Circular 13/2024/TT-BYT on the List of Toxic Herbal Medicines issued by the Minister of Health

CIRCULAR

ISSUING THE LIST OF TOXIC DRUG RAW MATERIALS

Pursuant to the Medicine Law No. 105/2016/QH13 dated April 6, 2016;

Pursuant to the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law;

Pursuant to the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to the Decree No. 88/2023/NĐ-CP dated December 11, 2023 of the Government amending and supplementing certain provisions of the Decree No. 54/2017/NĐ-CP dated May 8, 2017 of the Government detailing some provisions and measures for implementing the Medicine Law and the Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government amending and supplementing certain regulations related to investment and business conditions within the scope of management of the Ministry of Health;

Pursuant to Decree No. 95/2022/NĐ-CP dated November 15, 2022 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Traditional Medicine Management Department,

The Minister of Health issues this Circular on issuing the List of Toxic Drug Raw Materials.

Article 1. Scope of Regulation

This Circular stipulates the principles for building and criteria for selecting raw materials into the List of Toxic Drug Raw Materials and promulgates the List of Toxic Drug Raw Materials from plant, animal, and mineral sources.

Article 2. Principles for Building and Criteria for Selecting Raw Materials into the List of Toxic Drug Raw Materials

1. Principles for Building the List of Toxic Drug Raw Materials:

a) In harmony with guidelines of countries in the region and worldwide regarding the classification of toxic drug raw materials;

b) Consistent with global databases on toxic drug raw materials;

c) Inheriting the previously issued List of Toxic Drug Raw Materials.

2. Criteria for Selecting Raw Materials into the List of Toxic Drug Raw Materials: Raw materials will be considered for inclusion in the List of Toxic Drug Raw Materials if they meet one of the following criteria:

a) Raw materials have monographs in the Vietnamese Pharmacopoeia or pharmacopoeias of other countries, which include information about their toxicity or extreme toxicity (except cases noted as low toxicity);

b) Raw materials have high toxicity that affects users' health and lives;

c) Raw materials cause serious adverse reactions during use, which have been known or recommended by the World Health Organization, competent authorities in Vietnam, or competent authorities in foreign countries.

Article 3. List of Toxic Drug Raw Materials

Attached to this Circular is the List of Toxic Drug Raw Materials including:

1. The List of Toxic Plant Raw Materials specified in Appendix I attached to this Circular.

2. The List of Toxic Animal Raw Materials specified in Appendix II attached to this Circular.

3. The List of Toxic Mineral Raw Materials specified in Appendix III attached to this Circular.

Article 4. Provisions on Using the List of Toxic Drug Raw Materials

1. The List of Toxic Drug Raw Materials serves as the basis for state management agencies to implement regulations on managing toxic raw materials in business, registration, labeling, prescription, distribution, processing, storage, use, inspection, supervision, violation handling, and other related activities.

2. Raw materials marked with (*) in the Appendices attached to this Circular must be processed according to the methods prescribed in Circular No. 30/2017/TT-BYT dated July 11, 2017 of the Minister of Health guiding the processing methods of traditional herbal medicines or the Vietnamese Pharmacopoeia or pharmacopoeias of other countries.

3. Raw materials marked with (**) when used externally are not required to follow the processing methods prescribed in Circular No. 30/2017/TT-BYT dated July 11, 2017 of the Minister of Health guiding the processing methods of traditional herbal medicines.

Article 5. Effective Date

1. This Circular takes effect from October 10, 2024.

2. Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Minister of Health promulgating the List of Toxic Drug Raw Materials ceases to be effective from the date this Circular takes effect.

Article 6. Transitional Provisions

1. For drugs containing components listed in the List of Toxic Drug Raw Materials that were granted a Registration Certificate before the effective date of this Circular, manufacturers and traders of traditional herbal medicines, traditional drugs, and herbal drugs must classify, update, and supplement relevant information on labels and usage instructions according to the provisions of this Circular, completing such actions by December 31, 2026.

2. For drugs containing components listed in the List of Toxic Drug Raw Materials that submitted applications for Registration Certificates before the effective date of this Circular but have not yet received them, competent authorities shall consider granting Registration Certificates according to current regulations, where the provisions on classifying toxic raw materials still apply as per Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Minister of Health promulgating the List of Toxic Drug Raw Materials, except in cases where the entity voluntarily complies with the provisions of this Circular.

3. For drugs containing components listed in the List of Toxic Drug Raw Materials that submitted applications for Registration Certificates according to Clause 2 of this Article but did not voluntarily comply with the provisions of this Circular and obtained Registration Certificates, within a maximum period of two years from the date of issuance of the Registration Certificate, manufacturers and traders of traditional herbal medicines, traditional drugs, and herbal drugs must supplement relevant information on labels and usage instructions according to the provisions of this Circular.

Article 7. Reference Provisions

In case the regulatory legal documents and provisions cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new regulatory legal documents.

Article 8. Responsibility for Implementation

The Heads of the Ministry's Office; the Director of the Traditional Medicine Management Department; the Heads of units under and affiliated with the Ministry of Health; the Directors of Provincial Health Departments; the Heads of health agencies of Ministries, sectors, and related organizations and individuals are responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals should promptly report to the Ministry of Health (Traditional Medicine Management Department) for consideration and resolution.

ANNEX I

LIST OF TOXIC MEDICINAL SUBSTANCES OF PLANT ORIGIN
(Annexed by Circular No. 13/2024/TT-BYT dated August 26, 2024 of the Minister of Health)

ANNEX II

LIST OF TOXIC MEDICINAL SUBSTANCES OF ANIMAL ORIGIN
(Annexed by Circular No. 13/2024/TT-BYT dated August 26, 2024 of the Minister of Health)

ANNEX III

LIST OF TOXIC MEDICINAL SUBSTANCES OF MINERAL ORIGIN
(Annexed by Circular No. 13/2024/TT-BYT dated August 26, 2024 of the Minister of Health)