How to update quality standards and apply updated pharmacopoeia in traditional medicine management in Vietnam?

How to update quality standards and apply updated pharmacopoeia in traditional medicine management in Vietnam?

Pursuant to Article 7 of Circular 38/2021/TT-BYT stipulating regulations on updating quality standards and applying updated pharmacopoeia as follows:

1. Within 2 years from the effective date of the current version of the pharmacopoeia, medicinal material businesses, traditional medicine production facilities, traditional medicine businesses, and medical facilities have the responsibility to update the quality standards of medicinal materials, traditional medicine ingredients, and traditional medicines according to the regulations of that pharmacopoeia version.

2. For traditional medicine ingredients and traditional medicines when applying for a marketing authorization: At the time of submitting the dossier, the quality standards of traditional medicine ingredients and traditional medicines must meet the requirements of the current version of the pharmacopoeia or previous versions of the pharmacopoeia but not more than 2 years from the date of that version's effectiveness.

3. During the course of business and use, if the medicinal material business, traditional medicine production facility, traditional medicine business, or medical facility discovers that there are factors that seriously affect the quality, safety, or efficacy of medicinal materials, traditional medicine ingredients, or traditional medicines, or as required by the Ministry of Health (Department of Traditional Medicine and Drug Administration), then they must update the quality standards of medicinal materials, traditional medicine ingredients, and traditional medicines according to the new pharmacopoeia version to control the influencing factors.

How to update quality standards and apply updated pharmacopoeia in traditional medicine management in Vietnam? - Source: Internet

What are regulations on the subjects and requirements for publishing the quality standards of medicinal materials in traditional medicine management in Vietnam?

Pursuant to Article 8 of Circular 38/2021/TT-BYT stipulating the subjects and requirements for publishing the quality standards of medicinal materials in traditional medicine management in Vietnam as follows:

1. Medicinal materials must be declared with quality standards before being marketed, including one of the following cases:

a) Medicinal materials that do not have quality standards specified in the Vietnamese Pharmacopoeia or pharmacopoeias of countries in the world specified in Clause 5 of this Circular;

b) Medicinal materials that have quality standards specified in the Vietnamese Pharmacopoeia or pharmacopoeias of countries in the world specified in Clause 5 of this Circular but the facility wants to declare quality indicators and quality levels higher than those specified in the pharmacopoeia.

2. The facilities that are allowed to declare quality standards include:

a) Medicinal material businesses in Vietnam;

b) Medicinal material businesses of foreign countries with representative offices in Vietnam.

What are the documents and procedures for publishing medicinal materials in traditional medicine management in Vietnam?

Pursuant to Article 9 of Circular 38/2021/TT-BYT stipulating the documents and procedures for publishing medicinal materials as follows:

1. The dossier for declaring the quality standards of medicinal materials must include the following documents:

a) A declaration of the quality standards of medicinal materials according to Form 02 Appendix I attached to this Circular;

b) A test report of medicinal materials that meets the quality standards that have been declared by a drug testing facility that meets the Good Laboratory Practice for Drugs (GLP) standards;

c) Documents proving the origin and provenance of medicinal materials according to the provisions of Article 13 of this Circular;

d) All documents in the declaration dossier must be in Vietnamese; if there are documents in foreign languages, they must be translated into Vietnamese or English and notarized according to regulations. All documents must be valid when declared. Businesses are responsible for the legal status and content of the declaration dossier.

2. The procedures for declaring the quality standards of medicinal materials are as follows:

a) Organizations and individuals submit one (01) set of dossiers via post, the Ministry of Health's (Department of Traditional Medicine and Drug Administration) website, or directly to the Ministry of Health (Department of Traditional Medicine and Drug Administration);

b) After receiving the declaration dossier from the organization or individual, within 05 days, the Ministry of Health (Department of Traditional Medicine and Drug Administration) is responsible for posting the following information on the website of the Department of Traditional Medicine and Drug Administration: Name of the organization or individual; name of the medicinal material declared; origin of the medicinal material; applicable quality standards; and sending it back to the inspection agency to conduct quality control according to regulations;

c) Immediately after being posted on the website of the Department of Traditional Medicine and Drug Administration, the organization or individual is entitled to trade in the medicinal material mentioned above and is fully responsible for the safety of that medicinal material;

d) In case of a change in the origin or provenance of the medicinal material, the organization or individual must re-declare.

Best regards!