Therapeutic Goods Act 1989, Australia

Subdivision B—Suspension as a result of suspension under

Part 4-4 211 41GF Suspension of kinds of medical devices from the Register............211 41GG Duration of suspension..................................................................212 41GH Revocation of suspension..............................................................212

Subdivision C—Effect of suspension 212 41GI Effect of suspension ......................................................................212 41GJ Powers of cancellation from Register unaffected..........................213

Division 2—Cancellation of entries from the Register 214 41GK Automatic cancellation of entries of kinds of medical devices from the Register...........................................................................214 41GL Immediate cancellation of entries of kinds of medical devices from the Register..............................................................214 41GM Cancellation of entries of kinds of medical devices from the Register after section 41JA notice.................................................215 41GN Cancellation of entries of kinds of medical devices from the Register after notice of proposed cancellation...............................216 41GO Limiting cancellation of entries from Register to some

medical devicesof a particular kind..............................................217 41GP Publication of cancellation of entry from Register........................217 41GQ Date of effect of cancellation ofentriesfrom Register..................218

Part 4-6A—Exempting medical devices to deal with emergencies 219 41GR What this Part is about...................................................................219 41GS Minister may make exemptions.....................................................219 41GT Conditions of exemptions..............................................................220 41GU Variation or revocation of exemption............................................221 41GV Informing persons of exemption etc..............................................222 41GW Notification and tabling.................................................................222 41GY Disposal of unused medical devices..............................................223

Part 4-7—Other exemptions from including medical devices in the Register 224 41H What this Part is about...................................................................224 41HA Devices exempted from inclusion in the Register..........................224 41HB Exemptionsforspecialand experimental uses..............................225 41HC Exemptions for medical practitioners............................................226 41HD Approvals if substitutes for medical devices are unavailable or in short supply...........................................................................227

Part 4-8—Obtaining information 231 41J What this Part is about...................................................................231

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

(c)

the application has not been, and is not, withdrawn either

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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 15A

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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

However, this subsection does not apply after the end of 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; or

(b)

a different strength or size (disregarding pack size); or

(c)

a different dosage form or model; 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

(c)

a different dosage form; 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.

(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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 18

(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

(c)

available for inspection (whether by using a visual display 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

(c)

a specified class of therapeutic goods;

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.

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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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.

(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

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 18A

(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;

(c)

the source of those goods;

(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.

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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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 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);

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 19

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.);

(c)

section 30G (disposal of unused goods);

(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).

(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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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;

(c)

the monitoring of the use, and the results of the use, of the goods for those purposes;

(d)

the circumstances in which the person must cease the use of the goods for those purposes.

(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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 19A

(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

(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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(ii) an application that complies with section 23 has been made under that section for registration of the goods; and

(c)

the goods are of a kind:

(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

(c)

the goods are of a kind:

(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.

(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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 19B

(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

(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;

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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

(c) 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: 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.

(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;

(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

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 19B

(c) 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: 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.

(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.

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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

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:

(c)

prohibited imports within the meaning of that Act; or

(d)

prohibited exports within the meaning of that Act; 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

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 19C

(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:

(c)

inform the defendant of the requirements of this section; and

(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

(c)

if the name or address is not included in the notice, but the 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; or

(ii)

if the defendant later receives any such information— the defendant immediately gives notice of the information.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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:

(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:

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 19D

(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

(c)

the registration number or listing number of the goods is not 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:

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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

(c)

the registration number or listing number of the goods is not 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:

(c)

prohibited imports within the meaning of that Act; or

(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:

(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

(c)

the person has not, at the time of the importation, export, manufacture or supply, properly notified to the Secretary either or both of the following:

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 20

(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

(c)

the importation breaches a condition of the exemption.

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:

(a)

the person imports therapeutic goods into Australia; and

(b)

the goods are exempt under section 18A; and

(c)

the importation breaches a condition of the exemption.

