in respect of that loss,

damage or injury attaches to the Commonwealth, the Secretary or

any delegate of the Secretary.

67 Transitional provision for therapeutic goods for export only

Section 20 does not apply, during the period of 6 months after the

commencement of this Act, to therapeutic goods manufactured in

Australia solely for export from Australia.

68 Transitional arrangements for Part 3-3

(1) This section applies to a step in the manufacture of therapeutic

goods in relation to a person in relation to premises in Australia if,

before the commencement of this Act, the person was carrying out

that step in relation to goods of that kind at those premises.

(2) Where:

(a) this section applies to a step in the manufacture of therapeutic

goods in relation to a person in relation to premises; and

(b) the Secretary is not aware of the person having been

convicted of an offence against a law of the Commonwealth,

of a State or of an internal Territory in respect of goods of

that kind during the period of 2 years ending on the

commencement of this Act;

subsection 35(1) does not apply the carrying out of that step by the

person in relation to goods of that kind at those premises during the

period of 4 months after that commencement.

(3) Where:

(a) this section applies to a step in the manufacture of therapeutic

goods in relation to a person in relation to premises; and

ComLaw Authoritative Act C2013C00132

Chapter 8 Repeal and transitional provisions

Section 69

482 Therapeutic Goods Act 1989

(b) the person makes an application for a licence to carry out that

step in relation to goods of that kind at those premises in

accordance with section 37 and within 4 months after the

commencement of this Act;

subsection 35(1) does not apply to the carrying out of that step by

the person in relation to goods of that kind at those premises until

the application is determined.

69 Continuation of standards and requirements

Any standards that were in force immediately before the

commencement of this Act under Part 2 of the Therapeutic Goods

Act 1966, and any requirements that were in force at that time

under section 15 of the Therapeutic Goods Act 1966, continue in

force as if they were standards made under Part 3-1 of this Act.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

Therapeutic Goods Act 1989 483

Endnotes

Endnote 1—Legislation history

This endnote sets out details of the legislation history of the Therapeutic Goods

Act 1989.

Act Number

and year

Assent

date

Commencement

date

Application,

saving and

transitional

provisions

Therapeutic Goods Act

1989

21, 1990 17 Jan 1990 15 Feb 1991

Community Services and

Health Legislation

Amendment Act (No. 2)

1990

141, 1990 28 Dec

1990

Part 8 (ss. 78–81): (a) —

Community Services and

Health Legislation

Amendment Act 1991

84, 1991 26 June

1991

s. 14: 1 Aug 1991 (see s.

2(2) and Gazette 1991,

No. S207)

Remainder: Royal

Assent

ss. 33–36

Therapeutic Goods

Amendment Act 1991

204, 1991 24 Dec

1991

24 Dec 1991 ss. 4(2), 10(2) and

13(2)

Health, Housing and

Community Services

Legislation Amendment

Act 1992

88, 1992 30 June

1992

ss. 82–88: Royal Assent

(b)

s. 83(2)

Health and Community

Services Legislation

Amendment Act (No. 2)

1993

76, 1993 25 Nov

1993

ss. 29(h) and 30–32: 14

Feb 1994 (see Gazette

1994, No. GN5)

ss. 29(i), 37(b), 38(b), 47

and 50(1)(d): 2 May

1994 (see Gazette 1994,

No. S149)

Remainder: Royal

Assent

ss. 33(2), 36(2),

41(2), 49(2), 50(2)

and 51(2)

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

484 Therapeutic Goods Act 1989

Act Number

and year

Assent

date

Commencement

date

Application,

saving and

transitional

provisions

Customs, Excise and

Bounty Legislation

Amendment Act 1995

85, 1995 1 July 1995 s. 12 (items 5, 6): 1 July

1995 (c)

s. 18: Royal Assent (c)

s. 18

Therapeutic Goods

Amendment Act 1996

6, 1996 11 June

1996

11 June 1996 s. 84

Therapeutic Goods

Amendment Act 1997

116, 1997 7 July 1997 Schedule 1 (Part 2

[items 2–14]): 1 Jan

1999 (see Gazette 1998,

No. S609)

Remainder: Royal

Assent

—

as amended by

Therapeutic Goods

Legislation

Amendment Act 1999

3, 1999 29 Mar

1999

(see 3, 1999 below) —

Audit (Transitional and

Miscellaneous)

Amendment Act 1997

152, 1997 24 Oct

1997

Schedule 2 (item 1249):

1 Jan 1998 (see Gazette

1997, No. GN49) (d)

—

Therapeutic Goods

Legislation Amendment

Act 1998

34, 1998 17 Apr

1998

17 Apr 1998 —

Therapeutic Goods

Legislation Amendment

Act 1999

3, 1999 29 Mar

1999

Schedule 2: (e)

Remainder: 1 Apr 1999

(see Gazette 1999, No.

S143)

—

Public Employment

(Consequential and

Transitional)

Amendment Act 1999

146, 1999 11 Nov

1999

Schedule 1 (items 936–

938): 5 Dec 1999 (see

Gazette 1999, No. S584)

(f)

—

Therapeutic Goods

Amendment Act 2000

12, 2000 31 Mar

2000

31 Mar 2000 —

Therapeutic Goods

Amendment Act (No. 2)

2000

56, 2000 30 May

2000

30 May 2000 Sch. 1 (item 5)

[see Endnote 3]

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

Therapeutic Goods Act 1989 485

Act Number

and year

Assent

date

Commencement

date

Application,

saving and

transitional

provisions

Therapeutic Goods

Amendment Act (No. 3)

2000

120, 2000 12 Sept

2000

Schedule 1: 10 Oct 2000

Remainder: Royal

Assent

Sch. 1 (items 4, 6,

8, 10, 17) [see

Endnote 3]

Gene Technology

(Consequential

Amendments) Act 2000

170, 2000 21 Dec

2000

22 June 2001 (see s. 2) —

Therapeutic Goods

Amendment Act 2001

14, 2001 22 Mar

2001

22 Sept 2001 Sch. 1 (item 36)

[see Endnote 3]

Australia New Zealand

Food Authority

Amendment Act 2001

81, 2001 10 July

2001

s. 2(6): Royal Assent (g)

Schedule 3 (item 8):

1 July 2002 (see Gazette

2002, No. GN30) (g)

s. 2(6) [see

Endnote 3]

Health and Aged Care

Legislation Amendment

(Application of Criminal

Code) Act 2001

111, 2001 17 Sept

2001

17 Sept 2001 s. 4 [see Endnote

Therapeutic Goods

Amendment Act (No. 1)

2002

23, 2002 4 Apr 2002 4 Apr 2002 —

Therapeutic Goods

Amendment (Medical

Devices) Act 2002

24, 2002 4 Apr 2002 Schedule 1: 4 Oct 2002

Schedule 2: (h)

Remainder: Royal

Assent

Sch. 1 (items 38,

46, 55) [see

Endnote 3]

s. 2(1) (item 3)

(rep. by 140,

2007, Sch. 1

[item 7])

as amended by

Therapeutic Goods

and Other Legislation

Amendment Act 2002

56, 2002 3 July 2002 Schedule 3 (item 22):

(see 56, 2002 below)

—

Therapeutic Goods

Amendment Act

(No. 1) 2006

39, 2006 3 May 2006 Schedule 1 (item 158):

(h)

—

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

486 Therapeutic Goods Act 1989

Act Number

and year

Assent

date

Commencement

date

Application,

saving and

transitional

provisions

Therapeutic Goods

Amendment Act 2007

140, 2007 14 Sept

2007

Schedule 1 (items 7, 8):

3 Oct 2007

—

Therapeutic Goods and

Other Legislation

Amendment Act 2002

56, 2002 3 July 2002 Schedule 1 (items 6, 7),

Schedule 3 (items 4, 22)

and Schedule 4 (item 1):

(i)

Remainder: Royal

Assent

Sch. 3 (items 20,

21) [see Endnote

Therapeutic Goods

Amendment Act (No. 1)

2003

39, 2003 27 May

2003

Schedule 1 (items 1–19)

and Schedule 2: 27 Nov

2003

Schedule 1 (item 79): (j)

Remainder: Royal

Assent

Sch. 1 (items 41,

55, 60) [see

Endnote 3]

US Free Trade

Agreement

Implementation Act

2004

120, 2004 16 Aug

2004

Schedule 7: 1 Jan 2005 Sch. 7 (item 7)

[see Endnote 3]

Financial Framework

Legislation Amendment

Act 2005

8, 2005 22 Feb

2005

s. 4 and Schedule 1

(items 493, 496): Royal

Assent

s. 4 and Sch. 1

(item 496) [see

Endnote 3]

Therapeutic Goods

Amendment Act (No. 2)

2006

2, 2006 1 Mar 2006 Schedule 1: 3 Apr 2006

(see F2006L00889)

Remainder: Royal

Assent

Sch. 1 (item 15)

[see Endnote 3]

Therapeutic Goods

Amendment (Repeal of

Ministerial responsibility

for approval of RU486)

Act 2006

5, 2006 3 Mar 2006 3 Mar 2006 s. 3 [see Endnote

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

Therapeutic Goods Act 1989 487

Act Number

and year

Assent

date

Commencement

date

Application,

saving and

transitional

provisions

Therapeutic Goods

Amendment Act (No. 1)

2006

39, 2006 3 May 2006 Schedule 1 (items 1–117,

119–157): 31 May 2006

Schedule 1 (item 118):

27 Nov 2003

Remainder: Royal

Assent

s. 2(1) (item 5)

(rep. by 140,

2007, Sch. 1

[item 4])

as amended by

Therapeutic Goods

Amendment Act 2007

140, 2007 14 Sept

2007

Schedule 1 (items 4–6):

3 Oct 2007

—

National Health and

Medical Research

Council Amendment Act

2006

50, 2006 9 June 2006 Schedule 1: 1 July 2006

Remainder: Royal

Assent

—

Therapeutic Goods

Amendment Act (No. 3)

2006

96, 2006 5 Sept 2006 5 Sept 2006 —

Therapeutic Goods

Amendment Act 2007

140, 2007 14 Sept

2007

3 Oct 2007 —

Therapeutic Goods

Amendment (Poisons

Standard) Act 2008

9, 2008 20 Mar

2008

20 Mar 2008 —

Statute Law Revision

Act 2008

73, 2008 3 July 2008 Schedule 1 (item 47): (k) —

Therapeutic Goods

Legislation Amendment

(Annual Charges) Act

2008

96, 2008 3 Oct 2008 Schedule 1 (items 1–3):

1 Jan 2009 (see

F2008L04263)

Sch. 1 (item 3)

[see Endnote 3]

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

488 Therapeutic Goods Act 1989

Act Number

and year

Assent

date

Commencement

date

Application,

saving and

transitional

provisions

Therapeutic Goods

Amendment (Medical

Devices and Other

Measures) Act 2009

38, 2009 17 June

2009

Schedules 1, 2 and 5–7:

18 June 2009

Schedule 3: 1 Dec 2009

(see F2009L03387)

Schedule 4: 1 July 2009

Remainder: Royal

Assent

Sch. 2 (item 4),

Sch. 3 (item 23),

Sch. 4 (item 20),

Sch. 5 (item 3)

and Sch. 6

(item 12) [see

Endnote 3]

Therapeutic Goods

Amendment (2009

Measures No. 1) Act

2009

76, 2009 27 Aug

2009

Schedules 1, 3, 6 and

Schedule 7 (items 1–28):

28 Aug 2009

Schedule 2: 25 Feb 2010

(see F2009L03994)

Schedule 4: 1 July 2011

Schedule 5: 8 Feb 2010

(see F2009L03994)

Schedule 7 (items 29–

58): 25 Jan 2010 (see

F2009L03994)

Remainder: Royal

Assent

Sch. 1 (item 7),

Sch. 2 (items 25,

26), Sch. 3

(item 16), Sch. 5

(item 5), Sch. 6

(item 14) and Sch.

