Legal Counselling

Application for issuance of a GMP Certificate for veterinary drugs in Vietnam

14:22, 05/09/2016

The Government of Vietnam issued Decree No. 35/2016/ND-CP on guidelines for the Law on veterinary medicine.

Specifically, according to Decree No. 35/2016/ND-CP of Vietnam’s Government, an application for issuance of a GMP Certificate for veterinary drugs (hereinafter referred to as GMP Certificate) includes:

- An application form for GMP inspection;

- A Certificate of Enterprise registration;

- A chart of organization and personnel of the manufacturer;

- Programs, training materials and evaluation of training results pertaining to GMP at the manufacturer;

- A list of manufacturing, storing and quality-inspecting equipment;

- A list of standard operating procedures;

- A list of products being manufactured or to be manufactured;

- A report on environmental impact assessment approved by an environment authority;

- A minutes of GMP self-inspection;

- Any new manufacturer applying for GMP inspection shall also submit manufacturing practice certificates of the employees in charge of technical matters and veterinary testing laboratory.

Decree No. 35/2016/ND-CP of Vietnam’s Government takes effect from July 01, 2016.

- Thanh Lam -

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