On August 26, 2024, the Minister of Health issued Circular 13/2024/TT-BYT promulgating the List of poisonous medicinal ingredients in Vietnam.
The Ministry of Health has stipulated the principles for developing, criteria for selecting medicinal ingredients into the List of poisonous medicinal ingredients, and issued the List of Toxic Medicinal Ingredients of plant, animal, and mineral origin.
* Principles of development and criteria for selecting medicinal ingredients into the List of poisonous medicinal ingredients in Vietnam
(1) Principles for developing the List of poisonous medicinal ingredients:
- Harmonize with the guidelines of countries in the region and around the world regarding the classification of poisonous medicinal ingredients;
- Align with the global database on poisonous medicinal ingredients;
- Inherit the previously issued List of poisonous medicinal ingredients.
(2) Criteria for selecting medicinal ingredients into the List of poisonous medicinal ingredients:
A medicinal ingredient is considered for inclusion in the List of poisonous medicinal ingredients when it meets one of the following criteria:
- The medicinal ingredient is documented in the Vietnamese Pharmacopoeia or the pharmacopoeias of other countries worldwide, which include information on the toxicity, extreme toxicity (except in cases of minor toxicity);
- The medicinal ingredient possesses high toxicity that adversely affects the health and life of users;
- The medicinal ingredient, during its usage, causes known serious adverse reactions or is recommended by the World Health Organization, a competent authority in Vietnam, or a competent authority in a foreign country.
(Article 2 of Circular 13/2024/TT-BYT)
* Issuing the List of poisonous medicinal ingredients in Vietnam
Issued along with Circular 13/2024/TT-BYT includes the following lists of poisonous medicinal ingredients:
(1) List of toxic medicinal ingredients of plant origin stipulated in Appendix I issued with Circular 13/2024/TT-BYT.
(2) List of toxic medicinal ingredients of animal origin stipulated in Appendix II issued with Circular 13/2024/TT-BYT.
(3) List of toxic medicinal ingredients of mineral origin stipulated in Appendix III issued with Circular 13/2024/TT-BYT.
More details can be found in Circular 13/2024/TT-BYT which comes into force in Vietnam from October 10, 2024.
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