7 (items 26–28,

56–59) [see

Endnote 3]

Therapeutic Goods

Amendment (2009

Measures No. 2) Act

2009

96, 2009 29 Sept

2009

Schedule 1: 1 July 2010

Schedule 2 and

Schedule 3 (items 1–7):

30 Sept 2009

Schedule 3 (items 8–10):

29 Mar 2010

Remainder: Royal

Assent

Sch. 1 (item 13),

Sch. 2 (item 4)

and Sch. 3

(items 7, 10) [see

Endnote 3]

Statute Law Revision

Act 2010

8, 2010 1 Mar 2010 Schedule 5 (item 124):

Royal Assent

Schedule 5

(item 137(a)): (l)

—

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

Therapeutic Goods Act 1989 489

Act Number

and year

Assent

date

Commencement

date

Application,

saving and

transitional

provisions

Therapeutic Goods

Amendment (2009

Measures No. 3) Act

2010

54, 2010 31 May

2010

Schedule 1: 31 May

2011

Schedules 2–6: 1 June

2010

Remainder: Royal

Assent

Sch. 1 (items 58–

60), Sch. 2

(items 15, 16),

Sch. 3 (item 3),

Sch. 4 (item 6),

Sch. 5 (item 2)

and Sch. 6

(item 20) [see

Endnote 3]

Therapeutic Goods

Amendment (2010

Measures No. 1) Act

2010

141, 2010 15 Dec

2010

Schedule 1 and

Schedule 2 (items 7A–

21): 16 Dec 2010

Schedule 1A and

Schedule 2 (items 1A–

7): 12 Jan 2011

Schedule 2 (items 22,

23): (m)

Remainder: Royal

Assent

Sch. 1A (item 10)

and Sch. 2

(items 7, 21) [see

Endnote 3]

Statute Law Revision

Act 2011

5, 2011 22 Mar

2011

Schedule 7 (item 140):

19 Apr 2011

—

Acts Interpretation

Amendment Act 2011

46, 2011 27 June

2011

Schedule 2 (items 1150–

1156) and Schedule 3

(items 10, 11): 27 Dec

2011

Sch. 3 (items 10,

11) [see Endnote

Therapeutic Goods

Amendment (2011

Measures No. 1) Act

2011

77, 2011 25 July

2011

26 July 2011 Sch. 1 (items 6–8)

[see Endnote 3]

Statute Law Revision

Act 2012

136, 2012 22 Sept

2012

Schedule 6 (items 85–

88): Royal Assent

—

Personal Liability for

Corporate Fault Reform

Act 2012

180, 2012 10 Dec

2012

Schedule 5: 11 Dec 2012 —

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

490 Therapeutic Goods Act 1989

(a) The Therapeutic Goods Act 1989 was amended by Part 8 (sections 78–81)

only of the Community Services and Health Legislation Amendment Act

(No. 2) 1990, subsection 2(6) of which provides as follows:

(6) Part 8 commences immediately after the commencement of the

Therapeutic Goods Act 1989.

The Therapeutic Goods Act 1989 came into operation on 15 February 1991.

(b) The Therapeutic Goods Act 1989 was amended by sections 82–88 only of the

Health, Housing and Community Services Legislation Amendment Act 1992,

subsection 2(1) of which provides as follows:

(1) Subject to this section, this Act commences on the day on which it

receives the Royal Assent.

(c) The Therapeutic Goods Act 1989 was amended by the Customs, Excise and

Bounty Legislation Amendment Act 1995, subsections 2(1) and (5) of which

provide as follows:

(1) Subject to subsections (2), (3), (4), (5) and (6), this Act commences on

the day on which it receives the Royal Assent.

(5) Schedules 2 and 3, items 1, 26 to 45, 49 to 53 and 56 and 67 of

Schedule 4, Schedule 6, items 6 to 11 of Schedule 7 and Schedules 8 and

10 commence on 1 July 1995.

(d) The Therapeutic Goods Act 1989 was amended by Schedule 2 (item 1249)

only of the Audit (Transitional and Miscellaneous) Amendment Act 1997,

subsection 2(2) of which provides as follows:

(2) Schedules 1, 2 and 4 commence on the same day as the Financial

Management and Accountability Act 1997.

(e) Subsection 2(3) of the Therapeutic Goods Legislation Amendment Act 1999

provides as follows:

(3) Schedule 2 is taken to have commenced immediately after the

commencement of Part 2 of Schedule 1 to the Therapeutic Goods

Amendment Act 1997.

Part 2 of Schedule 1 commenced on 1 January 1999 (see Gazette 1998, No.

S609). .

(f) The Therapeutic Goods Act 1989 was amended by Schedule 1 (items 936–

938) only of the Public Employment (Consequential and Transitional)

Amendment Act 1999, subsections 2(1) and (2) of which provide as follows:

(1) In this Act, commencing time means the time when the Public Service

Act 1999 commences.

(2) Subject to this section, this Act commences at the commencing time.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

Therapeutic Goods Act 1989 491

(g) The Therapeutic Goods Act 1989 was amended by Schedule 3 (item 8) only

of the Australia New Zealand Food Authority Amendment Act 2001,

subsections 2(1)(a), (2) and (5) of which provide as follows:

(1) The following provisions commence on the day on which this Act

receives the Royal Assent:

(a) sections 1, 2 and 3;

(2) Part 1 of Schedule 1 (other than item 120A), and Schedule 3, commence

on the first day after the commencement of this section on which an

amendment of the Australia New Zealand Joint Food Standards

Agreement comes into force in accordance with Article 10 of that

Agreement.

(5) As soon as practicable after the commencement of the following

provisions:

(a) Part 1 of Schedule 1 (other than item 120A);

(b) Schedule 3;

the Minister must cause to be published in the Gazette a notice

specifying the day on which those provisions commenced.

(h) The proposed amendments made by Schedule 2 (items 1–11 and 13–23) of

the Therapeutic Goods Amendment (Medical Devices) Act 2002 and

Schedule 2 (item 12) of the Therapeutic Goods Amendment (Medical

Devices) Act 2002 as amended by Schedule 1 (item 158) of the Therapeutic

Goods Amendment Act (No. 1) 2006 were repealed by Schedule 1 (item 8) of

the Therapeutic Goods Amendment Act 2007 before they commenced.

(i) Subsection 2(1) (items 2(b), 4, 6 and 7) of the Therapeutic Goods and Other

Legislation Amendment Act 2002 provides as follows:

(1) Each provision of this Act specified in column 1 of the table commences,

or is taken to have commenced, on the day or at the time specified in

column 2 of the table.

Commencement information

Column 1 Column 2 Column 3

Provision(s) Commencement Date/Details

2. Schedule 1,

items 6 and 7

The later of:

(b) immediately after Schedule 1 to the Therapeutic Goods Amendment (Medical Devices) Act 2002 commences

4 October 2002

4. Schedule 3,

item 4

Immediately after item 22 of Schedule 3

commences, subject to subsection (3)

4 October 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

492 Therapeutic Goods Act 1989

Commencement information

Column 1 Column 2 Column 3

Provision(s) Commencement Date/Details

6. Schedule 3,

item 22

Immediately after Schedule 1 to the Therapeutic

Goods Amendment (Medical Devices) Act 2002

commences, subject to subsection (3)

4 October 2002

7. Schedule 4,

item 1

Immediately after Schedule 1 to the Therapeutic

Goods Amendment (Medical Devices) Act 2002

commences

4 October 2002

(j) Subsection 2(1) (item 4) of the Therapeutic Goods Amendment Act (No. 1)

2003 provides as follows:

(1) Each provision of this Act specified in column 1 of the table commences,

or is taken to have commenced, on the day or at the time specified in

column 2 of the table.

Provision(s) Commencement Date/Details

4. Schedule 1,

item 79

Immediately after the commencement of the

Health and Aged Care Legislation Amendment

(Application of Criminal Code) Act 2001

17 September

2001

(k) Subsection 2(1) (item 31) of the Statute Law Revision Act 2008 provides as

follows:

(1) Each provision of this Act specified in column 1 of the table commences,

or is taken to have commenced, in accordance with column 2 of the table.

Any other statement in column 2 has effect according to its terms.

Provision(s) Commencement Date/Details

31. Schedule 1,

item 47

Immediately after the commencement of item 79 of

Schedule 1 to the Therapeutic Goods Amendment

Act (No. 1) 2003.

17 September

2001

(l) Subsection 2(1) (items 31 and 38) of the Statute Law Revision Act 2010

provides as follows:

(1) Each provision of this Act specified in column 1 of the table commences,

or is taken to have commenced, in accordance with column 2 of the table.

Any other statement in column 2 has effect according to its terms.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 1—Legislation history

Therapeutic Goods Act 1989 493

Provision(s) Commencement Date/Details

31. Schedule 5,

items 1 to 51

The day this Act receives the Royal Assent. 1 March 2010

38. Schedule 5,

Parts 2 and 3

Immediately after the provision(s) covered by table

item 31.

1 March 2010

(m) Subsection 2(1) (item 5) of the Therapeutic Goods Amendment (2010

Measures No. 1) Act 2010 provides as follows:

(1) Each provision of this Act specified in column 1 of the table commences,

or is taken to have commenced, in accordance with column 2 of the table.

Any other statement in column 2 has effect according to its terms.

Provision(s) Commencement Date/Details

5. Schedule 2,

Part 3

The later of:

(a) immediately after the commencement of the provision(s) covered by table item 2; and

(b) immediately after the commencement of Schedule 1 to the Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010.

31 May 2011

(paragraph (b)

applies)

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

494 Therapeutic Goods Act 1989

Endnote 2—Amendment history

This endnote sets out the amendment history of the Therapeutic Goods Act

1989.

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Chapter 1

Heading to Part 1 ...........................rep. No. 24, 2002

Heading to Chapt. 1.......................ad. No. 24, 2002

s. 3 .................................................am. No. 141, 1990; No. 84, 1991; No. 88, 1992; No. 76, 1993; No. 6,

1996; No. 116, 1997; No. 34, 1998; No. 3, 1999; Nos. 12, 56, 120 and

170, 2000; Nos. 14, 81 and 111, 2001; No. 24, 2002 (as am. by No. 56,

2002); No. 56, 2002; No. 39, 2003; Nos. 5, 39 and 50, 2006; No. 9, 2008;

Nos. 38, 76 and 96, 2009; Nos. 54 and 141, 2010; No. 5, 2011

ss. 3AA, 3AB ................................ad. No. 76, 2009

s. 3A ..............................................ad. No. 116, 1997

am. No. 12, 2000

s. 3B ..............................................ad. No. 56, 2002

s. 3C ..............................................ad. No. 38, 2009

s. 4 .................................................rs. No. 204, 1991; No. 76, 1993; No. 3, 1999

am. No. 24, 2002

s. 5 .................................................am. No. 39, 2006

s. 5A ..............................................ad. No. 111, 2001

rs. No. 39, 2006

s. 6 .................................................am. No. 76, 1993

s. 6AA ...........................................ad. No. 6, 1996

am. No. 111, 2001

rep. No. 5, 2006

s. 6AB............................................ad. No. 6, 1996

rep. No. 5, 2006

s. 6A ..............................................ad. No. 76, 1993

am. No. 146, 1999; No. 24, 2002

rep. No. 56, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 495

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

ss. 6AAA–6AAD...........................ad. No. 56, 2002

s. 6AAE.........................................ad. No. 56, 2002

am. No. 56, 2002; No. 54, 2010

ss. 6B, 6C ......................................ad. No. 76, 1993

s. 7 .................................................am. No. 76, 1993; No. 24, 2002; No. 141, 2010

s. 7A ..............................................ad. No. 76, 1993

s. 7B ..............................................ad. No. 76, 1993

am. No. 24, 2002; No. 54, 2010

s. 7C ..............................................ad. No. 76, 2009

s. 7D ..............................................ad. No. 141, 2010

s. 8 .................................................am. No. 84, 1991; No. 6, 1996; No. 111, 2001; No. 38, 2009

s. 9 .................................................am. No. 54, 2010

Chapter 2

Chapt. 2 .........................................ad. No. 24, 2002

s. 9A ..............................................ad. No. 24, 2002

am. No. 56, 2002; No. 54, 2010

s. 9B ..............................................ad. No. 24, 2002

am. No. 140, 2007

s. 9C ..............................................ad. No. 24, 2002

am. No. 38, 2009

s. 9D ..............................................ad. No. 24, 2002

am. Nos. 54 and 141, 2010; No. 77, 2011

s. 9E...............................................ad. No. 24, 2002

Chapter 3

Heading to Part 2 ...........................rep. No. 24, 2002

Heading to Chapt. 3.......................ad. No. 24, 2002

Note to Chapt. 3.............................ad. No. 24, 2002

rs. No. 140, 2007

Part 3-1

Heading to Part 3-1........................ad. No. 24, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

496 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 10 ...............................................am. No. 24, 2002; Nos. 38 and 76, 2009; No. 46, 2011

Note to s. 10(1)..............................ad. No. 76, 2009

s. 10A ............................................ad. No. 24, 2002

ss. 11, 12........................................rep. No. 76, 2009

Heading to s. 13.............................am. No. 76, 2009

s. 13 ...............................................rs. No. 38, 2009

s. 13A ............................................ad. No. 76, 2009

Subhead. to s. 14(5) .......................rs. No. 54, 2010

s. 14 ...............................................am. No. 85, 1995; No. 6, 1996; No. 39, 2003

rs. No. 39, 2006

am. No. 38, 2009; No. 54, 2010

Note to s. 14(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 14(1) ...........................ad. No. 180, 2012

Note to s. 14(2)..............................ad. No. 180, 2012

Note to s. 14(6)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 14(6) ...........................ad. No. 180, 2012

Note to s. 14(7)..............................ad. No. 180, 2012

Note to s. 14(10)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 14(10) .........................ad. No. 180, 2012

Note to s. 14(11)............................ad. No. 180, 2012

s. 14A ............................................ad. No. 39, 2006

am. No. 54, 2010

s. 14B ............................................ad. No. 39, 2006

s. 15 ...............................................am. No. 6, 1996; No. 111, 2001

rs. No. 39, 2006

am. No. 38, 2009

Note to s. 15(2)

Renumbered Note 1 ...................No. 180, 2012

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 497

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Note 2 to s. 15(2) ...........................ad. No. 180, 2012

