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

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.

What are procedures for issuance of the certificate of traditional drug marketing authorization in Vietnam?

Pursuant to Article 20 of the Circular 21/2018/TT-BYT (amended by Article 1 of the Circular 39/2021/TT-BYT) stipulating procedures for issuance of the certificate of traditional drug marketing authorization in Vietnam as follows:

1. The applicant for issuance of the certificate of traditional drug marketing authorization (the applicant) shall submit an application for issuance of the certificate of traditional drug marketing authorization (the marketing application) prepared as prescribed in Articles 15, 16 and 17 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 01 month from the date of receipt of the application, the receiving agency shall grant written approval or disapproval of extension of marketing authorizations of traditional drugs. 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 15 days from the date on which the appraiser completes appraisal, the receiving agency shall transfer the applications for issuance or refusal for 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 05 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 traditional drugs or request amendments according to the request of the Advisory Council.”

4. If the application fails to meet the requirements specified in Article 18 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 unsatisfactory as prescribed in Articles 15, 16 and 17 of this Circular, 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 of this Article, the receiving authority shall respond and provide explanation in writing.

What are procedures for extension of the certificate of traditional drug marketing authorization in Vietnam?

Pursuant to Article 21 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 traditional drug 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 traditional drug marketing authorization (the extension application) prepared as prescribed in Article 18 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. 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 20 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 (if the application is submitted directly) to complete it as prescribed.

3. In case of the marketing application of traditional drugs with minor variations as prescribed in Section II.2 Appendix II issued together with this Circular, the establishment can conduct the changed contents right after the date on which the receiving agency issues the receipt certificate to the applicant.

4. In case of marketing application of traditional drugs with major variations as prescribed in Section I, Appendix II and the marketing application of traditional drugs with minor variations in Section II.1 of Appendix II enclosed together with this Circular, within 01 month from the date of receipt of the application, the receiving agency shall grant written approval or disapproval of the changed contents of marketing authorizations of traditional drugs. 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 15 days from the date on which the appraiser completes appraisal, the receiving agency shall transfer the contents of changes in indications, dosages and drug users to the Office of the Advisory Council for issuance of marketing authorizations of drugs and medicinal ingredients for submission to the Advisory Council for approval or disapproval.

c) Within 05 days from the date on which the Advisory Council or the appraiser gives its opinions, the Minister of Health shall authorize the Director of the Traditional Medicine Administration of Vietnam to grant written approval or disapproval of the changed contents of marketing authorizations of traditional drugs.

5. If the application fails to meet the requirements specified in Article 19 of this Circular, within the time limit for consideration of the application for change, 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.”

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

Best regards!