What are regulations on application for issuance of a certificate of traditional drug marketing authorization in Vietnam?

What are regulations on application for issuance of a certificate of traditional drug marketing authorization in Vietnam?

Pursuant to Article 15 of the Circular 21/2018/TT-BYT stipulating application for issuance of a certificate of traditional drug marketing authorization in Vietnam as follows:

The application for issuance of a certificate of traditional drug marketing authorization shall be prepared as prescribed in Clause 2 Article 56 of the Law on Pharmacy and include:

1. Administrative documents specified in Article 16 of this Circular.

2. Technical documents specified in Article 17 of this Circular.

3. A sample label of the traditional drug sold at the home country or reference country (for imported traditional drugs).

What are regulations on administrative documents for issuance of a certificate of traditional drug marketing authorization in Vietnam?

Pursuant to Article 16 of the Circular 21/2018/TT-BYT (amended by Clause 15, 16, and 17, Article 1 of the Circular 39/2021/TT-BYT) stipulating administrative documents for issuance of a certificate of traditional drug marketing authorization in Vietnam as follows:

Administrative documents include:

1. An application form (Form No. 03A or No. 03B in the Appendix I hereof).

2. Legal documents if the applicant is a manufacturer:

a) Copy of certificate of eligibility to trade herbal ingredients and traditional drugs with the scope for trade and production of traditional drugs or herbal ingredients for domestic drug manufacturers;

b) A CPP granted to the imported traditional drug, for the foreign manufacturer, except for prepared traditional medicinal material. If the CPP does not specify the manufacturer satisfy GMP standards, a GMP of the foreign manufacturer is required. If multiple manufacturers engage in the drug manufacturing process, the certificate of GMP of these manufacturers is required.

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

a) Legal documents mentioned in Points a and b Clause 2 of this Article;

b) The legal documents of the establishment that makes marketing authorization of traditional drugs shall includes one of the following documents:

- Copy of certificate of eligibility to trade herbal ingredients and traditional drugs for the domestic establishment with one of the scope for trade: production, business, export or import of traditional drugs or herbal ingredients;

- License to establish representative office in Vietnam; certificate of eligibility to produce and trade herbal ingredients and traditional drugs issued by the foreign competent state management agency according to regulations for the foreign establishment with one of the scope for trade: production, business, export or import of drugs.

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 traditional drug (Form No. 06A or No. 06B in the Appendix I hereof);

6. A sample label of the traditional drug. 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. Documents about data security specified in Article 6 of this Circular (if any).

9. Other documents (if any).

10. Copy of legal document of the establishment which produces excipients, capsule shells, semi-finished herbal ingredients and herbal ingredients for the production of traditional drugs according to Clause 8 Article 4 of this Circular.

What are regulations on technical documents for issuance of a certificate of traditional drug marketing authorization in Vietnam?

Pursuant to Article 17 of the Circular 21/2018/TT-BYT (amended by Clause 18 Article 1 of the Circular 39/2021/TT-BYT) stipulating technical documents for issuance of a certificate of traditional drug marketing authorization in Vietnam as follows:

Administrative documents include:

1. Document on the process of production according to Form No. 02/TT issued together with this Circular shall satisfy the following requirements:

a) Documents on raw ingredients: Describe the process of preliminary processing and processing of ingredients of herbal ingredient in a detailed and complete manner. In case of raw ingredients that are semi-finished herbal ingredients (ingredients in the form of glue, granule, powder), it is required to have the detailed description of the process of production of semi-finished herbal ingredients from ingredients of herbal ingredients (except for semi-finished herbal ingredients which have been granted marketing authorizations);

b) Document on finished drugs shall fully show the following information:

- Formula for smallest package unit: names of ingredients (including herbal ingredients, auxiliary ingredients and excipients); standards of application of ingredients. In case of production from ingredients in the form of glue that have not been standardized in terms of content of active ingredients, the corresponding content of herbal ingredients shall be clearly stated;

- Formula for a batch of production: names of ingredients including main ingredients and excipients; mass or volume of each ingredient;

- Diagram of the process of production: all stages in the production process;

- Description of the process of production: Detailed description of each stage in the production process;

- List of equipment and tools used in the process of production: name of equipment, parameters, capacity, model, purpose of use, status of use, registration number or declaration (if any);

- Control in the process of production: Detailed description of the criteria for inspection and control in the production process.