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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

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

(c)

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 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:

(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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 21

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

(c)

the goods are the subject of an approval or authority under 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

(c)

the statement is false or misleading in a material particular; 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: 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 makes a statement; and

(b)

the statement is made in or in connection with a certification of any matter under subsection 26A(2); and

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(c)

the statement is false or misleading in a material particular; 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.

(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

(c)

the statement is false or misleading in a material particular.

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

(c)

the act or omission breaches a condition of the registration or 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.

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)

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

(c)

the act or omission breaches a condition of the registration or listing of the goods; and

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 21A

(d) the act or omission is likely 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)

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

(c)

the act or omission breaches a condition of the registration or 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

(c)

any of the following applies:

(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)

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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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

(c)

any of the following applies:

(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).

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

(c)

the goods are not:

(i) exempt goods; or

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 21A

(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:

(i)

in the treatment of another person; or

(ii)

solely for experimental purposes in humans; and

(c)

the goods are not:

(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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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.

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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 22

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

(c)

the person represents therapeutic goods that are not goods 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 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

(c)

the indication is not an indication accepted in relation to that inclusion.

Penalty: 60 penalty units.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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); or

(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

(c)

the act or omission results in the breach of a condition of the 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 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.

(7AC) Strict liability applies to paragraph (7AB)(b).

Note: For strict liability, see section 6.1 of the Criminal Code.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 22AA

(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

(c)

the act or omission results in the breach of a condition of the 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

(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

(c)

the act or omission breaches a condition of the exemption.

Maximum civil penalty:

(a) for an individual—5,000 penalty units; and

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Preliminary Division 1

(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

(c)

the statement is false or misleading in a material particular; 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: 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 makes a statement; and

(b)

the statement is made in or in connection with an application for registration of therapeutic goods; and

(c)

the statement is false or misleading in a material particular; 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.

(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

(c)

the statement is false or misleading in a material particular.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 1 Preliminary

Section 22B

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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

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

(c) if the Secretary so requires—the applicant has delivered to 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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 24A

(2)

Subject to section 24D, 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; or

(b)

the application contains information that is inaccurate or misleading in a material particular; or

(c)

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 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 sections 24B and 24D, 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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(b) any assessment fee under section 41LA 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).

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 Reduction 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)

Nothing in section 24, 24A or 24B requires the applicant to pay more than three-quarters of the evaluation fee before the completion of the evaluation of the goods.

(3)

If the evaluation is not completed within the period referred to in subsection (1), this Act has effect as if the evaluation fee were reduced to three-quarters of the fee that, under the regulations, would have been the evaluation fee.

(4)

If:

(a)

the evaluation is completed within the period referred to in subsection (1); and

(b)

part of the evaluation fee under section 24 is unpaid when the

evaluation is completed; that part becomes due and payable on the completion of the evaluation.

(5)

For the purposes of subsections (2), (3) and (4), the evaluation is to be taken to be completed when the applicant is notified according to subsection 25(3) or (4) of the Secretary’s decision on the application.

(6)

Despite subsection (5), if:

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 24E

(a)

the Secretary has given the applicant all evaluation reports relating to the application; and

(b)

the Secretary has given those reports, or proposes to give those reports, to a committee established under the regulations to advise the Secretary on applications to register therapeutic goods to which subsection (1) applies; and

(c)

the applicant withdraws the application after being given the reports, and before the end of the period mentioned in subsection (1);

the evaluation is taken for the purposes of subsections (2), (3) and

(4) to be completed immediately before the time of withdrawal.

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:

(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

(c)

the Minister’s decision had been made on the day on which 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:

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(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

(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

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 25

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.

(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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(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:

(c)

notify the applicant in writing of his or her decision on the 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.

(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:

(c) notify the applicant in writing of his or her decision on the evaluation within 28 days of the making of the decision and,

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 25AA

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.