Note to s. 15(3)..............................ad. No. 180, 2012

s. 15AA .........................................ad. No. 39, 2006

s. 15AB..........................................ad. No. 54, 2010

Part 3-2

Heading to Part 3 ...........................rep. No. 24, 2002

Heading to Part 3-2........................ad. No. 24, 2002

Division 1

s. 15A ............................................ad. No. 24, 2002

s. 15B ............................................ad. No. 54, 2010

s. 16 ...............................................am. No. 141, 1990; No. 84, 1991; No. 76, 1993; No. 14, 2001; No. 24,

2002

s. 17 ...............................................am. No. 84, 1991; No. 3, 1999; No. 56, 2002

rep. No. 24, 2002

s. 18 ...............................................rs. No. 204, 1991

am. No. 120, 2000

s. 18A ............................................ad. No. 23, 2002

am. No. 38, 2009; No. 54, 2010

Note to s. 18A(7)

Renumbered Note 1 ...................No. 39, 2006

Note 2 to s. 18A(7) ........................ad. No. 39, 2006

Note to s. 18A(12) .........................am. No. 39, 2006

s. 19 ...............................................am. No. 204, 1991; No. 6, 1996; No. 120, 2000; No. 54, 2010

s. 19A ............................................ad. No. 6, 1996

am. No. 76, 2009

s. 19B ............................................ad. No. 39, 2006

am. No. 38, 2009

Note 3 to s. 19B(1) ........................ad. No. 180, 2012

Note to s. 19B(2)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 19B(2) ........................ad. No. 180, 2012

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

498 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

ss. 19C, 19D ..................................ad. No. 39, 2006

Heading to s. 20.............................rs. No. 6, 1996; No. 39, 2006

s. 20 ...............................................am. No. 204, 1991; No. 85, 1995; No. 6, 1996; No. 56, 2000; No. 111,

2001; No. 23, 2002; No. 39, 2003; No. 39, 2006; No. 38, 2009

Note to s. 20(1)..............................ad. No. 23, 2002

rep. No. 39, 2006

Note to s. 20(1A) ...........................ad. No. 111, 2001

rep. No. 39, 2006

s. 20A ............................................ad. No. 39, 2006

s. 21 ...............................................am. No. 204, 1991; No. 6, 1996; No. 111, 2001; No. 23, 2002; No. 38,

2009

s. 21A ............................................ad. No. 39, 2006

am. No. 38, 2009

Note to s. 21A(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 21A(1) ........................ad. No. 180, 2012

Note to s. 21A(2) ...........................ad. No. 180, 2012

Note to s. 21A(5)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 21A(5) ........................ad. No. 180, 2012

Note to s. 21A(6) ...........................ad. No. 180, 2012

s. 21B ............................................ad. No. 39, 2006

s. 22 ...............................................am. No. 204, 1991; No. 6, 1996; No. 120, 2000; Nos. 14 and 111, 2001;

No. 23, 2002; No. 39, 2003; No. 39, 2006; Nos. 38 and 96, 2009

Note 1 to s. 22(7AB) .....................rs. No. 39, 2006

Note 3 to s. 22(7AB) .....................ad. No. 180, 2012

s. 22AA .........................................ad. No. 39, 2006

s. 22A ............................................ad. No. 204, 1991

am. No. 6, 1996; No. 111, 2001; No. 39, 2003

rs. No. 39, 2006

am. No. 38, 2009

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 499

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Note to s. 22A(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 22A(1) ........................ad. No. 180, 2012

Note to s. 22A(2) ...........................ad. No. 180, 2012

s. 22B ............................................ad. No. 39, 2006

Division 2

s. 23AA .........................................ad. No. 6, 1996

rep. No. 5, 2006

s. 23 ...............................................am. No. 84, 1991; No. 76, 1993; No. 141, 2010

s. 24 ...............................................am. Nos. 84 and 204, 1991; No. 77, 2011

s. 24A ............................................ad. No. 84, 1991

am. No. 204, 1991; No. 77, 2011

s. 24B ............................................ad. No. 84, 1991

am. No. 24, 2002

s. 24C ............................................ad. No. 84, 1991

Heading to s. 24D..........................am. No. 77, 2011

s. 24D ............................................ad. No. 204, 1991

am. No. 56, 2002; No. 76, 2009; No. 77, 2011

s. 24E.............................................ad. No. 88, 1992

Heading to s. 25.............................rs. No. 6, 1996

s. 25 ...............................................am. Nos. 84 and 204, 1991; No. 76, 1993; No. 116, 1997; No. 12, 2000;

Nos. 24 and 56, 2002; No. 39, 2003; No. 120, 2004; No. 2, 2006; Nos. 54

and 141, 2010

Note to s. 25(1)..............................ad. No. 34, 1998

s. 25AA .........................................ad. No. 141, 2010

s. 25A ............................................ad. No. 34, 1998

am. No. 54, 2010

Heading to s. 25B ..........................am. No. 56, 2002

s. 25B ............................................ad. No. 116, 1997 (as am. by No. 3, 1999)

am. No. 56, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

500 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 26 ...............................................am. No. 76, 1993; No. 6, 1996; No. 116, 1997; No. 12, 2000; No. 14,

2001; Nos. 24 and 56, 2002; No. 39, 2003; No. 120, 2004; No. 2, 2006;

No. 76, 2009; Nos. 54 and 141, 2010

Heading to s. 26AA .......................am. No. 56, 2002

s. 26AA .........................................ad. No. 116, 1997

am. No. 56, 2002

Heading to s. 26A..........................rs. No. 14, 2001

s. 26A ............................................ad. No. 6, 1996

am. No. 116, 1997; No. 12, 2000; No. 14, 2001; Nos. 24 and 56, 2002;

No. 39, 2003; No. 120, 2004; No. 2, 2006; No. 76, 2009; Nos. 54 and

141, 2010

s. 26B ............................................ad. No. 120, 2004

am. No. 2, 2006; No. 38, 2009

s. 26BA..........................................ad. No. 2, 2006

s. 26BB..........................................ad. No. 76, 2009

rs. No. 141, 2010

Heading to s. 26BC........................am. No. 141, 2010

s. 26BC..........................................ad. No. 76, 2009

Heading to s. 26BD .......................am. No. 141, 2010

s. 26BD..........................................ad. No. 76, 2009

am. No. 141, 2010

s. 26BE..........................................ad. No. 76, 2009

rep. No. 141, 2010

s. 26C ............................................ad. No. 120, 2004

am. No. 38, 2009

s. 26D ............................................ad. No. 120, 2004

s. 27 ...............................................rs. No. 84, 1991

s. 28 ...............................................am. No. 84, 1991; No. 76, 1993; No. 3, 1999; No. 14, 2001; No. 39,

2003; No. 76, 2009; No. 54, 2010

s. 28A ............................................ad. No. 76, 2009

Note to s. 29 ..................................ad. No. 76, 2009

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 501

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Heading to s. 29A..........................rs. No. 39, 2006

s. 29A ............................................ad. No. 88, 1992

am. No. 6, 1996; No. 39, 2003; No. 39, 2006; No. 38, 2009

Note to s. 29A(1) ...........................ad. No. 180, 2012

s. 29AA .........................................ad. No. 39, 2006

s. 29B ............................................ad. No. 88, 1992

am. No. 6, 1996; No. 111, 2001; No. 39, 2003; No. 39, 2006; No. 38,

2009

Note to s. 29B(3) ...........................ad. No. 180, 2012

Note to s. 29B(4) ...........................ad. No. 180, 2012

s. 29C ............................................ad. No. 39, 2006

ss. 29D–29G..................................ad. No. 76, 2009

s. 30 ...............................................am. No. 88, 1992; No. 6, 1996; No. 34, 1998; No. 56, 2000; Nos. 14 and

111, 2001; No. 39, 2003; No. 39, 2006; No. 76, 2009; No. 141, 2010

s. 30A ............................................ad. No. 6, 1996

am. No. 111, 2001; No. 23, 2002

rep. No. 39, 2003

ad. No. 76, 2009

s. 30B ............................................ad. No. 116, 1997

rep. No. 39, 2003

s. 30C ............................................ad. No. 170, 2000

am. No. 96, 2009

Heading to s. 30D..........................am. No. 96, 2009

s. 30D ............................................ad. No. 170, 2000

am. No. 96, 2009

s. 30E.............................................ad. No. 170, 2000

Division 2A

Div. 2A of Part 3-2 ........................ad. No. 39, 2003

s. 30EA..........................................ad. No. 39, 2003

am. No. 39, 2006; No. 76, 2009; No. 54, 2010

s. 30EB ..........................................ad. No. 39, 2003

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

502 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 30EC ..........................................ad. No. 39, 2003

rs. No. 39, 2006

am. No. 38, 2009

Note to s. 30EC(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 30EC(1)......................ad. No. 180, 2012

Note to s. 30EC(2).........................ad. No. 180, 2012

s. 30ECA .......................................ad. No. 39, 2006

Heading to s. 30ED........................am. No. 76, 2009

s. 30ED..........................................ad. No. 39, 2003

am. No. 76, 2009

Division 3

Heading to s. 30F...........................am. No. 39, 2006

s. 30F.............................................ad. No. 23, 2002

am. No. 39, 2006; No. 38, 2009

Note to s. 30F(4B)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 30F(4B) ......................ad. No. 180, 2012

Note to s. 30F(4C) .........................ad. No. 180, 2012

s. 30FA ..........................................ad. No. 39, 2006

s. 30G ............................................ad. No. 23, 2002

s. 30H ............................................ad. No. 23, 2002

am. No. 38, 2009

s. 31 ...............................................am. No. 84, 1991; No. 76, 1993; No. 6, 1996; No. 34, 1998; Nos. 14 and

111, 2001; No. 39, 2003; No. 39, 2006; No. 38, 2009; Nos. 54 and 141,

2010; No. 77, 2011

Note to s. 31(5A)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 31(5A) ........................ad. No. 180, 2012

Note to s. 31(5B) ...........................ad. No. 180, 2012

s. 31AAA.......................................ad. No. 39, 2006

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 503

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Heading to s. 31A..........................rs. No. 23, 2002

s. 31A ............................................ad. No. 120, 2000

am. No. 39, 2006

s. 31AA .........................................ad. No. 23, 2002

am. No. 39, 2006

s. 31B ............................................ad. No. 120, 2000

am. No. 39, 2006

Heading to s. 31C ..........................am. No. 23, 2002

rs. No. 39, 2006

s. 31C ............................................ad. No. 120, 2000

am. No. 23, 2002

rs. No. 39, 2006

am. No. 38, 2009

s. 31D ............................................ad. No. 120, 2000

am. No. 23, 2002; No. 39, 2006; No. 38, 2009

Note to s. 31D(1) ...........................ad. No. 180, 2012

s. 31E.............................................ad. No. 120, 2000

am. No. 39, 2006; No. 38, 2009

Note to s. 31E(1) ...........................ad. No. 180, 2012

s. 31F.............................................ad. No. 120, 2000

am. No. 39, 2006

Part 3-2A

Part 3-2A .......................................ad. No. 54, 2010

Division 1

s. 32 ...............................................am. Nos. 84 and 204, 1991; No. 76, 1993; No. 6, 1996

rep. No. 24, 2002

ad. No. 54, 2010

s. 32A ............................................ad. No. 54, 2010

ss. 32AA, 32AB.............................ad. No. 54, 2010

Division 2

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

504 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 32B ............................................ad. No. 54, 2010

s. 32BA..........................................ad. No. 54, 2010

Note to s. 32BA(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 32BA(1) .....................ad. No. 180, 2012

Note to s. 32BA(2) ........................ad. No. 180, 2012

s. 32BB..........................................ad. No. 54, 2010

Note to s. 32BB(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 32BB(1)......................ad. No. 180, 2012

Note to s. 32BB(2).........................ad. No. 180, 2012

s. 32BC..........................................ad. No. 54, 2010

Note to s. 32BC(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 32BC(1)......................ad. No. 180, 2012

Note to s. 32BC(2).........................ad. No. 180, 2012

s. 32BD..........................................ad. No. 54, 2010

Note to s. 32BD(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 32BD(1) .....................ad. No. 180, 2012

