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

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

Pursuant to Clause 1, 2, 3, 4, 5, 6 and 7, Article 22 of the Circular 21/2018/TT-BYT (amended by Clause 21 and 22, Article 1 of the Circular 39/2021/TT-BYT) stipulating procedures for adjustment of the certificate of traditional drug marketing authorization in Vietnam as follows:

1. The applicant for adjustment of the certificate of traditional drug marketing authorization (the applicant) shall submit an application for adjustment of the certificate of traditional drug marketing authorization (the adjustment application) prepared as prescribed in Article 19 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. 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.

7. The time limit for implementation of the amended contents of marketing authorizations of traditional drugs shall not exceed 6 months from the date on which the Director of the Traditional Medicine Administration promulgates an Official Dispatch on approval for amendments, except for cases under other requests of the Traditional Medicine Administration.

What are cases in which the drug registration establishments shall not submit the application o the Traditional Medicine Administration of Vietnam?

Pursuant to Clause 23 Article 1 of the Circular 39/2021/TT-BYT) stipulating cases in which the drug registration establishments shall not submit the application o the Traditional Medicine Administration of Vietnam as follows:

In some cases of amendments, the drug registration establishments and manufacturers shall update on labels and instructions for drug use and not submit the application or notification to the Traditional Medicine Administration. To be specific:

a) Carry out labeling and package inserts of drugs and medicinal ingredients according to regulations of Clause 2, Article 35 of the Circular No. 01/2018/TT-BYT dated January 18, 2018 of the Ministry of Health on labeling and package inserts of drugs and medicinal ingredients;

b) Amend the contents of labels and package inserts in accordance with the contents of the written request of the Director of the Traditional Medicine Administration;

c) Other contents

- Change of information on the importers of drugs or medicinal ingredients stated on the labels or package inserts of the drugs;

- Correct spelling mistakes on the labels or package inserts;

- Change the layout of the items in the package insert without change in the approved contents of the package insert;

- Add information on standards of the quality on labels and package inserts according to the application approved by the Director of the Traditional Medicine Administration;

- The amended contents shall comply with the document of the Director of the Traditional Medicine Administration on notification of the results of the appraisal of the application for drugs and medicinal ingredients.

What are priority cases in which the time limit for issuing the certificate of traditional drug marketing authorization in Vietnam is likely to be reduced?

Pursuant to Article 23 of the Circular 21/2018/TT-BYT (amended by Clause 24 Article 1 of the Circular 39/2021/TT-BYT) stipulating priority cases in which the time limit for issuing the certificate of traditional drug marketing authorization in Vietnam is likely to be reduced as follows:

1. The time limit for issuing the certificate of traditional drug marketing authorization specified in Article 20 of this Circular is likely to be reduced on the basis of the request made by the applicant in the application form (Form No. 03A or No. 03B in the Appendix I hereof) if:

a) The drug serves purposes related to national defense and security, prevention and elimination of epidemics, disaster recovery, or need for special treatment;

b) The drug is domestically manufactured on new lines satisfying GMP standards within 12 months from the date in which the GMP certificate is issued.

c) The drug is derived from domestic herbal materials satisfying GACP requirements.

2. Applications and procedures for traditional drugs in case of priority given to the reduction in time

a) Traditional drugs that are not subject to clinical trials: within 04 months from the date of receipt of the applications, the receiving agency shall carry out the procedures specified in Clauses 3, 5 and 6, Article 20 of this Circular;

b) Traditional drugs that are subject to clinical trials: within 08 months from the date of receipt of the applications, the receiving agency shall carry out the procedures specified in Clauses 4, 5 and 6 Article 20 of this Circular;

Best regards!