Additional requirements for pharmaceuticals registration in Vietnam affecting UK exporters
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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In the draft 'circular' for pharmaceuticals registration issued in Vietnam, there is an additional requirement.
When registering pharmaceuticals, a Certificate of Pharmaceutical Product (CPP) is required, which needs to list the source of each ingredient used in the final product.
This additional requirement causes 2 main challenges for overseas businesses:
1. The CPP needs to be completed by the pharmaceutical authorities of the manufacturing countries - most pharmaceuticals authorities use the World Health Organisation (WHO) CPP template, which does not need information on the source of ingredients.
2. It may place an additional burden for overseas businesses to provide the relevant information for each pharmaceutical.
Sectors affected
- Pharmaceuticals and biotechnology
- Pharmaceuticals and biotechnology
Resolved
Yes - September 2022
Date reported
1 April 2019
Last updated
2 November 2022
Public ID
PID-EGRLYG
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