Vietnam: Updating quality standards and application of updated pharmacopoeia

According to Circular No. 13/2018/TT-BYT of the Ministry of Health of Vietnam, establishments trading in herbal ingredients/ traditional drugs must updated quality standards applicable to herbal ingredients/ traditional drugs and apply updated pharmacopeia in a timely manner as follows:

- With regard to herbal ingredients in the list of herbal ingredients to be registered and traditional drugs: When submitting application for registration or renewal of certificate of free sale of herbal ingredients/ traditional drugs, quality standards including in such applications must fulfill relevant requirements in the current version of the pharmacopoeia or its previous version which has been offered for not more than 02 years by the effective date of the current version.

- With regard to herbal ingredients in the list of herbal ingredients to be registered and traditional drugs granted certificate of free sale: Within a period of 02 years from the release of the latest version of the pharmacopoeia, manufacturers or applicants for registration of herbal ingredients/ traditional drugs shall update quality standards for herbal ingredients/ traditional drugs specified in such pharmacopoeia’s latest version.

- With regard to herbal ingredients which are not in the list of herbal ingredients to be registered: Within a period of 01 year from the release of the latest version of the pharmacopoeia, manufacturers, importers and distributors of herbal ingredients shall update quality standards for herbal ingredients specified in such pharmacopoeia’s latest version and re-make declaration of applicable quality standards.

- When manufacturers or applicants find out any elements causing adverse effects on the quality, safety and efficiency of their herbal ingredients/ traditional drugs or at the request of the Ministry of Health (via the Traditional Medicine Administration of Vietnam), manufacturers must update quality standards for monitoring such elements and re-make declaration of applicable quality standards in case a herbal ingredient is not in the list of herbal ingredients to be registered.

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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