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.
Notably, according to clause 2 Article 6, with regard to contract manufactured medicine whose contract production stages in Vietnam follow a roadmap, applicants or contract facilities implement contract manufacturing of medicine must file report on contract manufacturing progress of production stages of finished products in Vietnam to the Ministry of Health (via the Drug Administration of Vietnam) using Form No. 04/TT under Appendix 1 attached hereto on an annual basis from the date on which marketing authorization is issued.
And under clause 2 Article 10, with regard to medicine of technology transfer whose production stages in Vietnam follow a roadmap, applicants or receiving facilities implement technology transfer of medicine must file report on technology transfer progress of production stages of finished products in Vietnam to the Ministry of Health (via the Drug Administration of Vietnam) using Form No. 04/TT under Appendix 1 attached hereto on an annual basis from the date on which marketing authorization is issued.
In case of failing to report on contract manufacturing progress (with regard to contract manufactured medicine) or technology transfer progress (with regard to medicine of technology transfer) according to the aforesaid regulations, the Drug Administration of Vietnam shall consider temporary suspension or revocation of medication declaration.
This Circular takes effect from October 1st, 2023 and replaces Circular No. 23/2013/TT-BYT
dated August 13th, 2013.
Quy định mới về đăng ký lưu hành thuốc gia công, thuốc chuyển giao công nghệ 
