Vietnam: Manufacturers of drugs may change the authorization holder within 30 days

Currently, “applicant” or “authorization holder” means the establishment that applies for the marketing authorization, renewal or revision thereof.

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According to Article 4 of Circular No. 32/2018/TT-BYT of the Ministry of Health of Vietnam, manufacturers of drugs/medicinal ingredients shall have the responsibility to follow procedures for changing the authorization holder within 30 days from the day on which Drug Administration of Vietnam signs the notice that the current authorization holder is no longer qualified for operation.

In addition to the above responsibility, manufacturers of drugs/medicinal ingredients shall also:

- Manufacture the drugs/medicinal ingredients at the factory having the manufacture license issued by a competent authority.

- Request revocation of the marketing authorization in case the drug/medicinal ingredient may affect users’ health in terms of their quality, safety or efficacy (Form No. 1/TT enclosed herewith)

- Cooperate with the applicant/authorization holder in implementation of Clause 1, 2, 3 Article 3 of this Circular.

- Cooperate with the applicant/authorization holder in fulfilling competent authorities’ request for inspection or evaluation of the manufacturing facility.

- Maintain the operating conditions of the manufacturing facility throughout the effective period of the marketing authorization.

- Update specifications of drugs/medicinal ingredients in accordance with Circular No. 11/2018/TT-BYT.

Other provisions can be found in Circular No. 32/2018/TT-BYT of the Ministry of Health of Vietnam, which takes effect from September 01, 2019.

Thu Ba

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