Long marketing authorisation for pharmaceutical products in affecting UK exporters in Vietnam
in VietnamTrade barrier summary
Updated January 2021: Circular 29 has been passed by the Vietnamese and came into effect on 1 January 2021. This secures the following:
A 12-month extension of Marketing Authorisation for pharmaceutical products expired before 31/12/2021;
Deferral of some of the requirements for the Certificate of Pharmaceutical Product (CPP);
Allows flexibility for legal documents during the COVID-19 pandemic.
The barrier is therefore partially resolved, although not entirely removed.
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This trade barrier started in April 2020. There has been a period of transferring from old and new circulars guiding drug registration. Pharmaceutical products being submitted to seek authorisation for a five-year extension for marketing a product - seem to be being processed slowly at the Drug Administration of Vietnam (DAV), the Ministry of Health (MOH). The MOH allows ad-hoc extension for 12 months for those drugs and vaccines that have a licence that expired before the 20th June 2020. However, there are a large number of drugs and vaccines from pharmaceuticals businesses that are expected to expire between the 1st July 2020 to the 20th June 2021, risking these products not being able to be exported to Vietnam.
Sectors affected
- Pharmaceuticals and biotechnology
Resolved
No
Date reported
27 May 2020
Last updated
2 November 2022
Public ID
PID-YB8AAB
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