What are regulations on application for issuance of certificate of herbal material marketing authorization in Vietnam?

What are regulations on application for issuance of certificate of herbal material marketing authorization in Vietnam?

Pursuant to Article 24 of the Circular 21/2018/TT-BYT stipulating the application for issuance of certificate of herbal material marketing authorization in Vietnam as follows:

The application for issuance of the certificate of herbal material marketing authorization shall prepared as prescribed in Clause 2 Article 56 of the Law on Pharmacy. It consists of:

1. Administrative documents specified in Article 25 of this Circular.

2. Technical documents specified in Article 26 of this Circular.

3. A sample label of the herbal material sold at the home country or reference country (for imported herbal materials).

What are regulations on administrative documents for issuance, extension and adjustment of certificate of herbal material marketing authorization in Vietnam?

Pursuant to Article 25 of the Circular 21/2018/TT-BYT stipulating the administrative documents for issuance, extension and adjustment of certificate of herbal material marketing authorization in Vietnam as follows:

Administrative documents include:

1. An application form (Form No. 03C in the Appendix I hereof).

2. Legal documents if the applicant is a manufacturer:

a) A copy of the certificate for eligibility for pharmacy business containing the scope of domestic herbal material/prepared traditional medicinal material trading and manufacturing;

b) A copy of the enterprise marketing authorization certificate of the domestic herb farming establishment;

c) The license for establishment of representative office in Vietnam and License for herbal material/prepared herbal material manufacturing and trading issued by a competent foreign authority to the herbal material/prepared herbal material manufacturer that has a representative office in Vietnam.

3. Legal documents if the applicant is not a manufacturer:

a) Herbal material manufacturer’s legal documents specified in Clause 2 of this Article;

b) Legal documents of the applicant;

- A copy of the certificate for eligibility for pharmacy business, for the domestic manufacturer that has one of the following scopes of business: manufacturing, wholesale, import or export of herbal materials or prepared traditional medicinal materials;

- The license for establishment of representative office in Vietnam and License for herbal material/prepared herbal material manufacturing and trading issued by a competent foreign authority to the applicant that has a representative office in Vietnam.

4. A power of attorney made as prescribed in Clause 5 Article 4 of this Circular if the applicant is authorized.

5. A summary of the herbal material (Form No. 06C in the Appendix I hereof).

6. A sample label of the herbal material. Contents of the label shall comply with regulations on labeling of drugs and pharmaceutical starting materials and package inserts.

7. A package insert made in accordance with regulations of the Ministry of Health on labeling of drugs and pharmaceutical starting materials and package inserts.

8. Other documents (if any).

What are regulations on technical documents for issuance, extension and adjustment of certificate of herbal material marketing authorization in Vietnam?

Pursuant to Article 26 of the Circular 21/2018/TT-BYT (amended by Clause 25 Article 1 of the Circular 39/2021/TT-BYT) stipulating technical documents for issuance, extension and adjustment of certificate of herbal material marketing authorization in Vietnam as follows:

Technical documents include:

1. Documents about the preparing process shall satisfy the following requirements:

a) A formula for the smallest pack: name of the material; applied standard;

b) A formula for a batch: name of the material; mass or volume of each material;

c) A diagram of preparing process, including all stages in the preparing process;

d) A description of preparing process: sufficiently and specifically describe every stage in the preparing process;

dd) A list of equipment or tools used in preparing process: name of the equipment, their specifications and purposes; marketing authorization or declaration number (if any);

e) Documents about control of the preparing process: sufficiently and specifically describe testing and control criteria in manufacturing process.

2. Documents about quality standards and testing methods shall satisfy the following requirements:

a) Standards applied to herbal materials: sufficiently and specifically describe criteria and methods for herbal material testing;

b) Packaging standards: sufficiently and specifically describe testing criteria and methods;

c) A herbal material testing report shall satisfy the following requirements:

- The herbal material manufacturer that has a herbal material testing laboratory satisfying GLP requirements prescribed by the Ministry of Health shall appraise testing standards and methods itself, and include its testing report in the marketing application;

- The herbal material manufacturer that has not yet had a drug testing laboratory satisfying GLP requirements prescribed by the Ministry of Health shall appraise testing standards and methods itself, and include the testing reports of state-owned drug-testing facilities or drug-testing service providers that have been issued with the certificate of eligibility for pharmacy business in the marketing application.

d) Quantity of testing reports:

- 01 testing report on herbal ingredients; If the herbal ingredients have been supplied by many different manufacturers, it is required to have only 01 representative testing report of herbal ingredients);

- 01 testing report on packaging;

Best regards!