Propiedad intelectual Formación en PI Respeto por la PI Divulgación de la PI La PI para... La PI y… La PI en… Información sobre patentes y tecnología Información sobre marcas Información sobre diseños industriales Información sobre las indicaciones geográficas Información sobre las variedades vegetales (UPOV) Leyes, tratados y sentencias de PI Recursos de PI Informes sobre PI Protección por patente Protección de las marcas Protección de diseños industriales Protección de las indicaciones geográficas Protección de las variedades vegetales (UPOV) Solución de controversias en materia de PI Soluciones operativas para las oficinas de PI Pagar por servicios de PI Negociación y toma de decisiones Cooperación para el desarrollo Apoyo a la innovación Colaboraciones público-privadas Herramientas y servicios de IA La Organización Trabajar con la OMPI Rendición de cuentas Patentes Marcas Diseños industriales Indicaciones geográficas Derecho de autor Secretos comerciales Academia de la OMPI Talleres y seminarios Observancia de la PI WIPO ALERT Sensibilizar Día Mundial de la PI Revista de la OMPI Casos prácticos y casos de éxito Novedades sobre la PI Premios de la OMPI Empresas Universidades Pueblos indígenas Judicatura Recursos genéticos, conocimientos tradicionales y expresiones culturales tradicionales Economía Financiación Activos intangibles Igualdad de género Salud mundial Cambio climático Política de competencia Objetivos de Desarrollo Sostenible Tecnologías de vanguardia Aplicaciones móviles Deportes Turismo PATENTSCOPE Análisis de patentes Clasificación Internacional de Patentes ARDI - Investigación para la innovación ASPI - Información especializada sobre patentes Base Mundial de Datos sobre Marcas Madrid Monitor Base de datos Artículo 6ter Express Clasificación de Niza Clasificación de Viena Base Mundial de Datos sobre Dibujos y Modelos Boletín de Dibujos y Modelos Internacionales Base de datos Hague Express Clasificación de Locarno Base de datos Lisbon Express Base Mundial de Datos sobre Marcas para indicaciones geográficas Base de datos de variedades vegetales PLUTO Base de datos GENIE Tratados administrados por la OMPI WIPO Lex: leyes, tratados y sentencias de PI Normas técnicas de la OMPI Estadísticas de PI WIPO Pearl (terminología) Publicaciones de la OMPI Perfiles nacionales sobre PI Centro de Conocimiento de la OMPI Informes de la OMPI sobre tendencias tecnológicas Índice Mundial de Innovación Informe mundial sobre la propiedad intelectual PCT - El sistema internacional de patentes ePCT Budapest - El Sistema internacional de depósito de microorganismos Madrid - El sistema internacional de marcas eMadrid Artículo 6ter (escudos de armas, banderas, emblemas de Estado) La Haya - Sistema internacional de diseños eHague Lisboa - Sistema internacional de indicaciones geográficas eLisbon UPOV PRISMA UPOV e-PVP Administration UPOV e-PVP DUS Exchange Mediación Arbitraje Determinación de expertos Disputas sobre nombres de dominio Acceso centralizado a la búsqueda y el examen (CASE) Servicio de acceso digital (DAS) WIPO Pay Cuenta corriente en la OMPI Asambleas de la OMPI Comités permanentes Calendario de reuniones WIPO Webcast Documentos oficiales de la OMPI Agenda para el Desarrollo Asistencia técnica Instituciones de formación en PI Apoyo para COVID-19 Estrategias nacionales de PI Asesoramiento sobre políticas y legislación Centro de cooperación Centros de apoyo a la tecnología y la innovación (CATI) Transferencia de tecnología Programa de Asistencia a los Inventores (PAI) WIPO GREEN PAT-INFORMED de la OMPI Consorcio de Libros Accesibles Consorcio de la OMPI para los Creadores WIPO Translate Conversión de voz a texto Asistente de clasificación Estados miembros Observadores Director general Actividades por unidad Oficinas en el exterior Ofertas de empleo Adquisiciones Resultados y presupuesto Información financiera Supervisión
Arabic English Spanish French Russian Chinese
Leyes Tratados Sentencias Consultar por jurisdicción

Decisión Nº 30/2006/QD-BYT, de 30 de septiembre de 2006, por la que se promulga el Reglamento sobre la seguridad de los datos de los expedientes de registro de medicamentos, Viet Nam

Atrás Texto derogado 
Detalles Detalles Año de versión 2006 Fechas Entrada en vigor: 11 de noviembre de 2006 Adoptado/a: 30 de septiembre de 2006 Tipo de texto Normas/Reglamentos Materia Información no divulgada (Secretos Comerciales), Otros Notas En la notificación de Viet Nam a la OMC de conformidad con el artículo 63.2 del Acuerdo sobre los ADPIC se establece lo siguiente:
'La Decisión promulga la normativa sobre la protección de los datos aplicada a los expedientes de registro de productos farmacéuticos (la protección de la confidencialidad de los datos de pruebas presentados en los procedimientos para la aprobación de la comercialización de productos farmacéuticos).'