Note to s. 32BD(2) ........................ad. No. 180, 2012

s. 32BE..........................................ad. No. 54, 2010

s. 32BF ..........................................ad. No. 54, 2010

s. 32BG..........................................ad. No. 54, 2010

s. 32BH..........................................ad. No. 54, 2010

s. 32BI ...........................................ad. No. 54, 2010

s. 32BJ...........................................ad. No. 54, 2010

s. 32BK..........................................ad. No. 54, 2010

Division 3

Subdivision A

s. 32C ............................................ad. No. 54, 2010

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 505

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Subdivision B

s. 32CA..........................................ad. No. 54, 2010

Subdivision C

s. 32CB..........................................ad. No. 54, 2010

Note 1 to s. 32CB(1)......................am. No. 46, 2011

ss. 32CC, 32CD.............................ad. No. 54, 2010

Note to s. 32CD(1) ........................am. No. 46, 2011

s. 32CE..........................................ad. No. 54, 2010

s. 32CF ..........................................ad. No. 54, 2010

s. 32CG..........................................ad. No. 54, 2010

s. 32CH..........................................ad. No. 54, 2010

Note to s. 32CH(1) ........................ad. No. 180, 2012

s. 32CI ...........................................ad. No. 54, 2010

s. 32CJ...........................................ad. No. 54, 2010

Note to s. 32CJ(6)..........................ad. No. 180, 2012

Note to s. 32CJ(7)..........................ad. No. 180, 2012

Subdivision D

ss. 32CK–32CN.............................ad. No. 54, 2010

Subdivision E

s. 32CO..........................................ad. No. 54, 2010

Division 4

Subdivision A

s. 32D ............................................ad. No. 54, 2010

Subdivision B

ss. 32DA–32DC.............................ad. No. 54, 2010

Subdivision C

ss. 32DD–32DM............................ad. No. 54, 2010

Subdivision D

s. 32DN .........................................ad. No. 54, 2010

Subdivision E

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

506 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 32DO .........................................ad. No. 54, 2010

Note to s. 32DO(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 32DO(1) .....................ad. No. 180, 2012

Note to s. 32DO(2) ........................ad. No. 180, 2012

s. 32DP..........................................ad. No. 54, 2010

s. 32DQ .........................................ad. No. 54, 2010

Note to s. 32DQ(1) ........................ad. No. 180, 2012

s. 32DR..........................................ad. No. 54, 2010

Note to s. 32DR(3) ........................ad. No. 180, 2012

Note to s. 32DR(4) ........................ad. No. 180, 2012

Subdivision F

ss. 32DS–32DU.............................ad. No. 54, 2010

Division 5

s. 32E.............................................ad. No. 54, 2010

s. 32EA..........................................ad. No. 54, 2010

s. 32EB ..........................................ad. No. 54, 2010

s. 32EC ..........................................ad. No. 54, 2010

s. 32ED..........................................ad. No. 54, 2010

s. 32EE ..........................................ad. No. 54, 2010

s. 32EF ..........................................ad. No. 54, 2010

Note to s. 32EF(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 32EF(1) ......................ad. No. 180, 2012

Note to s. 32EF(2) .........................ad. No. 180, 2012

s. 32EG..........................................ad. No. 54, 2010

Division 6

s. 32F.............................................ad. No. 54, 2010

ss. 32FA–32FD..............................ad. No. 54, 2010

Division 7

s. 32G ............................................ad. No. 54, 2010

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 507

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

ss. 32GA–32GF.............................ad. No. 54, 2010

Division 8

s. 32H ............................................ad. No. 54, 2010

s. 32HA .........................................ad. No. 54, 2010

s. 32HB..........................................ad. No. 54, 2010

s. 32HC..........................................ad. No. 54, 2010

Note to s. 32HC(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 32HC(1) .....................ad. No. 180, 2012

Note to s. 32HC(2) ........................ad. No. 180, 2012

s. 32HD .........................................ad. No. 54, 2010

s. 32HE..........................................ad. No. 54, 2010

Division 9

Subdivision A

s. 32J..............................................ad. No. 54, 2010

Subdivision B

s. 32JA...........................................ad. No. 54, 2010

s. 32JB...........................................ad. No. 54, 2010

Note to s. 32JB(2)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 32JB(2).......................ad. No. 180, 2012

Note to s. 32JB(3)..........................ad. No. 180, 2012

s. 32JC...........................................ad. No. 54, 2010

s. 32JD...........................................ad. No. 54, 2010

Subdivision C

s. 32JE ...........................................ad. No. 54, 2010

s. 32JF ...........................................ad. No. 54, 2010

s. 32JG...........................................ad. No. 54, 2010

s. 32JH...........................................ad. No. 54, 2010

s. 32JI ............................................ad. No. 54, 2010

Note to s. 32JI(2) ...........................ad. No. 180, 2012

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

508 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 32JJ ............................................ad. No. 54, 2010

s. 32JK...........................................ad. No. 54, 2010

Subdivision D

ss. 32JL, 32JM...............................ad. No. 54, 2010

s. 33 ...............................................rep. No. 24, 2002

Part 3-3

Heading to Part 4 ...........................rep. No. 24, 2002

Heading to Part 3-3........................ad. No. 24, 2002

s. 33A ............................................ad. No. 24, 2002

s. 33B ............................................ad. No. 54, 2010

s. 35 ...............................................am. No. 6, 1996; No. 111, 2001; No. 23, 2002; No. 39, 2003

rs. No. 39, 2006

am. No. 38, 2009; No. 54, 2010

Note to s. 35(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 35(1) ...........................ad. No. 180, 2012

Note to s. 35(2)..............................ad. No. 180, 2012

Note to s. 35(5)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 35(5) ...........................ad. No. 180, 2012

Note to s. 35(7)..............................ad. No. 180, 2012

s. 35A ............................................ad. No. 39, 2006

am. No. 54, 2010

s. 35B ............................................ad. No. 39, 2006

am. No. 38, 2009

s. 35C ............................................ad. No. 39, 2006

s. 36 ...............................................am. No. 76, 2009

Subheads. to s. 37(2), (3) ...............ad. No. 76, 2009

s. 37 ...............................................am. No. 76, 1993; No. 56, 2002; No. 96, 2006; No. 76, 2009

Subhead. to s. 38(1A) ....................ad. No. 76, 2009

Subhead. to s. 38(2) .......................ad. No. 76, 2009

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 509

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Subheads. to s. 38(3), (4) ...............ad. No. 76, 2009

s. 38 ...............................................am. No. 76, 1993; No. 34, 1998; No. 39, 2003; No. 39, 2006; Nos. 38 and

76, 2009

Note 1 to s. 38(2B) ........................am. No. 46, 2011

ss. 38A, 38B ..................................ad. No. 76, 2009

s. 39 ...............................................am. No. 23, 2002; No. 54, 2010

s. 40 ...............................................am. No. 76, 1993; No. 56, 2002; No. 39, 2003; Nos. 38 and 76, 2009;

No. 54, 2010

ss. 40A, 40B ..................................ad. No. 76, 2009

Note 1 to s. 40B(4) ........................am. No. 46, 2011

s. 41 ...............................................am. No. 34, 1998; No. 23, 2002; No. 39, 2003; No. 39, 2006; Nos. 38 and

76, 2009; No. 54, 2010

s. 41AA .........................................ad. No. 38, 2009

s. 41AAA.......................................ad. No. 76, 2009

s. 42 ...............................................

Renumbered s. 41A....................

am. No. 76, 1993

No. 24, 2002

s. 41A ............................................am. No. 76, 2009

Chapter 4

Chapt. 4 .........................................ad. No. 24, 2002

Note to Chapt. 4.............................rs. No. 140, 2007

Part 4-1

Division 1

s. 41B ............................................ad. No. 24, 2002

am. No. 39, 2006

s. 41BA..........................................ad. No. 24, 2002

s. 41BB..........................................ad. No. 24, 2002

am. No. 38, 2009

s. 41BC..........................................ad. No. 24, 2002

am. No. 39, 2006

Note to s. 41BC .............................am. No. 39, 2006

Division 2

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

510 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

ss. 41BD, 41BE .............................ad. No. 24, 2002

am. No. 76, 2009

s. 41BEA .......................................ad. No. 96, 2009

s. 41BF ..........................................ad. No. 24, 2002

s. 41BG..........................................ad. No. 24, 2002

am. No. 76, 2009

ss. 41BH, 41BI ..............................ad. No. 24, 2002

Division 3

s. 41BJ...........................................ad. No. 24, 2002

s. 41BJA ........................................ad. No. 54, 2010

s. 41BK..........................................ad. No. 24, 2002

Part 4-2

s. 41C ............................................ad. No. 24, 2002

Note to s. 41C................................am. No. 39, 2006

Division 1

s. 41CA..........................................ad. No. 24, 2002

Division 2

s. 41CB..........................................ad. No. 24, 2002

am. No. 76, 2009

Note to s. 41CB(1).........................ad. No. 76, 2009

s. 41CC..........................................ad. No. 24, 2002

am. No. 38, 2009; No. 46, 2011

s. 41CD..........................................ad. No. 24, 2002

Part 4-3

s. 41D ............................................ad. No. 24, 2002

Note 1 to s. 41D.............................am. No. 39, 2006

Division 1

ss. 41DA, 41DB.............................ad. No. 24, 2002

Division 2

s. 41DC..........................................ad. No. 24, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 511

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

am. No. 76, 2009

Note to s. 41DC(1) ........................ad. No. 76, 2009

s. 41DD .........................................ad. No. 24, 2002

am. No. 46, 2011

s. 41DE..........................................ad. No. 24, 2002

Part 4-4

s. 41E.............................................ad. No. 24, 2002

Division 1

ss. 41EA, 41EB .............................ad. No. 24, 2002

Note to s. 41EB(2).........................rs. No. 39, 2006

s. 41EC ..........................................ad. No. 24, 2002

am. No. 39, 2003; No. 39, 2006; No. 38, 2009

s. 41ED..........................................ad. No. 24, 2002

am. No. 54, 2010

ss. 41EE, 41EF ..............................ad. No. 24, 2002

s. 41EG..........................................ad. No. 24, 2002

am. No. 38, 2009; No. 141, 2010

s. 41EH..........................................ad. No. 24, 2002

s. 41EI ...........................................ad. No. 24, 2002

rs. No. 39, 2006

am. No. 38, 2009

Note to s. 41EI(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41EI(1) .......................ad. No. 180, 2012

Note to s. 41EI(2) ..........................ad. No. 180, 2012

s. 41EIA.........................................ad. No. 39, 2006

Division 2

Note to heading of Div. 2 ..............rs. No. 39, 2006

s. 41EJ ...........................................ad. No. 24, 2002

am. Nos. 38 and 76, 2009

ss. 41EK, 41EL..............................ad. No. 24, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

512 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Division 3

ss. 41EM–41EQ.............................ad. No. 24, 2002

Division 4

ss. 41ER, 41ES..............................ad. No. 24, 2002

s. 41ET ..........................................ad. No. 24, 2002

am. No. 39, 2003; No. 39, 2006; No. 38, 2009

ss. 41EU–41EW ............................ad. No. 24, 2002

Part 4-5

s. 41F.............................................ad. No. 24, 2002

Division 1

s. 41FA ..........................................ad. No. 24, 2002

Note 2 to s. 41FA ..........................am. No. 39, 2006

s. 41FB ..........................................ad. No. 24, 2002

Subdivision A

s. 41FC ..........................................ad. No. 24, 2002

Note to s. 41FC(2) .........................rs. No. 39, 2006

s. 41FD ..........................................ad. No. 24, 2002

am. No. 39, 2003; No. 96, 2009

s. 41FE ..........................................ad. No. 24, 2002

am. No. 39, 2003

rs. No. 39, 2006

am. No. 38, 2009

Note to s. 41FE(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41FE(1) ......................ad. No. 180, 2012

Note to s. 41FE(2) .........................ad. No. 180, 2012

s. 41FEA........................................ad. No. 39, 2006

Subdivision B

s. 41FF...........................................ad. No. 24, 2002

am. No. 96, 2009

s. 41FG ..........................................ad. No. 24, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 513

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Subdivision C

ss. 41FH–41FJ...............................ad. No. 24, 2002

s. 41FK ..........................................ad. No. 24, 2002

am. No. 141, 2010

Subdivision D

ss. 41FL, 41FM .............................ad. No. 24, 2002

Division 2

Note to heading of Div. 2 ..............rs. No. 39, 2006

s. 41FN ..........................................ad. No. 24, 2002

am. No. 39, 2006; No. 76, 2009

ss. 41FO, 41FP ..............................ad. No. 24, 2002

Part 4-6

Division 1

Subdivision A

s. 41G ............................................ad. No. 24, 2002

ss. 41GA–41GE.............................ad. No. 24, 2002

Subdivision B

ss. 41GF–41GH.............................ad. No. 24, 2002

Subdivision C

s. 41GI...........................................ad. No. 24, 2002

Note to s. 41GI ..............................am. No. 39, 2006

s. 41GJ...........................................ad. No. 24, 2002

Division 2

s. 41GK .........................................ad. No. 24, 2002

s. 41GL..........................................ad. No. 24, 2002

am. No. 39, 2003

s. 41GM.........................................ad. No. 24, 2002

s. 41GN .........................................ad. No. 24, 2002

am. No. 39, 2006

ss. 41GO–41GQ ............................ad. No. 24, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

