Vietnam: Handling traditional drugs failing to meet quality standards

According to Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam, handling traditional drugs failing to meet quality standards is specified as follows:

1. With regard to samples of traditional drugs taken by a quality inspection agency at a retailer or Class-III or Class-IV health facility:

- Within 24 hours from the receipt of testing report or analytical report given by the testing facility, the Provincial Department of Health shall seal traditional drugs failing to meet quality standards at the establishment where such samples are taken;

- Within 48 hours from the receipt of testing report or analytical report given by the testing facility, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall request the applicant for registration, the manufacturer or importer in writing to:

+ Send report on distribution of traditional drugs to the Ministry of Health (via the Traditional Medicine Administration of Vietnam);

+ Request the quality inspection agency to take additional samples of traditional drugs at the domestic manufacturer or importer and wholesaler;

+ Send samples taken to a central-level testing facility for testing unsatisfactory quality indices.

- When there is an additional sample of traditional drugs fails to meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the violation degree and reach a conclusion about recall of traditional drugs according to regulations in the Appendix II enclosed herewith, and issue a decision on recall of traditional drugs;

- If the testing result shows that additional samples of traditional drugs meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall only determine the violation degree, reach a conclusion and issue decision on recall of traditional drugs of the establishment where initial samples are taken.

2. With regard to samples of traditional drugs taken by a quality inspection agency at a wholesaler or a health facility of Class II or higher class:

- Within 24 hours from the receipt of testing report or analytical report given by the testing facility, the Provincial Department of Health shall seal traditional drugs failing to meet quality standards at the establishment where such samples are taken;

- Within 48 hours from the receipt of testing report or analytical report given by the testing facility, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall issue a decision on recall of traditional drugs sold in the province or central-affiliated city where samples are taken and request the applicant for registration, the manufacturer or importer in writing to:

+ Send report on distribution of traditional drugs to the Ministry of Health (via the Traditional Medicine Administration of Vietnam);

+ Request the quality inspection agency to additionally take at least 02 samples of traditional drugs of other wholesalers;

+ Send samples taken to a central-level testing facility for testing unsatisfactory quality indices.

- When there is an additional sample of traditional drugs fails to meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall determine the violation degree and reach a conclusion about recall of traditional drugs according to regulations in the Appendix II enclosed herewith, and issue a decision on nationwide recall of traditional drugs;

- If the testing result shows that additional samples of traditional drugs meet quality standards, the Ministry of Health (via the Traditional Medicine Administration of Vietnam) shall only determine the violation degree, reach a conclusion and issue decision on recall of traditional drugs sold in the province or central-affiliated city where samples are taken to the establishment where initial samples are taken.

Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam takes effect from June 30, 2018, replacing Decree No. 05/2014/TT-BYT.

- Thanh Lam -

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