MINISTRY OF HEALTH
Circular No. 32/2018/TT-BYT dated November 12, 2018 of the Ministry of Health on marketing authorization of drugs and medicinal ingredients
Pursuant to the Law on Pharmacy April 06, 2016;
Pursuant to the Government's Decree No. 54/2017/ND-CP dated May 08, 2017 on elaboration of the Law on Pharmacy;
Pursuant to the Government's Decree No. 75/2017/ND-CP dated June 20, 2017 defining functions, tasks, entitlements and organizational structure of the Ministry of Health;
Pursuant to the Government's Decree No. 155/2018/ND-CP dated November 12, 2018 amending some regulations on conditions for doing business under management of the Ministry of Health;
At the request of the Director of the Drug administration of Vietnam,
The Minister of Health promulgates a Circular on marketing authorization of drugs and medicinal ingredients
Article 1. Scope of regulation
1. This Circular provides for:
a) Documents procedures for issuance, renewal, revision and revocation of the marketing authorization (also called licensing, registration, approval, etc.) of modern medicines, vaccines, biologicals, herbal ingredients and medicinal ingredients (active ingredients, semi-finished herbal ingredients, excipients, capsule shells) for human use in Vietnam;
b) Required clinical data for assurance of safety and efficacy in the application;
c) Requirements for exemption from clinical trial or certain stages thereof in Vietnam; drugs that have to undergo Stage 4 clinical trial;
d) Rules for validating applications for the marketing authorization of drug/medicinal ingredient (hereinafter referred to as “marketing application”), renewal and revision thereof;
dd) Rules for validating applications for the license to import drugs that are yet to be approved for marketing authorization (hereinafter referred to as “unapproved drugs”) in the cases specified in Point a Clause 43 Article 5 of Decree No. 155/2018/ND-CP;
e) Rules for organization and operation of Marketing Authorization Advisory Board (hereinafter referred to as “the Advisory Board”);
g) Procedures for validating marketing applications, renewal and revision thereof; application for the license to import unapproved drugs.
2. This Circular does not apply to the cases mentioned in Clause 2 Article 54 of the Law on Pharmacy, which provides for medicinal ingredients that are not required to be registered before marketing authorization in Vietnam, and semi-finished herbal ingredients produced by the same producer of the drug products.
Article 2. Definitions
For the purpose of this Circular, the terms below are construed as follows:
1. ASEAN common technical dossier (ACTD) means the document providing guidelines for registration of drugs that satisfy ASEAN Common Technical Requirements (ACTR), which are specified in Appendix I hereof.
2. ICH-CTD means the common technical document provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
3. “Major variations” are variations that clearly and directly affect the quality, safety and efficacy of the drug, specified in Appendix II hereof.
4. “”Minor variations” are variations that do not affect or barely affect the quality, safety and efficacy of the drug, specified in Appendix II hereof.
5. “Applicant” or “authorization holder” means the establishment that applies for the marketing authorization, renewal or revision thereof.
6. “Manufacturer” means the establishment that carry out one or some or all of the manufacturing processes or release of the batch of drug.
7. “Ingredient manufacturer” means the establishment that manufactures or releases the ingredient(s) of the drug product.
8. “Product license holder” or “product owner” of a foreign drug means the establishment responsible for the drug product and is written on the Certificate of pharmaceutical product (CPP).
9. “Reference authorities” mentioned in this Circular include: European Medicines Agency (EMA), drug regulatory authorities of the USA, Japan, France, Germany, Sweden, England, Switzerland, Australia, Canada, Belgium, Austria, Ireland, Denmark and Netherland
10. Stringent Regulatory Authorities (SRA) area drug regulatory authorities that are considered SRA by WHO. A SRA is:
a) A member of ICH before October 23, 2015, including: US-FDA, drug regulatory authorities of European Commission, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Pharmaceuticals Medical Devices Agency (PMDA);
b) AN ICH observers before October 23, 2015, including: European Free Trade Association (EFTA), Swissmedic and Health Canada;
c) A regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement before October 23, 2015, including: Australia, Iceland, Liechtenstein and Norway.
11. “Certificate of pharmaceutical product (CPP)” means a certificate issued in the format recommended by WHO according to WHO’s Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.
12. “Semi-finished herbal ingredients” are medicinal ingredients derived from herbs in the form of glue, granule, powder, extract, essential oil, resin, gum, jelly.
Article 3. Responsibilities of applicants/authorization holders
1. Take responsibility for any revision to the label or package insert; comply with update request of the Ministry of Health (Drug Administration of Vietnam) during the effective period of the marketing authorization without having to submit an application for revision.
2. Apply for revision according to Clause 4 Article 28 and Article 40 of this Circular during effective period of the marketing authorization.
3. Ensure quality, safety and efficacy of the drugs/medicinal ingredients as declared in the application.
4. Take responsibility for legitimacy and accuracy of every document in the application. Cooperate with the foreign authority and manufacturer in responding to inquiries of Drug administration of Vietnam regarding the authenticity of legal documents in the application.
5. Send a written notice to Drug Administration of Vietnam within 30 days from the day on which the marketing authorization is revoked in any country if the drugs/medicinal ingredients have been granted the marketing authorization in Vietnam, and specify the reason for such revocation.
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