New Text Notification

Vietnam: New regulations on registration of circulation for medicine and medicinal ingredients

Lê Trương Quốc Đạt

17:40, 08/09/2022

On September 5, 2022, the Minister of Health of Vietnam issued Circular 08/2022/TT-BYT on the registration of circulation for medicine and medicinal ingredients.

Vietnam's Circular 08/2022/TT-BYT elaborates the following contents:

- Procedures for granting, extending, changing, or supplementing the medicine circulation registration certificate;

- Criteria for determining cases of exemption from trial or some phases of clinical trial;

- Principles of organization and operation of appraisal experts on licensing the import of medicine without circulation registration certificates,...

Vietnam's Circular 08/2022/TT-BYT takes effect from October 20, 2022.

At the same time, regulations on the transition of some contents on the registration of the circulation of drugs and medicinal ingredients are as follows:

- Application submitted before Vietnam's Circular 08/2022/TT-BYT takes effect may continue to apply the regulations at the time of application submission;

- The registration of circulation of Covid-19 vaccines in urgent cases shall follow Vietnam's Circular 11/2021/TT-BYT;...

More details can be found in Vietnam's Circular 08/2022/TT-BYT.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE

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