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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

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

(c)

on or after that day and in relation to that application, the Secretary includes the medicine in the Register in relation to the person under subparagraph 25(4)(d)(ii);

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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 25A

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 Register in relation to the medicine; or

(ii)

there is a change in the conditions to which the inclusion of the medicine is subject; and

(c)

as a result of that variation or change, the Secretary is 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

(b)

the information is about the active component and is not available to the public; and

(c)

when the application to register the new goods was lodged:

(i) no other therapeutic goods consisting of, or containing, that active component were included in the Register; and

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(ii) no such therapeutic goods had been included in the Register at any time before then; and

(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.

(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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 26

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:

(c)

the goods are not eligible for listing; or

(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

(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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(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

(c)

the Secretary is satisfied that paragraphs (1)(a) to (ba) are 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

(c)

the other requirements in subsection (1) are met;

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:

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 26

(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.

(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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(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

(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

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 26A

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

(c)

the requirements of subsection (2) and (where applicable) 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

(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

(c)

the other requirements in subsection (1) are met;

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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(b)

the medicine is safe for the purposes for which it is to be used; and

(c)

the presentation of the medicine is not unacceptable; 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

(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

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 26A

(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

(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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(c) whether the applicant has complied with any requirements 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:

(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:

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 26B

(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.

(4)

In this section:

patent has the same meaning as in the Patents Act 1990.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

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:

(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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 26BC

(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

(c)

be delivered to an office of the Department specified in the 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. This subsection does not limit the matters to which the Minister may have regard to in deciding whether to vary the determination.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

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

(c)

will be conducted without unreasonable delay.

The certificate must be signed by, or on behalf of, the second person and must be in a form approved by the Secretary.

(4) For the purpose of paragraph (3)(b), proceedings have reasonable prospects of success if:

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 26C

(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

(c)

the proceedings are not otherwise vexatious or unreasonably 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; or

(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).

(8)

If:

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(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

(c)

a prescribed court declares that the second person has given a 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 subsection (1) unless the Attorney-General gives written notice to the prescribed court that he or she does not desire to be a party.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 26D

(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; or

(b)

the principal proceedings are dismissed; and

(c)

in either case, the prescribed court declares that:

(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 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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(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

(c)

award to a State or a Territory compensation for any damages 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 Register, the Secretary is to assign a single, unique registration or 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; or

(c)

the keeping of records relating to the goods; or

(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.

(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

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 28

(c) different classes of therapeutic goods.

(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

(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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

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

(c)

in relation to each batch of the subject goods—keep a record, 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 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

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 28

(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:

(c)

a condition that the sponsor of the goods had, at the time 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).

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

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.

(2)

The information with which subsection (1) is concerned is information of the following kinds:

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 29AA

(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;

(c)

information that indicates that the goods, when used in 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

(c)

the person does not give the information to the Secretary in 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;

(c)

information that indicates that the goods, when used in 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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

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.

(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.

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:

(a)

for an individual—3,000 penalty units; and

(b)

for a body corporate—30,000 penalty units.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 29D

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

(b)

give the person a reasonable opportunity to make submissions to the Secretary in relation to the proposed suspension.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(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.

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.

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 29F

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.

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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

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

(c)

the person requests in writing the cancellation of the 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 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

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 30

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

(c)

there is a serious breach, involving the medicine, 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 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

(c)

the person fails to comply with the notice within 20 working days after the notice is given.

(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

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(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

(c) the sponsor has refused or failed to comply with a condition 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.

(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:

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 30A

(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

(c)

the request is accompanied by the prescribed application fee;

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

(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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Registration and listing Division 2

(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.

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:

(c)

ensure that the advice is taken into account in making a decision on the application to which the notice relates, or on

Chapter 3 Medicines and other therapeutic goods that are not medical devices Part 3-2 Registration and listing of therapeutic goods Division 2 Registration and listing

Section 30E

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.

Medicines and other therapeutic goods that are not medical devices Chapter 3 Registration and listing of therapeutic goods Part 3-2 Public notification and recovery of therapeutic goods Division 2A