Vietnam: Annual inspection and assessment of conformity to traditional drug processing standards

According to the Circular No. 32/2020/TT-BYT of the Health Ministry of Vietnam, in November of every year, authorities receiving declaration applications shall announce their plans for inspection and assessment of maintenance of conformity to traditional drug processing and preparation standards on their websites and send these plans to the establishments mentioned therein.

At least 30 days before the date of conformity inspection, the inspected establishments must send a report on traditional drug processing and/or preparation activities to the Ministry of Health or the Department of Health managing that establishment. Establishments failing to submit a report on their traditional drug processing and/or preparation activities shall be subject to an ad hoc inspection of their traditional drug processing and/or preparation activities by receiving authorities.

- If the conformity inspection results of an establishment are rated Level 1, the establishment may continue to process and/or prepare traditional drugs;

-  If the conformity inspection results of an establishment are rated Level 2 and the establishment has any serious issue, the receiving authority shall request the establishment to address the issue in writing.

- If the conformity inspection results of an establishment are rated Level 3 and the establishment has any critical issue, the receiving authority shall revoke the declaration published on its website and handle according to regulations in the Government’s Decree No. 117/2020/ND-CP.

More details at the Circular No. 32/2020/TT-BYT of the Health Ministry of Vietnam, effective from February 17, 2021.

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