Vietnam: Where to submit the application for recognition of GMP compliance?

08:59, 04/01/2019

On November 22, 2018, the Ministry of Health of Vietnam issued Circular No. 35/2018/TT-BYT on Good Manufacturing Practices (GMP) for pharmaceutical products and pharmaceutical starting materials.

According to Circular No. 35/2018/TT-BYT of the Ministry of Health of Vietnam, in order to be recognized for GMP compliance, the manufacturer shall submit an application to:

- the Traditional Medicine Administration of Vietnam if the manufacturer applies for the certificate for eligibility for pharmacy business that allows manufacture of herbal materials, traditional pharmaceutical products and prepared traditional medicinal materials at the time of submission;

- the Drug Administration of Vietnam if the manufacturer applies for the certificate for eligibility for pharmacy business that allows manufacture of pharmaceutical starting materials (excluding herbal materials), chemical pharmaceutical products, herbal pharmaceutical products, vaccines and biologicals;

- the Drug Administration of Vietnam if the manufacturer applies for the certificate for eligibility for pharmacy business that allows manufacture of both one of the pharmaceutical products and pharmaceutical starting materials and one of the pharmaceutical products and pharmaceutical starting materials at the time of submission.

View more details at Circular No. 35/2018/TT-BYT of the Ministry of Health of Vietnam, effective from January 10, 2019.

- Thanh Lam -

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