514 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Part 4-6A

Part 4-6A .......................................ad. No. 38, 2009

ss. 41GR–41GW............................ad. No. 38, 2009

s. 41GX .........................................ad. No. 38, 2009

rep. No. 54, 2010

s. 41GY .........................................ad. No. 38, 2009

Part 4-7

Heading to Part 4-7........................rs. No. 38, 2009

s. 41H ............................................ad. No. 24, 2002

am. No. 38, 2009; No. 141, 2010

s. 41HA .........................................ad. No. 24, 2002

Notes to s. 41HA(1), (2) ................am. No. 39, 2006

s. 41HB..........................................ad. No. 24, 2002

Note to s. 41HB(2) ........................am. No. 39, 2006

Note to s. 41HB(7) ........................am. No. 39, 2006

s. 41HC..........................................ad. No. 24, 2002

am. No. 54, 2010

s. 41HD .........................................ad. No. 141, 2010

Part 4-8

s. 41J..............................................ad. No. 24, 2002

am. No. 38, 2009

Note to s. 41J.................................am. No. 39, 2006

Division 1

s. 41JA...........................................ad. No. 24, 2002

am. No. 39, 2003; Nos. 38 and 76, 2009

s. 41JB...........................................ad. No. 24, 2002

am. No. 39, 2006; No. 38, 2009

Note to s. 41JB(4)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41JB(4).......................ad. No. 180, 2012

Note to s. 41JB(5)..........................ad. No. 180, 2012

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 515

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 41JBA ........................................ad. No. 39, 2006

s. 41JC...........................................ad. No. 24, 2002

am. No. 39, 2006

Division 2

s. 41JCA ........................................ad. No. 38, 2009

ss. 41JD–41JF................................ad. No. 24, 2002

am. No. 39, 2006

s. 41JFA.........................................ad. No. 141, 2010

s. 41JG...........................................ad. No. 24, 2002

rs. No. 39, 2006

am. No. 38, 2009; No. 141, 2010

Note to s. 41JG..............................am. No. 38, 2009; No. 141, 2010

s. 41JH...........................................ad. No. 24, 2002

am. No. 39, 2006; No. 38, 2009; No. 141, 2010

Note to s. 41JH..............................ad. No. 180, 2012

s. 41JI ............................................ad. No. 24, 2002

am. No. 39, 2006; No. 38, 2009; No. 141, 2010

Note to s. 41JI(1) ...........................ad. No. 180, 2012

s. 41JJ ............................................ad. No. 24, 2002

am. No. 39, 2006; No. 38, 2009; No. 141, 2010

Part 4-9

s. 41K ............................................ad. No. 24, 2002

s. 41KA .........................................ad. No. 24, 2002

am. No. 38, 2009; Nos. 54, and 141, 2010

s. 41KB..........................................ad. No. 24, 2002

s. 41KC..........................................ad. No. 24, 2002

rs. No. 39, 2006

am. No. 38, 2009

Note to s. 41KC(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41KC(1) .....................ad. No. 180, 2012

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

516 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Note to s. 41KC(2) ........................ad. No. 180, 2012

s. 41KCA.......................................ad. No. 39, 2006

s. 41KD .........................................ad. No. 24, 2002

Part 4-10

s. 41L.............................................ad. No. 24, 2002

ss. 41LA–41LE..............................ad. No. 24, 2002

Part 4-11

Heading to Part 4-11......................rs. No. 39, 2006

s. 41M............................................ad. No. 24, 2002

am. No. 39, 2006; No. 38, 2009

Note to s. 41M...............................am. No. 39, 2006

Division 1

s. 41MA.........................................ad. No. 24, 2002

am. No. 39, 2003

rs. No. 39, 2006

am. No. 38, 2009

Note to s. 41MA(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41MA(1).....................ad. No. 180, 2012

Note to s. 41MA(2)........................ad. No. 180, 2012

Note to s. 41MA(5)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41MA(5).....................ad. No. 180, 2012

Note to s. 41MA(6)........................ad. No. 180, 2012

Note to s. 41MA(9)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41MA(9).....................ad. No. 180, 2012

Note to s. 41MA(10)......................ad. No. 180, 2012

s. 41MAA......................................ad. No. 39, 2006

am. No. 38, 2009

s. 41MB.........................................ad. No. 24, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 517

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

am. No. 39, 2006

Note to s. 41MB(2)........................rep. No. 39, 2006

Notes 1, 2 to s. 41MB(2) ...............ad. No. 39, 2006

s. 41MC.........................................ad. No. 24, 2002

rs. No. 39, 2006

am. No. 38, 2009

Note to s. 41MC(2)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41MC(2).....................ad. No. 180, 2012

Note to s. 41MC(3)........................ad. No. 180, 2012

s. 41MCA ......................................ad. No. 39, 2006

s. 41MD.........................................ad. No. 24, 2002

am. No. 39, 2006

Division 2

s. 41ME .........................................ad. No. 24, 2002

am. No. 39, 2003

rs. No. 39, 2006

am. No. 38, 2009

Note to s. 41ME(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41ME(1) .....................ad. No. 180, 2012

Note to s. 41ME(2) ........................ad. No. 180, 2012

Note to s. 41ME(5)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41ME(5) .....................ad. No. 180, 2012

Note to s. 41ME(6) ........................ad. No. 180, 2012

s. 41MEA ......................................ad. No. 39, 2006

am. No. 38, 2009

s. 41MF .........................................ad. No. 24, 2002

am. No. 39, 2003

rs. No. 39, 2006

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

518 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

am. No. 38, 2009

Note to s. 41MF(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41MF(1) .....................ad. No. 180, 2012

Note to s. 41MF(3)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41MF(3) .....................ad. No. 180, 2012

s. 41MG.........................................ad. No. 24, 2002

am. No. 39, 2006

Note to s. 41MG(2)........................rep. No. 39, 2006

Notes 1, 2 to s. 41MG(2) ...............ad. No. 39, 2006

Heading to s. 41MH ......................rs. No. 39, 2006

s. 41MH.........................................ad. No. 24, 2002

am. No. 39, 2003; No. 38, 2009

Note to s. 41MH ............................ad. No. 180, 2012

s. 41MHA......................................ad. No. 39, 2006

Division 3

s. 41MI ..........................................ad. No. 24, 2002

am. No. 39, 2003

rs. No. 39, 2006

am. No. 38, 2009; No. 141, 2010

Note to s. 41MI(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41MI(1) ......................ad. No. 180, 2012

Note to s. 41MI(2) .........................ad. No. 180, 2012

s. 41MIA .......................................ad. No. 39, 2006

s. 41MIB........................................ad. No. 39, 2006

am. No. 38, 2009; No. 141, 2010

s. 41MJ ..........................................ad. No. 24, 2002

am. No. 39, 2006

s. 41MK.........................................ad. No. 24, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 519

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

am. No. 38, 2009; No. 141, 2010

Heading to s. 41ML.......................rs. No. 39, 2006; No. 96, 2009

s. 41ML .........................................ad. No. 24, 2002

am. No. 39, 2006; No. 38, 2009

rs. No. 96, 2009

s. 41MLA ......................................ad. No. 39, 2006

am. No. 141, 2010

s. 41MM ........................................ad. No. 24, 2002

am. No. 38, 2009

s. 41MN.........................................ad. No. 24, 2002

rs. No. 39, 2006

am. No. 38, 2009; No. 141, 2010

Note to s. 41MN(1)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 41MN(1).....................ad. No. 180, 2012

Note to s. 41MN(2)........................ad. No. 180, 2012

s. 41MNA......................................ad. No. 39, 2006

Division 3A

Div. 3A of Part 4-11 ......................ad. No. 38, 2009

s. 41MNB ......................................ad. No. 38, 2009

Note to s. 41MNB(1).....................ad. No. 180, 2012

s. 41MNC ......................................ad. No. 38, 2009

s. 41MND......................................ad. No. 38, 2009

Division 4

Heading to Div. 4 of ......................

Part 4-11

rs. No. 39, 2006

s. 41MO.........................................ad. No. 24, 2002

rs. No. 39, 2006

am. No. 38, 2009

Heading to s. 41MP .......................rs. No. 39, 2006

s. 41MP .........................................ad. No. 24, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

520 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

am. No. 39, 2006; No. 38, 2009

Note to s. 41MP(1) ........................ad. No. 180, 2012

ss. 41MPA, 41MPB.......................ad. No. 39, 2006

s. 41MQ.........................................ad. No. 24, 2002

am. No. 39, 2006; No. 38, 2009

Note to s. 41MQ(3)........................ad. No. 180, 2012

Note to s. 41MQ(4)........................ad. No. 180, 2012

s. 41MR.........................................ad. No. 39, 2006

Chapter 5

Heading to Part 4A ........................rep. No. 24, 2002

Heading to Chapt. 5.......................ad. No. 24, 2002

Part 4A ..........................................ad. No. 3, 1999

Part 5-1

Heading to Part 5-1........................ad. No. 24, 2002

rs. No. 39, 2003

Division 1

Heading to Div. 1 of ......................

Part 5-1

ad. No. 39, 2003

s. 42AA .........................................ad. No. 39, 2003

am. No. 76, 2009

s. 42AB..........................................ad. No. 39, 2003

s. 42AC..........................................ad. No. 39, 2003

am. No. 38, 2009

s. 42A ............................................ad. No. 3, 1999

rep. No. 39, 2003

s. 42B ............................................ad. No. 3, 1999

am. No. 39, 2003; No. 38, 2009

s. 42BAA.......................................ad. No. 76, 2009

Division 2

Heading to Div. 2 of ......................

Part 5-1

ad. No. 39, 2003

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 521

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 42BA..........................................ad. No. 39, 2003

s. 42C ............................................ad. No. 3, 1999

rs. No. 39, 2003

am. No. 39, 2006

Notes to s. 42C(1), (2) ...................ad. No. 39, 2006

Note to s. 42C(4) ...........................ad. No. 39, 2006

Note to s. 42C(6) ...........................ad. No. 39, 2006

s. 42D ............................................ad. No. 3, 1999

rep. No. 39, 2003

Division 3

Div. 3 of Part 5-1...........................ad. No. 39, 2003

s. 42DA .........................................ad. No. 39, 2003

rs. No. 38, 2009

s. 42DB..........................................ad. No. 39, 2003

s. 42DC..........................................ad. No. 39, 2003

rep. No. 38, 2009

s. 42DD .........................................ad. No. 39, 2003

am. Nos. 38 and 76, 2009

Note to s. 42DD(1) ........................ad. No. 38, 2009

s. 42DE..........................................ad. No. 39, 2003

s. 42DF..........................................ad. No. 39, 2003

am. No. 76, 2009

ss. 42DG–42DJ..............................ad. No. 39, 2003

s. 42DK .........................................ad. No. 39, 2003

am. No. 8, 2010

Division 3A

Heading to Div. 3A of ...................

Part 5-1

ad. No. 38, 2009

ss. 42DKA, 42DKB.......................ad. No. 38, 2009

s. 42DL..........................................ad. No. 39, 2003

am. No. 38, 2009; No. 54, 2010

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

522 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 42DM.........................................ad. No. 39, 2003

Division 4

Div. 4 of Part 5-1...........................ad. No. 39, 2003

ss. 42DN–42DP.............................ad. No. 39, 2003

Part 5-2

Heading to Part 4B ........................rep. No. 24, 2002

Heading to Part 5-2........................ad. No. 24, 2002

Part 4B...........................................ad. No. 56, 2000

s. 42E.............................................ad. No. 56, 2000

am. No. 39, 2003; No. 39, 2006; No. 38, 2009

Note to s. 42E(1) ...........................ad. No. 180, 2012

ss. 42EA, 42EB .............................ad. No. 39, 2006

s. 42F.............................................ad. No. 56, 2000

Part 5-3

Heading to Part 4C ........................rep. No. 24, 2002

Heading to Part 5-3........................ad. No. 24, 2002

Part 4C...........................................ad. No. 120, 2000

s. 42T.............................................ad. No. 120, 2000

am. No. 39, 2006; No. 38, 2009

Note to s. 42T(1) ...........................ad. No. 180, 2012

Note to s. 42T(2) ...........................ad. No. 180, 2012

s. 42U ............................................ad. No. 120, 2000

s. 42V ............................................ad. No. 120, 2000

am. No. 24, 2002; No. 39, 2006; No. 38, 2009; No. 54, 2010

Note to s. 42V(6)

Renumbered Note 1 ...................No. 180, 2012

Note 2 to s. 42V(6) ........................ad. No. 180, 2012

Note to s. 42V(6A) ........................ad. No. 180, 2012

ss. 42VA, 42VB.............................ad. No. 39, 2006

s. 42W ...........................................ad. No. 120, 2000

am. No. 39, 2006; No. 38, 2009

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 523

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Note to s. 42W(1) ..........................ad. No. 180, 2012

