Hanoi-Vietnam: Retention period for documents for issuance and reissuance of pharmacy practice certificates is 50 Years

06:29, 11/07/2024

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

According to Circular 53, the group of documents related to medical examination, treatment, and rehabilitation in Vietnam must be retained for the following periods:

No.	Name of documents	Retention period
	Group 01. Documents on medical examination, treatment, and rehabilitation
…	…	…
1	Documents on organizing medicine information and pharmacovigilance activities	70 years
2	Documents on supplying, preserving, distributing, and using medicines	70 years
3	Documents on issuing and reissuing pharmacy practice certificates	50 years
4	Documents on medicine production and preparation in medical examination and treatment facilities	50 years
5	Documents on clinical medicine trials and bioequivalence trials of medicines	50 years
6	Documents on handling medicine and cosmetic safety warning information	50 years
7	Documents on medicine and cosmetic registration number appraisal	30 years
8	Documents on medicine and cosmetic testing; medicine ingredients, and packaging in direct contact with medicines	20 years
9	Documents on issuing and revoking certificates of compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Storage Practice (GSP), and good practices in pharmaceutical packaging production	20 years
10	Documents on directing and implementing medicine business management for traditional medicine and herbal medicine (including activities: production, quality inspection, storage, circulation, distribution, and import-export)	20 years
…	…	…

Full retention periods may be found in Circular 53/2017/TT-BYT effective from February 15, 2018.

- Thanh Lam -

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