Circular stipulates on the delegation of authority in the field of traditional medicine and pharmacy

CIRCULAR

Regulations on分级管理在中医药领域的规定

Pursuant to the Law on Government Organization No. 63/2025/QH15;

Pursuant to the Medicine Law number 105/2016/QH13 amended and supplemented by the Medicine Law number 44/2024/QH15;

Pursuant to Decree number 42/2025/NĐ-CP 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 regulations regarding graded management in the field of traditional medicine.

Article 1. Graded authority of the Minister of Health shall be implemented for evaluation, maintenance evaluation, change evaluation, supplementation of medicinal materials meeting Good Agricultural and Collection Practices (hereinafter referred to as GACP), reissuing, revoking Certificates of Medicinal Materials Meeting GACP

1. Graded authority for the People's Committee of the province to implement evaluation, maintenance evaluation, change evaluation, supplementation of medicinal materials meeting GACP, reissuing, revoking Certificates of Medicinal Materials Meeting GACP as stipulated in Article 8 and Article 17 of Circular No. 19/2019/TT-BYT on Good Agricultural and Collection Practices for medicinal materials and principles, standards for harvesting natural medicinal materials.

2. Documents, procedures, and processes for evaluation, maintenance evaluation, change evaluation, supplementation of medicinal materials meeting GACP, reissuing, revoking Certificates of Medicinal Materials Meeting GACP shall be carried out in accordance with the provisions in Appendix I and Appendix II attached hereto.

3. Composition and criteria for members of the Evaluation Team issuing Certificates of Medicinal Materials Meeting GACP shall be carried out in accordance with the provisions in Appendix III attached hereto.

Article 2. Responsibilities for Implementation

1. The Traditional Medicine Management Department shall be responsible for:

a) To organize, guide, and inspect the implementation of this Circular throughout the country;

b) To organize training, capacity building, and enhancement of work capabilities for evaluation of GACP for agencies receiving applications in areas where medicinal materials are cultivated, harvested, and collected;

c) To announce on the electronic information website of the Traditional Medicine Management Department the Certificates of Medicinal Materials Meeting GACP issued by the Traditional Medicine Management Department before the effective date of this Circular and the Certificates of Medicinal Materials Meeting GACP stipulated in Article 3 of this Circular so that relevant entities can monitor and determine the validity period and time for requesting maintenance evaluation to meet GACP requirements;

d) To provide information, documents, and evaluation files for agencies receiving applications for applications for GACP evaluation where the Traditional Medicine Management Department has already issued Certificates of Medicinal Materials Meeting GACP.

2. The People's Committee of the province shall be responsible for organizing, guiding, and inspecting the implementation of this Circular within its jurisdiction.

Article 3. Transitional Provisions

In cases where applications have been submitted before the effective date of this Circular, the agency receiving the application shall continue to process them according to current regulations until the administrative procedure is completed.

Article 4. Effective date

This Circular shall take effect from July 1, 2026.

During the implementation process, if there are difficulties or obstacles, please report to the Ministry of Health (Traditional Medicine Management Department) for resolution./.