On November 21, 2022, the Ministry of Health issues Circular No. 12/2022/TT-BYT on amending and supplementing a number of articles of the Minister of Health's Circular No. 35/2018/TT-BYT dated November 22, 2018, on good practices of manufacturing drugs or drug materials.
Accordingly, the document GMP principles and standards prescribed in Clause 4, Article 3 is amended and supplemented as follows: In the case where the World Health Organization amends and supplements the principles or standards for good practices of manufacturing drugs or drug materials, within 03 months from the date on which the updated documents are publicized on the World Health Organization’s portal, the Drug Administration of Vietnam or the Traditional Medicine Administration shall, within the state management, organize to translate and publicize such amendments and supplementations on the Ministry of Health's portal and its website, for search, update and application.....
Besides, If the drug or drug material manufacturing establishment has one of the changes prescribed at Points dd, e or g Clause 2, Article 11 of Circular No. 35/2018/TT-BYT, it is required to submit a report on its changes, accompanied by relevant technical documents, to the receiving agency. Besides, the manufacturer must maintain its operations in compliance with GMP standards and principles.
Additionally, manufacturers granted a GMP certificate with the scope of manufacturing drugs from medicinal materials that remains valid before the effective date of this Circular are entitled to manufacture traditional drugs.
This Circular takes effect on January 05, 2023.