Note to s. 42W(2) ..........................ad. No. 180, 2012

s. 42X ............................................ad. No. 120, 2000

Chapter 5A

Chapt. 5A ......................................ad. No. 39, 2006

Part 5A-1

Division 1

s. 42Y ............................................ad. No. 39, 2006

ss. 42YA–42YD ............................ad. No. 39, 2006

s. 42YE..........................................ad. No. 39, 2006

am. No. 38, 2009

Division 2

ss. 42YF–42YI...............................ad. No. 39, 2006

Part 5A-2

ss. 42YJ, 42YK..............................ad. No. 39, 2006

Part 5A-3

s. 42YL..........................................ad. No. 39, 2006

am. No. 8, 2010

Chapter 6

Heading to Part 5 ...........................rep. No. 24, 2002

Heading to Chapt. 6.......................ad. No. 24, 2002

Part 6-1

Heading to Part 6-1........................ad. No. 24, 2002

s. 43 ...............................................am. No. 24, 2002

s. 44 ...............................................am. No. 84, 1991; No. 24, 2002

rs. No. 96, 2008

s. 44A ............................................ad. No. 96, 2008

s. 44B ............................................ad. No. 54, 2010

s. 45 ...............................................rs. No. 152, 1997

am. No. 24, 2002

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

524 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

rs. No. 8, 2005

Part 6-2

Heading to Part 6 ...........................rep. No. 6, 1996

Heading to Part 5A ........................ad. No. 6, 1996

rep. No. 24, 2002

Heading to Part 6-2........................ad. No. 24, 2002

s. 45A ............................................ad. No. 6, 1996

am. No. 39, 2006

s. 46 ...............................................rs. No. 6, 1996

s. 46A ............................................ad. No. 6, 1996

am. Nos. 23 and 24, 2002; Nos. 38 and 76, 2009; Nos. 54 and 141, 2010

s. 46B ............................................ad. No. 6, 1996

Heading to s. 47.............................am. No. 39, 2006

s. 47 ...............................................am. No. 76, 1993

rs. No. 6, 1996

am. No. 39, 2006

s. 48 ...............................................am. No. 6, 1996; No. 111, 2001; Nos. 38 and 76, 2009

ss. 48A, 48B ..................................ad. No. 6, 1996

s. 48C ............................................ad. No. 6, 1996

am. No. 39, 2006

s. 48D ............................................ad. No. 6, 1996

s. 48E.............................................ad. No. 6, 1996

am. No. 39, 2006

ss. 48F–48H...................................ad. No. 6, 1996

s. 48J..............................................ad. No. 6, 1996

am. No. 39, 2006

s. 49 ...............................................am. No. 6, 1996

Heading to s. 50.............................am. No. 39, 2006

s. 50 ...............................................am. No. 6, 1996; No. 39, 2006

Heading to s. 51.............................am. No. 39, 2006

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 525

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 51 ...............................................am. No. 6, 1996

s. 51A ............................................ad. No. 76, 1993

s. 51B ............................................ad. No. 6, 1996

am. No. 38, 2009

s. 52 ...............................................am. No. 6, 1996; No. 111, 2001; No. 38, 2009

Part 6-3

Heading to Part 5B ........................rep. No. 24, 2002

Heading to Part 6-3........................ad. No. 24, 2002

rs. No. 96, 2009

Part 5B...........................................ad. No. 3, 1999

s. 52AA .........................................ad. No. 96, 2009

s. 52A ............................................ad. No. 3, 1999

am. No. 96, 2009

ss. 52B, 52C ..................................ad. No. 3, 1999

rs. No. 96, 2009

s. 52CA..........................................ad. No. 96, 2009

s. 52D ............................................ad. No. 3, 1999

am. No. 9, 2008; No. 96, 2009

s. 52E.............................................ad. No. 3, 1999

rs. No. 96, 2009

s. 52EAA.......................................ad. No. 96, 2009

ss. 52EA, 52EB .............................ad. No. 9, 2008

s. 52EC ..........................................ad. No. 96, 2009

Heading to Part 5C ........................rep. No. 24, 2002

Heading to Part 6-4........................ad. No. 24, 2002

rep. No. 76, 2009

Part 5C...........................................ad. No. 3, 1999

Part 6-4..........................................rep. No. 76, 2009

ss. 52F, 52G...................................ad. No. 3, 1999

rep. No. 76, 2009

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

526 Therapeutic Goods Act 1989

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

Chapter 7

Heading to Part 6 ...........................ad. No. 6, 1996

rep. No. 24, 2002

Heading to Chapt. 7.......................ad. No. 24, 2002

s. 53 ...............................................rs. No. 24, 2002

am. No. 54, 2010

s. 53A ............................................ad. No. 39, 2006

am. No. 54, 2010

Heading to s. 54.............................rs. No. 6, 1996; No. 39, 2006

s. 54 ...............................................am. No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 24, 2002; No. 39,

2006

s. 54AA .........................................ad. No. 3, 1999

am. No. 111, 2001; No. 39, 2003; No. 73, 2008

Heading to s. 54AB .......................rs. No. 39, 2006

s. 54AB..........................................ad. No. 39, 2003

am. No. 39, 2006; No. 38, 2009

Note to s. 54AB(1) ........................ad. No. 180, 2012

s. 54A ............................................ad. No. 6, 1996

Heading to s. 54B ..........................rs. No. 180, 2012

s. 54B ............................................ad. No. 39, 2006

am. No. 180, 2012

s. 54BA..........................................ad. No. 180, 2012

s. 54C ............................................ad. No. 39, 2006

s. 55 ...............................................am. No. 6, 1996; No. 39, 2006

s. 56 ...............................................am. No. 24, 2002; Nos. 38 and 76, 2009

s. 56A ............................................ad. No. 6, 1996

am. No. 24, 2002; No. 39, 2006; Nos. 38 and 76, 2009; Nos. 54 and 141,

2010

s. 57 ...............................................am. Nos. 84 and 204, 1991; No. 88, 1992; No. 6, 1996; No. 146, 1999;

Nos. 23 and 24, 2002; No. 5, 2006; Nos. 38 and 96, 2009; Nos. 54 and

141, 2010

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 2—Amendment history

Therapeutic Goods Act 1989 527

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted

exp. = expired or ceased to have effect

Provision affected How affected

s. 58 ...............................................am. No. 76, 1993; No. 76, 2009

s. 59 ...............................................am. No. 54, 2010

s. 60 ...............................................am. No. 6, 1996; No. 24, 2002; No. 39, 2003; No. 39, 2006; No. 76,

2009; Nos. 54 and 141, 2010

s. 60A ............................................ad. No. 6, 1996

am. No. 24, 2002; No. 54, 2010

s. 61 ...............................................am. No. 84, 1991; No. 88, 1992; No. 76, 1993; No. 116, 1997; No. 34,

1998; Nos. 12 and 120, 2000; No. 24, 2002; No. 39, 2006; Nos. 38 and

76, 2009; No. 54, 2010

s. 61A ............................................ad. No. 54, 2010

s. 62 ...............................................rep. No. 136, 2012

s. 63 ...............................................am. No. 204, 1991; No. 76, 1993; No. 6, 1996; No. 34, 1998; No. 24,

2002; No. 54, 2010

Chapter 8

Heading to Part 7 ...........................rep. No. 24, 2002

Heading to Chapt. 8.......................ad. No. 24, 2002

s. 64 ...............................................rep. No. 136, 2012

s. 65 ...............................................rep. No. 136, 2012

s. 66 ...............................................am. No. 76, 1993

Heading to s. 68.............................am. No. 24, 2002

s. 69 ...............................................am. No. 24, 2002; No. 136, 2012

Schedule ........................................am. No. 141, 1990

rep. No. 136, 2012

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

528 Therapeutic Goods Act 1989

Endnote 3—Application, saving and transitional provisions

This endnote sets out application, saving and transitional provisions for

amendments of the Therapeutic Goods Act 1989.

Application, saving and transitional provisions prior to 30 May 2000 are not

included in this endnote.

Therapeutic Goods Amendment Act (No. 2) 2000 (No. 56, 2000)

Schedule 1

5 Application

The amendment of section 30 of the Therapeutic Goods Act 1989

by this Schedule applies to directions given, and requirements

made, of persons after the commencement of the amendment.

Therapeutic Goods Amendment Act (No. 3) 2000 (No. 120, 2000)

Schedule 1

4 Saving

(1) Regulations in force for the purposes of subsection 18(1) of the

Therapeutic Goods Act 1989 immediately before the commencement of

the amendment of that subsection made by this Schedule have effect,

after that commencement, as if they had been made for the purposes of

that subsection after that commencement.

(2) Subitem (1) does not prevent the amendment or repeal of the

regulations.

6 Application

Conditions specified in regulations made for the purposes of

subsection 19(1A) of the Therapeutic Goods Act 1989 apply to an

approval for the purpose mentioned in paragraph 19(1)(b) of that Act

granted before or after the commencement of subsection 19(1A).

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 529

8 Application

Conditions specified in regulations made for the purposes of

subsection 19(4A) of the Therapeutic Goods Act 1989 apply to an

approval for the purpose mentioned in paragraph 19(1)(b) of that Act

granted before or after the commencement of subsection 19(4A).

10 Application

Subsection 19(5B) of the Therapeutic Goods Act 1989 applies to an

authority given under subsection 19(5) of that Act before or after the

commencement of subsection 19(5B).

17 Application

(1) Subsections 31B(1) and (2) of the Therapeutic Goods Act 1989 apply to

an approval granted under subsection 19(1) of that Act before or after

the commencement of section 31B of that Act.

(2) Subsection 31B(3) of the Therapeutic Goods Act 1989 applies to an

authority given under subsection 19(5) of that Act before or after the

commencement of section 31B of that Act.

Therapeutic Goods Amendment Act 2001 (No. 14, 2001)

Schedule 1

36 Application of amendments

(1) The amendments made by this Schedule do not apply, and the

Therapeutic Goods Act 1989 as in force immediately before the

commencement of this Schedule continues to apply, in relation to any

application made under that Act, before that commencement, for listing

of therapeutic goods.

(2) However, the amendment made by item 5 of this Schedule applies, after

that commencement, to therapeutic goods that were listed before that

commencement.

(3) The amendment made by item 31 of this Schedule applies, after that

commencement, to medicines listed under section 26A before that

commencement.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

530 Therapeutic Goods Act 1989

Australia New Zealand Food Authority Amendment Act 2001 (No. 81,

2001)

2(6) In this section:

Australia New Zealand Joint Food Standards Agreement means

the Agreement between the Government of Australia and the

Government of New Zealand Establishing a System for the

Development of Joint Food Standards, signed at Wellington on

5 December 1995.

Health and Aged Care Legislation Amendment (Application of Criminal

Code) Act 2001 (No. 111, 2001)

4 Application of amendments

(1) Each amendment made by this Act applies to acts and omissions

that take place after the amendment commences.

(2) For the purposes of this section, if an act or omission is alleged to

have taken place between 2 dates, one before and one on or after

the day on which a particular amendment commences, the act or

omission is alleged to have taken place before the amendment

commences.

Therapeutic Goods Amendment (Medical Devices) Act 2002 (No. 24, 2002)

Schedule 1

38 Transitional for publication of list of goods on Register

The first list published under section 9E of the Therapeutic Goods Act

1989 after the commencement of this Schedule must be published

within 12 months after the last list published under section 33 of the

Therapeutic Goods Act 1989.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 531

46 Saving of existing registrations and listings

(1) Despite the repeal of section 17 of the Therapeutic Goods Act 1989 by

item 45, any therapeutic goods that, immediately before the

commencement of this Schedule, were included in the Register are

taken to be included in the Register after that commencement.

(2) Despite the repeal of subsection 17(5) of the Therapeutic Goods Act

1989, any notices that were in force immediately before the

commencement of this Schedule, are taken to have been made under

section 9A after that commencement.

55 Saving of existing requests for inspection or variation of the Register

(1) A request for a copy of an entry in the Register under section 32 of the

Therapeutic Goods Act 1989:

(a) that was made before the commencement of this Schedule;

and

(b) that was not dealt with before that commencement;

is taken, after that commencement, to be a request made under

section 9C of the Therapeutic Goods Act 1989 as in force after that

commencement.

(2) A request for a variation of an entry in the Register under section 32 of

the Therapeutic Goods Act 1989:

(a) that was made before the commencement of this Schedule;

and

(b) that was not dealt with before that commencement;

is taken, after that commencement, to be a request made under

section 9D of the Therapeutic Goods Act 1989 as in force after that

commencement.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

532 Therapeutic Goods Act 1989

Therapeutic Goods and Other Legislation Amendment Act 2002 (No. 56,

2002)

Schedule 3

20 Application

(1) The amendment made by item 12 applies in relation to applications

made on or after the commencement of that item.

(2) The amendment made by item 18 applies in relation to applications for

licences made on or after the commencement of that item.

(3) Paragraph 40(4)(a) of the Therapeutic Goods Act 1989 as amended by

this Schedule applies in relation to a request made under that paragraph

on or after the commencement of this item, even if the licence to which

the request relates was granted before that commencement.

21 Transitional

(1) An approval of a body as an approved conformity assessment body that

was in force under the Therapeutic Goods Act 1989 immediately before

the commencement time has effect after the commencement time as if it

were an approval of the body by the Secretary in writing for the

purposes of the definition of EC/EFTA attestation of conformity in

subsection 3(1) of the Therapeutic Goods Act 1989 as in force after the

commencement time.

(2) In subitem (1):

commencement time means the time at which this item commences.