Documentos disponibles
Textos principales Textos relacionados
Textos principales Textos principales Inglés Decision No. 30/2006/QD-BYT of September 30, 2006, promulgating the Regulation on Data Security of Drug Registration Records        
Decision No. 30/2006/QD-BYT of September 30, 2006, promulgating the Regulation on Data Security of Drug Registration Records

DECISION No. 30/2006/QD-BYT OF SEPTEMBER 30, 2006, PROMULGATING THE

REGULATION ON DATA SECURITY OF DRUG REGISTRATION RECORDS

THE MINISTER OF HEALTH

Pursuant to the June 14, 2005 Pharmacy Law;

Pursuant to the November 29, 2005 Intellectual Property Law;

Pursuant to the Government’s Decree No. 103/2006/ND-CP of September 22, 2006, detailing and guiding the implementation of a number of articles of the Intellectual Property Law regarding industrial property;

Pursuant to the Government’s Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Pursuant to Official Letter No. 200/UB-VP of September 22, 2006, of the National Committee for International Economic Cooperation, notifying the results of negotiations with the United States on the protection of test data;

At the proposal of the Director of the Vietnam Drug Administration,

DECIDES:

Article 1.- To promulgate together with this Decision the Regulation on data security of drug registration records.

Article 2.- This Decision takes effect 15 days after its publication in “CONG BAO.”

Article 3.- The director of the Office and the director of the Inspectorate of the Health Ministry, the directors of the Vietnam Drug Administration and the Preventive Medicine Department, heads of units under the Health Ministry, directors of provincial/municipal Health Services, and heads of concerned drug-trading establishments, testing establishments and medical treatment establishments shall implement this Decision.

Minister of Health

TRAN THI TRUNG CHIEN

REGULATION ON DATA SECURITY OF DRUG REGISTRATION RECORDS

GENERAL PROVISIONS

Article 1.- Scope of regulation and subjects of application

1. Scope of regulation: This Regulation provides the order and procedures related to the security of data of drug registration records.
2. Subjects of application: This Regulation applies to domestic and foreign organizations and individuals that carry out drug registration procedures in Vietnam and to concerned agencies in charge of state management of pharmacy.

Article 2.- Interpretation of terms

In this Regulation, the terms below are construed as follows:
1. Drug means a substance or a mixture of substances for human use for the purposes of disease prevention, treatment or diagnosis or rehabilitation of human physical functions, including finished drugs, drug materials, vaccines and medical biologicals, except functional foodstuff.
2. Pharmaceutical substance (also referred to as active ingredient) means a substance or a mixture of substances having treatment active-ingredients which are used in drug manufacture.
3. New drug means a drug containing a new pharmaceutical substance or drug with a new combination of circulated pharmaceutical substances.
4. Clinical drug test means a scientific research into drugs on humans in a systematic manner with a view to verifying clinical efficiency, identifying and discovering harmful effects of the researched products; the ability of such products to absorb, distribute, transform or discharge, aiming to determine the safety and effectiveness of drugs.
5. Additional indication, formula or preparation form means a new indication, new formula or new preparation form of a new drug which has been granted a circulation registration number.
6. Business secret means information received from financial investment or intellectual activities which has not been revealed and can be used in business activities.
7. Data security means the application of necessary measures to ensure that data are neither used for unhealthy commercial purposes nor revealed, unless when the revelation is necessary for the protection of people.

Article 3.- Types of data to be secured

1. Test results related to toxicity and clinical drug test data of new drugs which have never been publicized or revealed.
2. Other data (except additional indications, formulas and preparation forms) which meet the conditions specified in Article 4 of this Regulation.

Article 4.- Conditions for data to be secured

Data to be secured must fully meet the following conditions:
1. Being business secrets.
2. Being results of investment of significant efforts.
3. Being supplied by drug-registering establishments under current regulations on drug registration.
4. Being requested to be secured by drug-registering establishments under the provisions of Article 5 of this Regulation.

