Circular No. 16/2023/TT-BYT about marketing authorization registration of contract manufactured medicine, medicine of technology transfer in Vietnam

This circular prescribes marketing authorization registration of contract manufactured medicine, medicine of technology transfer in Vietnam; application and procedures for issuance, extension, revision, addition, and revocation of marketing authorization of contract manufactured medicine, medicine of technology transfer (pharmaceutics, vaccine, biologicals, herbal medicine) in Vietnam.

This is the legal foundation for attracting investment activities and transferring drug production technology, particularly for original brand-name medications, patented drugs, specialty drugs, special treatment drugs, generic drugs, high-tech dosage forms, vaccines, and biological products.

In addition, this circular provides regulations for shortening procedures for administration and application wait times and giving domestic drug manufacturers access to advanced and modern drug production processes, technologies, and techniques.

This circular goes into effect on October 1, 2023, and replaces Circular No. 23/2013/TT-BYT dated August 13, 2013, about guidance on drug processing activities.

REFERENCES:

Circular No. 16/2023/TT-BYT about marketing authorization registration of contract manufactured medicine, medicine of technology transfer in Vietnam