Procedures for issuance of the certificate of traditional drug marketing authorization in Vietnam

According to Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam, procedures for issuance of the certificate of traditional drug marketing authorization are prescribed as follows:

1. The applicant for issuance of the certificate of traditional drug marketing authorization shall submit an application for issuance of the certificate of traditional drug marketing authorization to the Traditional Medicine Administration of Vietnam - the Ministry of Health, 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. Regarding the traditional drug that is fully exempt from clinical trial, within 06 months from the receipt of the satisfactory application, the receiving authority shall:

- assess the application;

- submit the satisfactory application to the Advisory Council;

- issue the certificate of traditional drug marketing authorization at the request of the Advisory Council.

4. Regarding the traditional drug that is required to undergo clinical trial, within 12 months from the receipt of the satisfactory application, the receiving authority shall follow the procedures specified in Points a, b and c Clause 3 Article 20 of this Circular.

5. If the application is unsatisfactory, during the period of consideration of the application, the receiving authority shall promptly instruct the applicant in writing to complete the application until it is satisfactory. The application shall be completed within 60 days from the date on which the applicant is instructed in writing. The length of time of the completion of the application shall not add to the time limit for considering the application. After the aforementioned deadline, the application will be rejected and the applicant has to reapply for marketing authorization.

6. If the application is rejected as prescribed in Clauses 3 and 4 Article 20 of this Circular, the receiving authority shall respond and provide explanation in writing.

View details about the procedures for extension of the certificate of traditional drug marketing authorization at Circular No. 21/2018/TT-BYT of the Ministry of Health of Vietnam, effective from October 28, 2018.

- Thanh Lam -

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