Hanoi-Vietnam: Retention period for documents on registration and marketing authorization of traditional medicines is 20 years

This is stipulated in Circular 53/2017/TT-BYT regulating the retention periods of documents and professional materials of the healthcare sector in Vietnam.

According to the provisions of Circular 53, the documents on traditional medicine and pharmaceuticals in Vietnam must be retained for the following periods:

No. Name of documents Retention period
1 Documents on monitoring the application of traditional medicine in community healthcare Permanent
2 Documents on management and monitoring activities of traditional medicine and pharmaceutical establishments 50 years
3 Documents on supply, processing, preparation, and use of traditional medicine in medical examination and treatment 20 years
4 Documents on cultivation, harvesting, exploitation, and processing of medicinal herbs 70 years
5 Documents on the preservation of medicinal herbs, quality of medicinal herbs 70 years
6 Documents on registration, circulation, and recall of traditional medicine 20 years
7 Documents on clinical trials of traditional medicine before circulation 20 years
8 Documents on issuing, reissuing practicing certificates for medical examination and treatment with traditional medicine, issuing, reissuing, adjusting, and revoking certificates of family traditional medicine recipes 20 years
9 Documents on granting operation permits to medical examination and treatment establishments using traditional medicine according to legal regulations 20 years
10 Documents on appraising the professional content of advertising registration for medical examination and treatment activities using traditional medicine 10 years

More details can be found in Circular 53/2017/TT-BYT effective from February 15, 2018.

- Thanh Lam -

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