Therapeutic Goods Amendment Act (No. 1) 2003 (No. 39, 2003)

Schedule 1

41 Saving provisions

(1) The repeal of subsections 30(6) and (7) of the Therapeutic Goods Act

1989 does not affect the application, after the commencement of this

item, of paragraph 30(6)(b) and subsection 30(7) of that Act in relation

to a requirement imposed under paragraph 30(6)(a) of that Act before

that commencement.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 533

(2) The repeal of section 30A of the Therapeutic Goods Act 1989 does not

affect the application, after the commencement of this item, of

subsections 30A(3) and (4) of that Act in relation to a requirement

imposed under subsection 30A(2) of that Act before that

commencement.

(3) The repeal of section 30B of the Therapeutic Goods Act 1989 does not

affect the application, after the commencement of this item, of

subsections 30B(3), (4) and (5) of that Act in relation to a requirement

imposed under subsection 30B(2) of that Act before that

commencement.

55 Saving provision

The repeal and substitution of subsection 40(1) of the Therapeutic

Goods Act 1989 does not affect the application, after the

commencement of this item, of any condition that:

(a) was imposed on a licence under that subsection; and

(b) was in force immediately before that commencement.

60 Application provision

Subsection 40(4) of the Therapeutic Goods Act 1989 as amended by

this Act, and subsection 40(5) of that Act, apply to any licence in force

after the commencement of this item, whether or not the licence was

granted after that commencement.

US Free Trade Agreement Implementation Act 2004 (No. 120, 2004)

Schedule 7

7 Application of amendments

(1) The amendments made by this Schedule apply to applications for

registration or listing under section 23 of the Therapeutic Goods Act

1989 made on or after the day on which this Schedule commences.

(2) The amendments made by item 6 apply to legal proceedings

commenced on or after the day on which this Schedule commences.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

534 Therapeutic Goods Act 1989

Financial Framework Legislation Amendment Act 2005 (No. 8, 2005)

4 Saving of matters in Part 2 of Schedule 1

(1) If:

(a) a decision or action is taken or another thing is made, given

or done; and

(b) the thing is taken, made, given or done under a provision of a

Part 2 Act that had effect immediately before the

commencement of this Act;

then the thing has the corresponding effect, for the purposes of the

Part 2 Act as amended by this Act, as if it had been taken, made,

given or done under the Part 2 Act as so amended.

(2) In this section:

Part 2 Act means an Act that is amended by an item in Part 2 of

Schedule 1.

Schedule 1

496 Saving provision—Finance Minister’s determinations

If a determination under subsection 20(1) of the Financial Management

and Accountability Act 1997 is in force immediately before the

commencement of this item, the determination continues in force as if it

were made under subsection 20(1) of that Act as amended by this Act.

Therapeutic Goods Amendment Act (No. 2) 2006 (No. 2, 2006)

Schedule 1

15 Application

The amendments made by this Schedule apply to applications for

registration or listing of therapeutic goods that are made on or after the

day on which this Schedule commences.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 535

Therapeutic Goods Amendment (Repeal of Ministerial responsibility for

approval of RU486) Act 2006 (No. 5, 2006)

3 Purpose

The purpose of this Act is to remove the responsibility for approval

of RU486 from the Minister and to provide responsibility for

approval of RU486 to the Therapeutic Goods Administration.

Therapeutic Goods Legislation Amendment (Annual Charges) Act 2008

(No. 96, 2008)

Schedule 1

3 Application

(1) The amendment made by item 1 applies in relation to the financial year

beginning on 1 July 2009 and all later financial years (regardless of

whether the registration, listing or inclusion in the Register of the

therapeutic goods, or whether the licence, commenced before, on or

after 1 July 2009).

(2) The amendment made by item 2 applies for the purposes of working out

whether a person is exempt from liability to pay annual registration

charge, annual listing charge or annual charge for inclusion in the

financial years.

Therapeutic Goods Amendment (Medical Devices and Other Measures)

Act 2009 (No. 38, 2009)

Schedule 2

4 Application

(1) The amendment made by item 1 applies in relation to an exemption

made on or after the commencement of that item.

(2) The amendment made by item 2 applies in relation to a revocation or

variation made on or after the commencement of that item (whether the

exemption was made before, on or after that commencement).

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

536 Therapeutic Goods Act 1989

Schedule 3

23 Application and transitional

(1) The amendments of section 38 of the Therapeutic Goods Act 1989

made by this Schedule apply in relation to applications for licences

made on or after the commencement of this item.

(2) The amendments of sections 40 and 41 of the Therapeutic Goods Act

1989 made by this Schedule apply in relation to licences granted before,

on or after the commencement of this item.

(3) The amendments of section 41EC of the Therapeutic Goods Act 1989

made by this Schedule apply in relation to applications for conformity

assessment certificates made on or after the commencement of this

item.

(4) The amendment of section 41EG of the Therapeutic Goods Act 1989

made by this Schedule applies in relation to notices given on or after the

commencement of this item.

(5) The amendment of section 41EJ of the Therapeutic Goods Act 1989

made by this Schedule applies in relation to conformity assessment

certificates issued before, on or after the commencement of this item.

(6) The amendments of section 41ET of the Therapeutic Goods Act 1989

made by this Schedule apply in relation to conformity assessment

certificates issued before, on or after the commencement of this item.

(7) Paragraph 41ET(1)(c) of the Therapeutic Goods Act 1989, as in force

immediately before the commencement of this item, continues to apply

on and after that commencement in relation to a notice given before that

commencement.

(8) Subsection 41JA(1A) of the Therapeutic Goods Act 1989 applies in

relation to applications for conformity assessment certificates made on

or after the commencement of this item.

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 537

(9) Subsection 41JA(1C) of the Therapeutic Goods Act 1989 applies in

relation to conformity assessment certificates issued before, on or after

the commencement of this item.

Schedule 4

20 Application and transitional

(1) If:

(a) immediately before the commencement of this item,

therapeutic goods were registered goods or listed goods; and

(b) at a particular time within the period of 12 months beginning

on the day on which this item commences:

(i) a standard referred to in paragraph (c) or (d) of the

definition of standard in subsection 3(1) of the

Therapeutic Goods Act 1989 (as amended by this Act)

would, apart from this subitem, apply to the goods; and

(ii) the goods do not conform with that standard;

then that standard is taken not to apply to the goods at that time.

(2) To avoid doubt, paragraph (a) of the definition of standard in

subsection 3(1) of the Therapeutic Goods Act 1989 (as amended by this

Act) applies in relation to orders made under section 10 of the

Therapeutic Goods Act 1989 before, on or after the commencement of

this item.

(3) An order in force under paragraph 13(7)(c) of the Therapeutic Goods

Act 1989 immediately before the commencement of this item has effect,

on and after that commencement, as if it were an order in force under

subsection 13(5) of that Act.

Schedule 5

3 Application

The amendment made by item 2 applies in relation to information held

by the Department on or after the commencement of this item

(regardless of whether the information came into existence before, on or

after that commencement).

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

538 Therapeutic Goods Act 1989

Schedule 6

12 Saving and transitional

(1) A notice in force under section 42DC of the Therapeutic Goods Act

1989 immediately before the commencement of this item has effect, on

and after that commencement, as if it were a notice given and in force

under section 42DKB of that Act.

(2) Regulations in force for the purposes of subsection 42DD(1) of the

Therapeutic Goods Act 1989 immediately before the commencement of

this item continue in force on and after that commencement as if they

were regulations in force for the purposes of section 42DD of that Act.

Therapeutic Goods Amendment (2009 Measures No. 1) Act 2009 (No. 76,

2009)

Schedule 1

7 Application

The amendment made by item 2 applies in relation to therapeutic goods

included in the Register before, on or after the commencement of that

item.

Schedule 2

25 Application and transitional—amendments made by this Schedule

(1) The amendments made by items 4 to 7 apply in relation to applications

for licences made on or after the commencement of those items.

(2) The amendments made by items 8 to 11 apply in relation to applications

for licences:

(a) made on or after the commencement of those items; and

(b) made before the commencement of those items that have not

been decided by the Secretary before that commencement.

(3) In relation to an application covered by paragraph (2)(b) of this item,

paragraph 38(1)(a) of the Therapeutic Goods Act 1989 applies on and

after the commencement of this item as if the application was in respect

ComLaw Authoritative Act C2013C00132

Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 539

of the one or more manufacturing sites constituted by the manufacturing

premises the subject of the application.

(4) The amendments made by items 13 to 22 apply in relation to licences

granted before, on or after the commencement of those items.

26 Transitional—existing licences

(1) This item applies to a licence that:

(a) was in force under Part 3-3 of the Therapeutic Goods Act

1989 immediately before the commencement of this item; or

(b) was suspended under that Part immediately before that

commencement.

(2) The Therapeutic Goods Act 1989 applies in relation to the licence on

and after that commencement as if the licence covered the one or more

manufacturing sites constituted by the manufacturing premises to which

the licence related immediately before that commencement.

(3) Subitem (2) is subject to section 38B of the Therapeutic Goods Act

1989 (about splitting multi-site licences).

(4) If section 38B of the Therapeutic Goods Act 1989 does not apply in

relation to the licence, that Act applies in relation to the licence on and

after the commencement of this item as if:

(a) the licence authorised the holder of the licence, at the

manufacturing site constituted by the manufacturing premises

to which the licence related immediately before that

commencement, to carry out the steps in the manufacture of

therapeutic goods that the licence allowed the holder to carry

out immediately before that commencement; and

(b) that authorisation were an authorisation referred to in

subsection 38(2B) of that Act.

(5) Subitem (4) does not prevent the variation of that authorisation under

section 40A or 40B of the Therapeutic Goods Act 1989.

Note: A contravention of that authorisation may lead to the licence being revoked or suspended: see paragraph 41(1)(ea) of the Therapeutic Goods Act 1989.

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Endnotes

Endnote 3—Application, saving and transitional provisions

540 Therapeutic Goods Act 1989

Schedule 3

16 Application

(1) The amendments made by items 1 to 9 apply in relation to the

registration or listing of therapeutic goods before, on or after the

commencement of those items.

(2) The amendments made by items 10 and 11 apply in relation to

conformity assessment certificates issued before, on or after the

commencement of those items.

(3) The amendments made by items 12 and 13 apply in relation to the

inclusion of a kind of medical device in the Register before, on or after

the commencement of those items.

Schedule 5

5 Application

The amendments made by items 1 and 2 apply in relation to

applications for listings made on or after the commencement of those

items.

Schedule 6

14 Saving and transitional

Standards

(1) The amendment made by item 1 does not affect the validity of an order

made under section 10 of the Therapeutic Goods Act 1989 before the

commencement of this item.

(2) The repeal of section 11 of the Therapeutic Goods Act 1989 by this

Schedule does not apply to an order made under section 10 of that Act

before the commencement of this item.

Medical device standards

(3) The amendment made by item 8 does not affect the validity of an order

made under section 41CB of the Therapeutic Goods Act 1989 before the

commencement of this item.

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Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 541

(4) Subsection 41CB(2) of the Therapeutic Goods Act 1989, as in force

immediately before the commencement of this item, continues to apply

on and after that commencement in relation to an order made under

section 41CB of that Act before that commencement.

Conformity assessment standards

(5) The amendment made by item 11 does not affect the validity of an order

made under section 41DC of the Therapeutic Goods Act 1989 before

the commencement of this item.

(6) Subsection 41DC(3) of the Therapeutic Goods Act 1989, as in force

immediately before the commencement of this item, continues to apply

on and after that commencement in relation to an order made under

section 41DC of that Act before that commencement.

Schedule 7

26 Application—listings of medicines

The amendments made by items 5 to 10 apply in relation to applications

for listings of medicines made on or after the commencement of those

items.

27 Application—revocation of cancellation of registration or listing upon request

The amendment made by item 14 applies in relation to cancellations

occurring before, on or after the commencement of that item.

28 Saving—device nomenclature codes

Despite the amendment made by item 22, regulations in force for the

purposes of subsection 41BE(3) of the Therapeutic Goods Act 1989

immediately before the commencement of this item continue in force,

after that commencement, until the first determination made under that

subsection (as inserted by this Act) takes effect.

56 Saving—Therapeutic Goods Advertising Code

(1) Despite the amendment made by item 29, the Therapeutic Goods

Advertising Code as in force immediately before the commencement of

this item continues in force, after that commencement, until the first

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Endnotes

Endnote 3—Application, saving and transitional provisions

542 Therapeutic Goods Act 1989

instrument made under section 42BAA of the Therapeutic Goods Act

1989, as inserted by this Act, takes effect.

(2) Despite the amendment made by item 52, regulations in force for the

purposes of section 42DD of the Therapeutic Goods Act 1989

immediately before the commencement of this item continue in force,

after that commencement, until the first instrument made under

section 42BAA of the Therapeutic Goods Act 1989, as inserted by this

Act, takes effect.

(3) Despite the amendment made by item 54, regulations in force for the

purposes of paragraph 42DF(4)(c) of the Therapeutic Goods Act 1989

immediately before the commencement of this item continue in force,

after that commencement, until the first instrument made under

section 42BAA of the Therapeutic Goods Act 1989, as inserted by this

Act, takes effect.

57 Application and transitional—registration or listing conditions

(1) Subsection 28(1) of the Therapeutic Goods Act 1989, as inserted by this

Act, applies in relation to the registration or listing of therapeutic goods

occurring before, on or after the commencement of this item.

