List of poisonous medicinal ingredients in Vietnam from October 10, 2024

List of poisonous medicinal ingredients in Vietnam from October 10, 2024 (Image from the Internet)

On August 26, 2024, the Minister of Health issued Circular 13/2024/TT-BYT regarding the List of poisonous medicinal ingredients in Vietnam.

List of poisonous medicinal ingredients in Vietnam from October 10, 2024

Poisonous medicinal ingredients are explicitly listed in the following categories:

- List of poisonous medicinal ingredients of plant origin as stipulated in Appendix I attached to Circular 13/2024/TT-BYT:

- List of poisonous medicinal ingredient of animal origin as stipulated in Appendix II attached to Circular 13/2024/TT-BYT:

- List of poisonous medicinal ingredient of mineral origin as stipulated in Appendix III attached to Circular 13/2024/TT-BYT:

Note:

- The list of poisonous medicinal ingredient is the basis for state management agencies to implement regulations on the management of poisonous medicinal ingredient in business, registration, labeling, prescription, distribution, processing, storage, use, inspection, handling violations, and other related activities.

- Medicinal herbs marked (*) in the Appendices attached to Circular 13/2024/TT-BYT must be processed according to the processing methods stipulated in Circular 30/2017/TT-BYT guiding the methods for processing traditional medicines or the Vietnamese Pharmacopoeia or Pharmacopoeias of other countries.

- Medicinal herbs marked (**) used for external purposes are not required to follow the processing methods stipulated in Circular 30/2017/TT-BYT guiding the methods for processing traditional medicines.

More details can be found in Circular 13/2024/TT-BYT, effective from October 10, 2024.

If the medicinal product contains ingredients from the List of poisonous medicinal ingredients in Vietnam and was granted a Marketing Authorization before Circular 13/2024/TT-BYT becomes effective, the production and business establishments of medicinal herbs, traditional medicines, herbal medicines must classify, update, and supplement the labeling information and instructions related to toxic medicinal herb classification as prescribed in Circular 13/2024/TT-BYT by December 31, 2026.

If the medicinal product contains ingredients from the List of poisonous medicinal ingredients in Vietnam applied for Marketing Authorization before Circular 13/2024/TT-BYT becomes effective but has not yet been granted, the competent authority will consider granting Marketing Authorization under current regulations, with toxic medicinal herb classification still applied according to Circular 42/2017/TT-BYT issuing the list of poisonous medicinal ingredient; except for voluntary compliance with Circular 13/2024/TT-BYT.

If the medicinal product contains ingredients from the List of poisonous medicinal ingredients in Vietnam applied for Marketing Authorization according to Clause 2 Article 6 Circular 13/2024/TT-BYT but has not voluntarily complied with Circular 13/2024/TT-BYT and has been granted Marketing Authorization; within a maximum period of 2 years from the date of Marketing Authorization, the production and business establishments of medicinal herbs, traditional medicines, herbal medicines must supplement the labeling information and instructions related to toxic medicinal herb classification as prescribed in Circular 13/2024/TT-BYT.

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