What are procedures for adjustment of the certificate of herbal material marketing authorization in Vietnam?
What are procedures for adjustment of the certificate of herbal material marketing authorization in Vietnam? In which cases shall the drug registration establishments not submit the application to the Traditional Medicine Administration of Vietnam? What are priority cases in which the time limit for issuing the certificate of herbal material marketing authorization in Vietnam is likely to be reduced?
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What are procedures for adjustment of the certificate of herbal material marketing authorization in Vietnam?
Pursuant to Clause 1, 2, 3, 4, 5, 6 and 7, Article 31 of the Circular 21/2018/TT-BYT (amended by Clause 28 and 29, Article 1 of the Circular 39/2021/TT-BYT) stipulating procedures for adjustment of the certificate of herbal material 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 herbal material marketing authorization (the adjustment application) prepared as prescribed in Article 28 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 to complete it as prescribed.
3. In case of the marketing application of herbal ingredients 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 grants the receipt certificate to the applicant.
4. In case of marketing application of herbal ingredients with major variations as prescribed in Section I, Appendix II and the marketing application of herbal ingredients 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 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 15 days from the date on which 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 herbal ingredients for the applications that meet requirements.”
5. If the application fails to meet the requirements specified in Article 28 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 herbal ingredients 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.
In which cases shall the drug registration establishments not submit the application to the Traditional Medicine Administration of Vietnam?
Pursuant to Clause 8 Article 31 of the Circular 21/2018/TT-BYT (amended by Clause 30 Article 1 of the Circular 39/2021/TT-BYT) stipulating cases in which the drug registration establishments not submit the application to the Traditional Medicine Administration of Vietnam as follows:
8. In some cases of amendments, the drug registration establishments and manufacturers shall update on labels and not submit the application or notification to the Traditional Medicine Administration. To be specific:
a) Carry out labeling of herbal 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 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 herbal ingredients stated on the labels;
- Correct spelling errors on the labels;
- Add information on standards of the quality on labels according to the application approved by the Director of the Traditional Medicine Administration;
- The amended contents shall comply with the document 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 herbal material marketing authorization in Vietnam is likely to be reduced?
Pursuant to Article 32 of the Circular 21/2018/TT-BYT (amended by Clause 31 and 32, Article 1 of the Circular 39/2021/TT-BYT) stipulating priority cases in which the time limit for issuing the certificate of herbal material marketing authorization in Vietnam is likely to be reduced as follows:
1. The time limit for issuing the certificate of herbal material marketing authorization specified in Article 29 of this Circular is likely to be reduced on the basis of the request made by the applicant in the application form (Form No. 03C in the Appendix I hereof) if:
a) The herbal material is domestically collected in accordance with GACP requirements.
b) The herbal material has just been acclimatized to Vietnam so that it can be cultivated on the basis of scientific researches aimed at proving its effect and quality within 12 months from the date on which the scientific research result is obtained.
c) Herbal ingredients used to produce drugs shall meet urgent needs for national defense and security, disease prevention and control, natural disaster recovery and special treatment.
2. Documents and procedures intended for the priority cases shall comply with Article 29 of this Circular.
a) 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 for herbal ingredients that are prioritized for consideration of reduction in the time for issuance of marketing authorization according to regulations of Points a, b Clause 1 of this Article.
b) Within 01 month from the date of receipt of the applications, the receiving agency shall carry out the procedures specified in Clauses 3, 4 and 5, Article 29 of this Circular for herbal ingredients that are prioritized for consideration of reduction in the time for issuance of marketing authorization according to regulations of Point c Clause 1 of this Article.
Best regards!