Guidance on the methods of processing of herbal ingredients and traditional drug ingredients in Vietnam from October 28, 2024 is available

Guidance on the methods of processing of herbal ingredients and traditional drug ingredients in Vietnam from October 28, 2024 is available (Image from the Internet)

On September 06, 2024, the Minister of Health issued Circular 14/2024/TT-BYT guiding methods for processing of herbal ingredients and traditional drug ingredients.

Guidance on the methods of processing of herbal ingredients and traditional drug ingredients in Vietnam from October 28, 2024 is available

Circular 14/2024/TT-BYT guides methods for processing of herbal ingredients and traditional drug ingredients at traditional medicine clinics, establishments producing, trading herbal medicines, traditional drug ingredients, and medicinal drugs.

The Ministry of Health of Vietnam has issued methods for processing of herbal ingredients and traditional drug ingredients including:

- General methods for processing of herbal ingredients and traditional drug ingredients are specified in Appendix I, issued with Circular 14/2024/TT-BYT.

- Specific processing methods for certain traditional drug ingredients in Appendix II, issued with Circular 14/2024/TT-BYT.

Regarding the guidelines for using methods to process herbal medicines and traditional drug ingredients:

- The methods for processing of herbal ingredients and traditional drug ingredients issued with Circular 14/2024/TT-BYT serve as a basis for establishments to develop their own herbal medicine and traditional remedy production processes.

- If an establishment uses a processing method not included in or not specified in Appendix II issued with Circular 14/2024/TT-BYT, the establishment should refer to the methods documented in the Vietnamese Pharmacopeia, pharmacopeias worldwide, or textbooks for pharmacists and traditional medicine doctors to develop their processing methods for herbal medicines and traditional drug ingredients and bear full legal responsibility for the quality, safety, and efficacy of the products post-processing.

More details can be found in Circular 14/2024/TT-BYT,which comes into force in Vietnam from October 28, 2024.

Batches of traditional drug ingredients already produced according to Registration Certificates issued before Circular 14/2024/TT-BYT takes effect can continue to circulate until their expiration date, as per regulations, including those processed differently from methods specified in Circular 14/2024/TT-BYT.

Traditional drug ingredients that received Registration Certificates before the effective date of Circular 14/2024/TT-BYT but are processed differently from methods specified in Circular 14/2024/TT-BYT; the registration establishments must update, amend, and supplement formulas, production processes, and related information within a maximum of 2 years from the date of issuance of the Registration Certificate or by December 31, 2026.

If applications for registration certificates for traditional drug ingredients were submitted before this Circular takes effect but have not yet been issued, the competent authority will review and issue Registration Certificates according to the regulations, following processing methods specified in Circular 30/2017/TT-BYT guiding methods for processing traditional drug ingredients, unless the establishment voluntarily complies with Circular 14/2024/TT-BYT.

For traditional drug ingredients submitting registration documents according to Clause 3, Article 6 of Circular 14/2024/TT-BYT but not voluntarily complying with Circular 14/2024/TT-BYT and receiving Registration Certificates, the establishment must update, amend, and supplement formulas, production processes, and related information in the registration dossier according to regulations within a maximum of 2 years from the date of issuance of the Registration Certificate.

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