Circular No. 12/2022/TT-BYT dated November 21st, 2022 of the Ministry of Health on amendments to some Articles of the Circular No. 35/2018/TT-BYT dated November 22, 2018 of the Minister of Health prescribing Good Manufacturing Practices for pharmaceutical products and pharmaceutical starting materials

This Circular amends, supplements to principles to apply Good Manufacturing Practices (GMP) standards for manufacture of pharmaceutical products and pharmaceutical starting materials to the following cases

- Manufacturers of herbal pharmaceutical materials;

- Manufacturers of traditional pharmaceutical products in the form of powders, medicinal liquor or tinctures;

- Manufacturers of traditional pharmaceutical products and prepared traditional pharmaceutical materials;

- Manufacturers of anti-cancer drugs, sex hormones and highly active pharmaceutical ingredients;

- Manufacturers of chemical pharmaceutical products in the form of soft capsules, oral liquids and external medicines from herbal extract.

In addition, this Circular also amends regulations on documents used during the inspection of GMP compliance; periodic inspection of GMP compliance; procedures for reporting on changing, adding applied GMP principles; validity period of certificate of GMP compliance in the event of a disaster, disease, etc.

This Circular takes effect from January 5th, 2023.