Amendments of the procedures for renewal of the Traditional Medicine and Herbal Material Registration Certificate in Vietnam from January 1, 2025

Amendments of the procedures for renewal of the Traditional Medicine and Herbal Material Registration Certificate in Vietnam from January 1, 2025

The procedures for renewal of the Traditional Medicine and Herbal Material Registration Certificate in Vietnam are carried out as follows:

- Within 12 months before the registration expires, the registration entity submits one set of documents requesting the extension of the registration for traditional medicine and herbal medicine (extension documents) as regulated in Article 27 of Circular 21/2018/TT-BYT to the Department of Traditional Medicine and Pharmacy Management - Ministry of Health, either directly or via the online public service system. If the entity fails to submit the extension request within this timeframe, it must complete the registration procedure according to the regulations in Article 29 of Circular 21/2018/TT-BYT.

- Upon receiving a complete extension dossier, the Department of Traditional Medicine and Pharmacy Management provides the registration entity with a Receipt Note according to Form No. 02A issued with Circular 54/2024/TT-BYT. If the dossier is incomplete, the department will issue a document or request (in case of direct submission) for the registration entity to supplement the dossier adequately.

- A registration document that has expired but has been processed for extension by the Department of Traditional Medicine and Pharmacy Management may continue to be used until it is extended or otherwise notified as non-extendable or suspended due to safety concerns or suspected document forgery.

- The extension of registration is based on dossier appraisal and advice from the Council in cases where traditional medicine and herbal medicine breach the first-level quality standard as per Circular 38/2021/TT-BYT.

- Within a maximum of 3 months from the date of receiving a complete dossier, the Department of Traditional Medicine and Pharmacy Management will issue a document agreeing or disagreeing with the extension of registration for traditional medicines as regulated in clause 4, Article 30 of Circular 21/2018/TT-BYT (amended in clause 4, Article 1 of Circular 54/2024/TT-BYT) or if the traditional medicine or herbal medicine is suspected of document forgery. The procedure follows the provisions of clause 5, Article 21 of Circular 21/2018/TT-BYT.

- The extension of registration without requiring appraisal and Council advice applies to cases not falling under the provision in clause 4, Article 30 of Circular 21/2018/TT-BYT (amended in clause 4, Article 1 of Circular 54/2024/TT-BYT).

Within 3 months from the date of receiving a complete dossier, the Department of Traditional Medicine and Pharmacy Management will issue a document agreeing or disagreeing with the extension. The procedure follows the provisions of clause 6, Article 21 of Circular 21/2018/TT-BYT.

More details can be found in Circular 54/2024/TT-BYT effective from January 1, 2025.

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