What documents are included in the application for extension of the certificate of herbal material marketing authorization in Vietnam?

What documents are included in the application for extension of the certificate of herbal material marketing authorization in Vietnam?

Pursuant to Article 27 of the Circular 21/2018/TT-BYT stipulating the application for extension of the certificate of herbal material marketing authorization in Vietnam as follows:

An application for extension of the certificate of herbal material marketing authorization includes:

1. An application form (Form No. 04C in the Appendix I hereof).

2. Documents specified in Clauses 2 and 3 Article 25 of this Circular and documents specified in Clauses 6 and 7 Article 25 of this Circular if the herbal material has its administrative documents changed on the extension date.

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

4. A report on safety and efficacy of the herbal material on the list of toxic herbal materials promulgated by the Minister of Health (Form No. 08 in the Appendix I hereof).

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

What documents are included in the application for adjustment of the certificate of herbal material marketing authorization in Vietnam?

Pursuant to Article 28 of the Circular 21/2018/TT-BYT stipulating the application for adjustment of the certificate of herbal material marketing authorization in Vietnam as follows:

An application for adjustment of the certificate of herbal material marketing authorization includes:

1. An application form (Form No. 05C in the Appendix I hereof).

2. Relevant documents about the adjustments specified in the Appendix II hereof.

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

What are procedures for issuance of the certificate of herbal material marketing authorization in Vietnam?

Pursuant to Article 29 of the Circular 21/2018/TT-BYT (amended by Clause 26 Article 1 of the Circular 39/2021/TT-BYT) stipulating procedures for issuance of the certificate of herbal material marketing authorization in Vietnam as follows:

1. The applicant for issuance of the certificate of herbal material marketing authorization (the applicant) shall submit an application for issuance of the certificate of herbal material marketing authorization (the marketing application) prepared as prescribed in Articles 24, 25 and 26 of this Circular to the Traditional Medicine Administration of Vietnam - the Ministry of Health (the receiving authority), whether directly, by post or through the online public service system of the Ministry of Health.

2. Upon receipt of the satisfactory application, the receiving authority shall give the applicant the Form No. 02 enclosed herewith. If the application is unsatisfactory, the receiving authority shall request the applicant in writing or request the applicant (if the application is submitted directly) to complete it as prescribed.

3. Within 06 months from the date of receipt of the application, the receiving agency shall grant written approval or disapproval of issuance of marketing authorizations of herbal ingredients. To be specific:

a) Within 15 days from the date of receipt of the application, the receiving agency shall transfer the application to the appraiser;

b) Within 60 days from the date on which the appraisers consider and give their opinions, the receiving agency will transfer the applications for issuance or refusal of issuance of marketing authorizations of drugs and medicinal ingredients or the application for appraisal and counseling to the Office of the Advisory Council for submission to the Advisory Council.

c) Within 15 days from the date on which the Advisory Council gives its opinions, the Minister of Health shall authorize the Director of the Traditional Medicine Administration of Vietnam to issue or refuse to issue marketing authorizations of herbal ingredients or request amendments according to the request of the Advisory Council.

4. If the application fails to meet the requirements specified in Articles 24, 25 and 26 of this Circular, within the time limit for consideration of the application, the receiving agency shall promptly provide specific instructions for the registration establishment in order to amend the applications until the application meets the requirements. The time and number of times that the registration establishment amends the application shall comply with Clause 9 Article 4 of this Circular.

5. If the application is rejected as prescribed in Clause 3 of this Article, the receiving authority shall respond and provide explanation in writing.

What are procedures for extension of the certificate of herbal material marketing authorization in Vietnam?

Pursuant to Article 30 of the Circular 21/2018/TT-BYT (amended by Article 1 of the Circular 39/2021/TT-BYT) stipulating procedures for extension of the certificate of herbal material marketing authorization in Vietnam as follows:

1. At least 03 months before the expiration date of the certificate of marketing authorization, the applicant shall submit an application for extension of the certificate of herbal material marketing authorization (the extension application) prepared as prescribed in Article 27 of this Circular to the Traditional Medicine Administration of Vietnam - the Ministry of Health (the receiving authority), whether directly, by post or through the online public service system. The applicant that fails to submit the extension application by the aforementioned deadline shall follow the procedures for issuance of the marketing authorization certificate as prescribed in Article 30 of this Circular.

2. Upon receipt of the satisfactory application, the receiving authority shall give the applicant the Form No. 02 enclosed herewith. If the application is unsatisfactory, the receiving authority shall request the applicant in writing or request the applicant to complete it as prescribed.

3. Within 03 months from the date of receipt of the application, the receiving agency shall grant written approval or disapproval of extension of marketing authorizations of herbal ingredients. To be specific:

a) Within 05 days from the date of receipt of the application, the receiving agency shall transfer the application to the appraiser;

b) Within 30 days from the date on which the appraisers consider and give their opinions, the receiving agency will transfer the applications for issuance or refusal of issuance of marketing authorizations of drugs and medicinal ingredients or the application for appraisal and counseling to the Office of the Advisory Council for submission to the Advisory Council.

c) Within 15 days from the date on which the Advisory Council gives its opinions, the Minister of Health shall authorize the Director of the Traditional Medicine Administration of Vietnam to extend or refuse to extend marketing authorizations of herbal ingredients or request amendments according to the request of the Advisory Council.

4. If the application fails to meet the requirements specified in Article 27 of this Circular, within the time limit for consideration of the application, the receiving agency shall promptly provide specific instructions for the registration establishment in order to amend the application until the application meets the requirements. The time and number of times that the registration establishment amends the application shall comply with Clause 9 Article 4 of this Circular.

5. If the application is rejected, the receiving authority shall respond and provide explanation in writing.

Best regards!