Chương III Thông tư 38/2021/TT-BYT: Công bố tiêu chuẩn chất lượng dược liệu

Chapter III

PUBLICATION OF QUALITY STANDARDS FOR HERBAL MATERIALS

Article 8. Regulated entities and requirements for publication of quality standards for herbal materials

1. Herbal materials of which quality standards must be published before they are sold include:

a) Herbal materials for which quality standards are not prescribed in Vietnam’s pharmacopoeia or other foreign pharmacopoeias prescribed in Article 5 hereof;

b) Herbal materials for which quality standards are prescribed in Vietnam’s pharmacopoeia or a foreign pharmacopoeia prescribed in Article 5 hereof but establishments wish to publish quality indices and levels that are higher than those prescribed in the pharmacopoeia.

2. Establishments permitted to publish quality standards include:

a) Trading establishments of herbal materials in Vietnam;

b) Trading establishments of herbal materials in foreign countries which have representative offices located in Vietnam.

Article 9. Dossiers and procedures for publication of herbal materials:

1. A dossier of publishing herbal material quality includes:

a) A written document of publishing herbal material quality under Form 02 Appendix I issued herewith;

b) A testing form for herbal materials meeting quality standards published by institutions testing drugs and medicinal ingredients up to Good Laboratory Practice (GLP) standards;

c) Written proofs of origin of herbal materials as prescribed in Article 13 hereof;

d) Documents contained in the dossier must be written in Vietnamese; must be translated into Vietnamese or English and notarized as prescribed in case of foreign documents. All documents must be still valid in the date of publication. Trading establishments must be responsible for the legality and contents of the dossier.

2. Procedures for publishing quality of herbal materials

a) An organization or individual shall submit one (01) dossier by post, via the website of TMA of the Ministry of Health or in person at TMA of the Ministry of Health;

b) After receiving the dossier of publishing of the organization or individual, within 05 days, the Ministry of Health (via TMA) shall be responsible for consideration of updating the following contents on the website of TMA: name of the organization or individual; name of herbal materials, origin of them; quality standards applied and sent to testing authorities for quality control as prescribed;

c) Immediately after being updated on the website by TMA, the organization or individual shall have the right to sell the above-mentioned herbal materials and take full responsibility for the safety of such herbal materials;

d) In case of a herbal material of which its origin changes, the individual must re-make the procedures for publication of it.

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