Article 5.- Required documents for data security consideration

1. Required documents include:
a/ An application for enforcement of data security (made according to a set form);
b/ A document proving that data which need be secured fully meet the conditions specified in
Clause 1, Article 4 of this Regulation.
c/ A document proving that data which need be secured are under lawful ownership of the drug- registering establishment which requests the enforcement of data security.
2. The application for enforcement of data security and proof documents specified in Clause 1 of this Article constitute part of a drug registration dossier and must be submitted together with the dossier. Applications and documents submitted after drug registration dossiers shall not be considered.

Article 6.- Forms of applications and documents related to data security enforcement request

1. An application for enforcement of data security and enclosed documents must be made in Vietnamese or English, signed and stamped for certification by the drug-registering establishment on every page of those documents.
2. Legal documents (diplomas, certificates, etc.) must be originals or copies notarized in Vietnam. Diplomas and certificates which are issued, notarized or authenticated by foreign agencies or organizations must be legalized by consular offices and translated into Vietnamese. The translations must be notarized in accordance with Vietnamese law.
3. Parts of a dossier which contain data to be secured must be sealed and appended with a confidentiality stamp of the drug-registering establishment.
Chapter II
PROCEDURES FOR SUBMISSION AND RECEIPT OF DRUG REGISTRATION DOSSIERS CONTAINING DATA TO BE SECURED

Article 7.- Submission of dossiers

1. A drug registration dossier containing data which need be secured and relevant proof documents shall be submitted directly at the drug circulation-licensing agency or at the place of receipt of dossiers designated by the drug circulation-licensing agency, or shall be sent by registered mail.
2. If, at the time the drug registration dossier is being submitted (or arriving at the drug circulation- licensing agency), the parts of data which need be secured no longer have confidentiality signs or intact seals, the drug circulation-licensing agency shall not be responsible for data security.

Article 8.- Receipt of dossiers

Upon receiving a drug registration dossier containing data which need be secured, the drug circulation-licensing agency shall:
1. Inspect the intactness of the dossier and its confidentiality seal.
2. Check documents in the dossier against those listed in the application for enforcement of data security.
3. Append a stamp on the application and all enclosed documents, certifying the date of receipt of the dossier; and write down necessary information in the dossier receipt book.
4. Temporarily keep data which need be secured according to current regulations until it officially accepts or rejects the application for enforcement of data security.
Chapter III
RESPONSIBILITIES OF THE DRUG CIRCULATION-LICENSING AGENCY

Article 9.- Consideration of and reply to a data security enforcement request

1. Within six months after receiving a drug registration dossier containing data which need be secured, the drug circulation-licensing agency shall evaluate the application for enforcement of data security and relevant documents required in Articles 3, 4, 5 and 6 of this Regulation and notify in writing the drug-registering establishment of its acceptance or rejection of the data security enforcement request.
2. If rejecting a data security enforcement request, the drug circulation-licensing agency shall clearly state the reasons therefor.

Article 10.- Security enforcement and duration

1. For data to be secured, the drug circulation-licensing agency shall take necessary security measures as stipulated in Clause 1, Article 128 of the Intellectual Property Law until those data no longer meet the conditions specified in Article 4 of this Regulation.
2. Except the case defined at Point d, Clause 2, Article 125 of the Intellectual Property Law, within 5 years after the drugs for which the drug registration dossier containing confidential is submitted to the drug circulation-licensing agency are granted circulation permits, the drug circulation-licensing agency may not license any drug-registering establishments which submit later dossiers with the same confidential data without consent of the person who has submitted those data.

Article 11.- Processing of data after security duration

At the end of the security duration stipulated in Article 10 of this Regulation, the submitted data shall be archived by the drug circulation-licensing agency like data which need not be secured.
Chapter IV HANDLING OF VIOLATIONS

Article 12.- Handling of violations

Organizations or individuals that violate the provisions of this Regulation shall, depending on the severity of their violations, be disciplined, administratively sanctioned or examined for penal liability in accordance with law.
Minister of Health

TRAN THI TRUNG CHIEN

Legislación Promulga (1 texto(s)) Promulga (1 texto(s)) Es derogado por (1 texto(s)) Es derogado por (1 texto(s)) Referencia del documento de la OMC
IP/N/1/VNM/U/1
IP/N/1/VNM/U/1 (p. 3-6)
Datos no disponibles.

N° WIPO Lex VN014