(2) Subsection 28(2B) of the Therapeutic Goods Act 1989, as inserted by

this Act, applies in relation to the registration or listing of therapeutic

goods occurring on or after the commencement of this item.

(3) Conditions in force under subsection 28(1) of the Therapeutic Goods

Act 1989 immediately before the commencement of this item continue

in force, on and after that commencement, as if they had been imposed,

on that commencement, under subsection 28(2B) of the Therapeutic

Goods Act 1989.

(4) Subitem (3) does not prevent the variation or removal of the conditions

under subsection 28(3) of the Therapeutic Goods Act 1989 on or after

the commencement of this item.

(5) The amendment made by item 31 applies in relation to:

(a) conditions imposed under subsection 28(2B) of the

Therapeutic Goods Act 1989 on or after the commencement

of that item (including because of subitem (3)); and

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Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 543

(b) conditions imposed under subsection 28(3) of the

Therapeutic Goods Act 1989 before, on or after the

commencement of that item.

(6) The amendment made by item 34 applies in relation to the registration

or listing of therapeutic goods occurring before, on or after the

commencement of that item.

(7) The amendment made by item 36 applies in relation to the listing of

medicine occurring before, on or after the commencement of that item.

(8) This item does not affect the conditions to which the registration or

listing of therapeutic goods is subject before the commencement of this

item.

58 Application—information gathering

(1) The amendments made by items 38 and 40 apply in relation to periods

beginning before, on or after the commencement of those items.

(2) The amendment made by item 41 applies in relation to things occurring

before, on or after the commencement of that item.

(3) Regulations in force for the purposes of subsection 41JA(2) of the

Therapeutic Goods Act 1989 immediately before the commencement of

this item continue in force for the purposes of that subsection on and

after that commencement.

59 Application—advertisements

The amendments made by items 44 to 50 apply in relation to

advertisements published or broadcast on or after the commencement of

those items.

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Endnotes

Endnote 3—Application, saving and transitional provisions

544 Therapeutic Goods Act 1989

Therapeutic Goods Amendment (2009 Measures No. 2) Act 2009 (No. 96,

2009)

Schedule 1

13 Saving and transitional

(1) The amendment made by item 10 does not affect the validity of an

instrument made under paragraph 52D(2)(a) or (b) of the Therapeutic

Goods Act 1989 before the commencement of that item.

(2) If:

(a) on or after 1 January 2010 and before the commencement of

this item, the Committee referred to in section 52B of the

Therapeutic Goods Act 1989 had proposed an amendment of

the current Poisons Standard; and

(b) before that commencement, that Committee had not amended

the current Poisons Standard as a result of that proposal;

then the Secretary must have regard to that proposal in relation to

making the first instrument under subsection 52D(2) of that Act on or

after that commencement.

(3) If:

(a) on or after 1 January 2010 and before the commencement of

this item, an application was made to the Committee referred

to in section 52B of the Therapeutic Goods Act 1989 for an

amendment of the current Poisons Standard; and

(b) the application had not been refused by that Committee

before that commencement; and

an amendment of the current Poisons Standard as a result of

the application;

then the application has effect on and after that commencement as if it

were an application made to the Secretary in accordance with

section 52EAA of that Act.

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Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 545

Schedule 2

4 Application

The amendments made by items 2 and 3 apply in relation to

applications made after the day on which the first instrument made

under section 41BEA of the Therapeutic Goods Act 1989 takes effect.

Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

Schedule 3

7 Application and saving

(1) The amendments made by items 2 and 5 apply in relation to

advertisements occurring on or after the commencement of those items.

(2) The amendment made by item 3 applies in relation to applications made

on or after the commencement of that item.

(3) The amendment made by item 4 does not affect the validity of a request

made under subsection 30D(1) of the Therapeutic Goods Act 1989

before the commencement of that item.

10 Application

The amendment made by item 8 applies in relation to applications for

the registration or listing of medicine made on or after the

commencement of this Part.

Therapeutic Goods Amendment (2009 Measures No. 3) Act 2010 (No. 54,

2010)

Schedule 1

58 Application—licences

The amendment made by item 31 applies in relation to licences granted

before, on or after the commencement of that item.

59 Transitional—exempt biologicals

(1) This item applies in relation to a class of biologicals that, immediately

before the commencement of this item, was covered by an exemption of

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Endnotes

Endnote 3—Application, saving and transitional provisions

546 Therapeutic Goods Act 1989

the kind referred to in paragraph 18(1)(c) of the Therapeutic Goods Act

1989.

(2) At the commencement of this item, there is taken to be an exemption

(the transitional exemption) in force under subsection 32CA(2) of that

Act covering that class of biologicals.

(3) Subject to this item, the transitional exemption ceases to be in force at

the end of the period (the transitional period) of 3 years beginning on

the day this item commences.

(4) If:

(a) before the end of the period of 18 months beginning on the

day this item commences, a person makes an application in

accordance with section 32DA or 32DD of that Act to

include in the Register a biological included in that class; and

(b) before the end of the transitional period, the person has not

been notified of the Secretary’s decision on the application;

the transitional exemption, in relation to that biological, continues in

force past the end of the transitional period until the person is notified

of the Secretary’s decision on the application.

(5) If:

(a) before the end of the transitional period, a person makes an

application in accordance with section 32DA or 32DD of that

Act to include in the Register a biological included in that

class; and

(b) before the end of that period, the person is notified of the

Secretary’s decision on the application;

the transitional exemption, in relation to that biological, ceases to be in

force immediately after that notification.

60 Transitional regulations

The Governor-General may make regulations prescribing matters of a

transitional nature (including prescribing any saving or application

provisions) relating to the amendments made by this Schedule.

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Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 547

Schedule 2

15 Application

The amendment made by item 14 applies in relation to anything done or

omitted to be done on or after the commencement of that item.

16 Saving

Despite the repeal of provisions of the Therapeutic Goods Act 1989

made by items 1, 2, 4 to 8 and 10 to 13, those provisions (as in force

immediately before the commencement of those items) continue to

apply on and after that commencement in relation to anything done or

omitted to be done before that commencement.

Schedule 3

3 Application

The amendments made by items 1 and 2 apply in relation to therapeutic

goods, and kinds of medical devices, included in the Register before, on

or after the commencement of those items.

Schedule 4

6 Application

(1) The amendments made by items 1 to 5 apply in relation to notices given

on or after the commencement of those items.

(2) Paragraphs 31(1)(ac) and (2)(ac) of the Therapeutic Goods Act 1989, as

inserted by this Act, apply in relation to the registration or listing of

therapeutic goods occurring before, on or after the commencement of

this item.

Schedule 5

2 Application

The amendment made by item 1 applies in relation to an annual

registration charge, an annual listing charge, an annual charge for

inclusion in the Register or an annual licensing charge that becomes

payable on or after the day on which that item commences.

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Endnotes

Endnote 3—Application, saving and transitional provisions

548 Therapeutic Goods Act 1989

Schedule 6

20 Application

(1) The amendment made by item 3 applies in relation to requests made on

or after the commencement of that item.

(2) The amendments made by items 4 and 5 apply in relation to

advertisements published or broadcast on or after the commencement of

those items.

(3) The amendments made by items 8 to 15 and 17 to 19 apply in relation

to requests made to the Minister to reconsider decisions, where the

requests are made on or after the commencement of those items

(regardless of whether the decisions were made before, on or after that

commencement).

Therapeutic Goods Amendment (2010 Measures No. 1) Act 2010 (No. 141,

2010)

Schedule 1A

10 Application

(1) Paragraph 23(2)(ba) and subparagraph 25(1)(da)(i) of the Therapeutic

Goods Act 1989, as inserted by this Act, apply in relation to

applications for registration of medicine that are made after the day on

which the first instrument made under subsection 3(2A) or (2B) of that

Act takes effect.

(2) Subparagraph 25(1)(da)(ii) of the Therapeutic Goods Act 1989, as

inserted by this Act, applies in relation to applications for registration of

medicine that are made on or after the day on which the first instrument

made under subsection 3(2A) or (2B) of that Act takes effect.

(3) Subparagraph 25(4)(d)(ia) of the Therapeutic Goods Act 1989, as

inserted by this Act, applies on and after the day on which the first

instrument made under subsection 3(2A) or (2B) of that Act takes effect

(whether the application for registration was made before, on or after

that day).

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Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 549

(4) Subsection 25AA(1) of the Therapeutic Goods Act 1989, as inserted by

this Act, applies in relation to medicine included in the Register on or

after the day on which the first instrument made under subsection 3(2A)

or (2B) of that Act takes effect (where the notification (in relation to the

medicine) referred to in subparagraph 25(4)(d)(ia) of that Act also

occurred on or after that day).

Note: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

Schedule 2

7 Application

(1) The amendments made by items 1A to 1D apply in relation to requests

made on or after the commencement of those items.

(2) The amendment made by item 1E applies in relation to applications for

registration made on or after the commencement of that item.

(3) The amendments made by items 1 and 2 apply in relation to

applications for listings made on or after the commencement of those

items.

(4) The amendment made by item 6A applies in relation to a notice given

on or after the commencement of that item (whether the application or

request was made before, on or after that commencement).

21 Application

(1) The amendments made by items 8 and 9 apply in relation to

applications for listings made on or after the commencement of those

items.

(2) The amendments made by items 10 to 15 apply in relation to notices

given on or after the commencement of those items.

(2A) The amendment made by item 15A applies in relation to notices given

on or after the commencement of that item.

(3) The amendments made by items 16 and 17 apply in relation to

applications made on or after the commencement of those items.

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Endnotes

Endnote 3—Application, saving and transitional provisions

550 Therapeutic Goods Act 1989

(4) The amendments made by items 18 and 19 apply in relation to initial

decisions made on or after the commencement of those items.

Acts Interpretation Amendment Act 2011 (No. 46, 2011)

Schedule 3

10 Saving—appointments

The amendments made by Schedule 2 do not affect the validity of an

appointment that was made under an Act before the commencement of

this item and that was in force immediately before that commencement.

11 Transitional regulations

The Governor-General may make regulations prescribing matters of a

transitional nature (including prescribing any saving or application

provisions) relating to the amendments and repeals made by

Schedules 1 and 2.

Therapeutic Goods Amendment (2011 Measures No. 1) Act 2011 (No. 77,

2011)

Schedule 1

6 Application

(1) The amendment made by item 1 applies in relation to requests made on

or after the commencement of that item.

(2) The amendments made by items 2 to 4 apply in relation to applications

made under section 23 of the Therapeutic Goods Act 1989 on or after

the commencement of those items.

(3) The amendment made by item 5 applies in relation to notices given on

or after the commencement of that item.

7 Transitional—approved forms

An approval in force under subsection 9D(6) of the Therapeutic Goods

Act 1989 immediately before the commencement of this item continues

in force on and after that commencement as if it were an approval in

force under paragraph 9D(6)(a) of that Act.

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Endnotes

Endnote 3—Application, saving and transitional provisions

Therapeutic Goods Act 1989 551

8 Transitional—registration or listing conditions

(1) If:

(a) on or after the day on which this item commences, the first

instrument made under subsection 28(2) of the principal Act

takes effect; and

(b) immediately before that first instrument takes effect, a

condition on the registration or listing of therapeutic goods

was in force under subsection 28(2B) of the principal Act;

and

(i) if that condition was in force because of subitem 57(3)

of Schedule 7 to the amending Act—that condition was

imposed in writing under subsection 28(1) of the

principal Act (as in force at any time before 25 January

2010) and was described as a standard condition; or

(ii) in any other case—that condition was imposed by notice

in writing under subsection 28(2B) of the principal Act

and was described as a standard condition;

then that condition ceases to be in force at the time that first instrument

takes effect.

Note 1: If, immediately before that first instrument takes effect, multiple conditions on the registration or listing of therapeutic goods were in force under subsection 28(2B) of the principal Act, this item has a separate application in relation to each of those conditions.

Note 2: Section 12 of the Legislative Instruments Act 2003 deals with when a legislative instrument takes effect.

(2) Subitem 57(1) of Schedule 7 to the amending Act is subject to an

instrument under subsection 28(2) of the principal Act providing that

specified conditions apply only to a specified class of therapeutic goods

that are registered or listed on or after that instrument takes effect.

(3) In this item:

amending Act means the Therapeutic Goods Amendment (2009

Measures No. 1) Act 2009.

principal Act means the Therapeutic Goods Act 1989.

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Endnotes

Endnote 4—Uncommenced amendments

552 Therapeutic Goods Act 1989

Endnote 4—Uncommenced amendments

This endnote sets out amendments of the Therapeutic Goods Act 1989 that have

not yet commenced.

There are no uncommenced amendments.

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Endnotes

Endnote 5—Misdescribed amendments

Therapeutic Goods Act 1989 553

Endnote 5—Misdescribed amendments

This endnote sets out amendments of the Therapeutic Goods Act 1989 that have

been misdescribed.

There are no misdescribed amendments.

ComLaw Authoritative Act C2013C00132

Loi sur les biens thérapeutiques n° 21 de 1989, (version consolidée du 11 Décembre 2012), Australie

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