What are rights and responsibilities of vaccine manufacturing facilities in Vietnam?

What are rights and responsibilities of vaccine manufacturing facilities in Vietnam? - image from internet

Pursuant to Clause 2 Article 3 of the Circular 11/2021/TT-BYT stipulating following regulations:

Vaccine manufacturing facilities (hereinafter referred to as “manufacturing facilities”) shall have the rights and responsibilities mentioned in Article 43 of the Law on Pharmacy and Article 4 of Circular 32/2018/TT-BYT.

Pursuant to Article 43 of the Law on Pharmacy in 2016 and Article 4 of the Circular 32/2018/TT-BYT stipulating following regulations:

1. A manufacturer of drugs/medicinal ingredients has the following rights:

a) The rights specified in Clause 1 Article 42 hereof;

b) Research, carry out pilot production; manufacture drugs/medicinal ingredients; grant and acquire franchise for drug manufacture; process drugs/medicinal ingredients;

c) Register drugs/medicinal ingredients; transfer certificates of free sale; request revocation of certificates of free sale of drugs/medicinal ingredients it manufactures; request recall of drugs/medicinal ingredients in accordance with this Law;

d) Import, purchase medicinal ingredients serving manufacture; import drugs/medicinal ingredients serving research, testing, or as samples for drug registration;

dd) Sell medicinal ingredients imported to serve manufacture of drugs to be sold to other drug manufacturers;

e) Sell drugs/medicinal ingredients wholesale to drug wholesalers, drug retailers, and health facilities;

g) Export drugs/medicinal ingredients specified in Clause 4 and Clause 5 Article 60 hereof.

2. A manufacturer of drugs/medicinal ingredients has the following obligations:

a) Relevant obligations specified in Points a, b, c, d, dd, e, g, h, i, k, l, m n of Clause 2 Article 42 hereof;

b) manufacture drugs/medicinal ingredients in accordance with the manufacturing process and quality standards registered or announced;

c) Take responsibility for the origin, quality of drugs/medicinal ingredients it manufactures; only allow the release of drugs/medicinal ingredients that meet the registered quality standards;

d) monitor the quality, safety, efficacy of drugs/medicinal ingredients it products while they are being sold on the market; recall drugs/medicinal ingredients in accordance with this Law;

dd) Take responsibility of the quantity of drugs/medicinal ingredients imported, traded, or used and prepare reports as prescribed by the Minister of Health.

Responsibilities of manufacturers of drugs/medicinal ingredients are stipulated as follows:

1. Manufacture the drugs/medicinal ingredients at the factory having the manufacture license issued by a competent authority.

2. Request revocation of the marketing authorization in case the drug/medicinal ingredient may affect users’ health in terms of their quality, safety or efficacy (Form No. 1/TT enclosed herewith)

3. Cooperate with the applicant/authorization holder in implementation of Clause 1, 2, 3 Article 3 of this Circular.

4. Cooperate with the applicant/authorization holder in fulfilling competent authorities’ request for inspection or evaluation of the manufacturing facility.

5. Maintain the operating conditions of the manufacturing facility throughout the effective period of the marketing authorization.

6. Follow procedures for changing the authorization holder within 30 days from the day on which Drug Administration of Vietnam signs the notice that the current authorization holder is no longer qualified for operation.

7. Update specifications of drugs/medicinal ingredients in accordance with Circular No. 11/2018/TT-BYT.

Best regards!