2. Documents on standards of the quality and methods of testing of drugs shall meet the following requirements:

a) Standards of ingredients:

- Herbal ingredients that fall into the pharmacopoeia: Specify the name of the pharmacopoeia and the year of publication;

- Herbal ingredients that fall outside in the pharmacopoeia: Describe criteria and testing methods in a detailed and complete manner;

- Standards of auxiliary materials in the processing of herbal ingredients: The establishment shall have measures to control the quality of the auxiliary materials. Auxiliary materials with national standards: Write the standard number.

b) Standards of finished drugs: Describe criteria and testing methods in a detailed and complete manner

b) Standards of packaging: Describe criteria and testing methods in a detailed and complete manner

d) Testing reports:

- The traditional drug production establishments which have laboratories under Good Drug Laboratory Practice (GLP) according to the regulations of the Ministry of Health shall self-evaluate the testing standards and methods and submit their own testing reports;

- The traditional drug manufacturing establishments that do not have laboratories under Good Laboratory Practices (GLP) according to the regulations of the Ministry of Health shall appraise the testing standards and methods and submit testing reports of the drug testing facilities that meet GLP or the drug testing service providers that has been issued certificates of eligibility to trade herbal ingredients and traditional drugs

- Quantity of testing reports:

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

01 testing report on semi-finished herbal ingredients of the manufacturer of semi-finished herbal ingredients. If the semi-finished herbal ingredients have been supplied by many different manufacturers, it is required to have only 01 testing report that is representative and 01 testing report on semi-finished herbal ingredients of the manufacturer of finished drugs);

01 testing report on finished drugs;

01 testing report on packaging;

Chromatographic images of the qualitative and quantitative tests throughout the testing.

dd) Requirements for stability studies:

Traditional medicine production establishments shall study and have documents that prove the stability, including:

- Stability study outline;

- Stability study data;

- Stability study conclusion;

- The testing reports on finished drugs of the stability monitoring samples shall include 03 samples at the initial time; 03 samples at the time after the shelf life in the long-term condition and 03 samples at the end of the stability study under the condition of the accelerated aging.

3. Documents proving a drug satisfies requirements for safety and efficacy include:

a) Regarding the traditional drug:

- Clinical and pre-clinical study reports commissioned and approved by the competent authority, enclosed with a certified true copy of the written approval for study result given by the competent authority in the cases mentioned in Articles 7, 8, 9 and 10 of this Circular;

- Reports on toxicity of the traditional drug that contains toxic herbal materials on the list of toxic herbal materials derived from minerals in the Appendix III and toxic herbal materials not starred (*) on the list of toxic herbal materials derived from plants and animals in the Appendix I and Appendix II enclosed with the Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Ministry of Health on the List of toxic herbal materials.

b) Regarding the prepared traditional medicinal material: Reports on toxicity of the traditional drug that contains toxic herbal materials on the list of toxic herbal materials derived from minerals in the Appendix III and toxic herbal materials not starred (*) on the list of toxic herbal materials derived from plants and animals in the Appendix I and Appendix II enclosed with the Circular No. 42/2017/TT-BYT dated November 13, 2017 of the Ministry of Health on the List of toxic herbal materials promulgated together with the result of analysis of toxicity of the traditional drug carried out a competent authority.

4. Documents proving that the traditional drug fails to satisfy criteria for exemption from clinical trial or certain phases of clinical trial are prescribed in Article 11 of this Circular.

What are regulations on application for extension of the certificate of traditional drug marketing authorization in Vietnam?

Pursuant to Article 18 of the Circular 21/2018/TT-BYT stipulating application for extension of the certificate of traditional drug marketing authorization in Vietnam as follows:

An application for extension of the certificate of traditional drug marketing authorization includes:

1. An application form (Form No. 04A or No. 04B in the Appendix I hereof).

2. Documents specified in Clauses 2 and 3 Article 16 of this Circular and documents specified in Clauses 6 and 7 Article 16 of this Circular if the traditional drug has its administrative documents changed on the extension date.

3. A report on sale of the traditional drug (Form No. 10 in the Appendix I hereof).

4. A report on safety and efficacy of the drug if its safety and efficacy still has to be monitored (Form No. 08 in the Appendix I hereof).

5. A copy of the issued certificate of drug marketing authorization in Vietnam.

What are regulations on application for adjustment of the certificate of traditional drug marketing authorization in Vietnam?

Pursuant to Article 19 of the Circular 21/2018/TT-BYT stipulating application for adjustment of the certificate of traditional drug marketing authorization in Vietnam as follows:

An application for adjustment of the certificate of traditional drug marketing authorization includes:

1. An application form (Form No. 05A or No. 05B in the Appendix I hereof).

2. Technical documents about the adjustments: relevant documents specified in the Appendix II hereof.

3. A copy of the effective certificate of drug marketing authorization in Vietnam.

Best regards!