THE MINISTRY OF HEALTH
THE DRUG ADMINISTRATION OF VIETNAM
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
Hanoi, May 25, 2023
On the Lists of 231 domestically-manufactured drugs eligible for extension of certificates of registration for circulation in Vietnam - Stage 184
THE DIRECTOR THE DRUG ADMINISTRATION OF VIETNAM
Pursuant to the Law No. 105/2016/QH13 Law on Pharmacy dated April 6, 2016;
Pursuant to the Government’s Decree No. 95/2022/ND-CP dated November 15, 2022, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to the Minister of Health’s Decision No. 1969/QD-BYT dated April 26, 2023, defining the functions, tasks, powers and organizational structure of the Drug Administration of Vietnam under the Ministry of Health;
Pursuant to the Minister of Health's Circular No. 08/2022/TT-BYT dated 9/5/2022, on marketing authorization of drugs and drug materials;
Pursuant to the conclusion of the Advisory Council for grant of circulation registration certificates for drugs and drug materials - the Ministry of Health;
At the proposal of the Head of the Drug Registration Department, under the Drug Administration of Vietnam.
Article 1. To promulgate the Lists of 231 domestically-manufactured drugs that are granted certificates of registration for circulation in Vietnam - Stage 184. To be specific:
1. List of 172 domestically-manufactured drugs with extended circulation registration certificates valid for 5 years (Appendix I hereto).
2. List of 52 domestically-manufactured drugs with extended circulation registration certificates valid for 3 years (Appendix II hereto).
3. List of 7 domestically-manufactured drugs with extended circulation registration certificates valid until December 31, 2025 (Appendix III hereto).
Article 2. Drug manufacturers and drug registration establishments shall:
1. Manufacture drugs according to the dossiers and documents registered with the Ministry of Health and print the registration number issued by the Ministry of Health of Vietnam on the drug label.
2. Only produce and release drugs subject to special control for circulation when they have a certificate of eligibility for pharmacy business within the scope of trading drugs subject to special control in accordance with the scope of operation of the establishments satisfying the provisions of Clause 5 Article 143 of the Government's Decree No. 54/2017/ND-CP dated May 8, 2017, detailing a number of articles of and providing measures for implementing the Pharmacy Law.
3. Update drug quality standards as prescribed in the Minister of Health's Circular No. 11/2018/TT-BYT dated May 4, 2018, on the quality of drugs and drug materials.
4. Implement, and coordinate with exporters in complying with Official Dispatch No. 5853/QLD-CL dated April 19, 2019, of the Drug Administration of Vietnam, on quality inspection of drug materials of sartan group regarding drugs containing active ingredients of the sartan group in the Lists specified in Article 1 that are promulgated together with this Decision.
5. Drugs that have the circulation registration certificate been extended under this Decision but have not yet submitted an application to update the contents of drug labels and instructions in accordance with the Minister of Health's Circular 01/2018/TT-BYT dated January 18, 2018, must be updated under Point b Clause 1 Article 37 of Circular No. 01/2018/TT-BYT within 12 months from the date of extension of the circulation registration certificate.
6. After 12 months from the date of signing and promulgating this Decision, the drugs eligible for extension of circulation registration certificates under this Decision that have changes in their administrative contents (including sample labels and instructions for drug use) must be manufactured and circulated with the approved change contents in the extension dossiers.
7. Coordinate with treatment establishments to follow applicable regulations on prescription drugs, monitor safety, effectiveness, and unwanted effects of drugs on Vietnamese people, and synthesize and report in accordance with Article 5 of Circular No. 08/2022/TT-BYT for drugs in Section I Appendix II to this Decision.
8. Drug registration establishments must maintain operating conditions during the validity periods of certificates of registration for circulation of drugs and drug materials. In case of failing to satisfy such conditions, the establishment must change the registration establishment in accordance with Circular No. 08/2022/TT-BYT within 30 days from the date on which the establishment no longer satisfies the operating conditions.
9. Drug manufacturers must maintain operating conditions applicable to drug manufacturers during the validity periods of certificates of registration for circulation of drugs and drug materials.
10. Drugs of which the circulation registration certificates have been extended under this Decision may continue to use their registration numbers issued before extension for a maximum period of 12 months, from the date on which the extended registration numbers are granted in accordance with Appendix VI to Circular No. 08/2022/TT-BYT.
11. For drugs of which the circulation registration certificates are extended in Section II, Appendix II of this Decision, after the expiry of the circulation registration certificates, if there is no clinical data to prove the drugs’ safety and efficiency in their extension dossiers, the Drug Administration of Vietnam shall submit to the Advisory Council for grant of circulation registration certificates for drugs and drug materials to refuse to continue extending the circulation registration certificates.
Article 3. This Decision takes effect from the date of its signing.
Article 4. Directors of Departments of Health of provinces and centrally-run cities, and Directors of drug manufacturers and drug registration establishments with drugs mentioned in Article 1 shall implement this Decision./.
VU TUAN CUONG
* All Appendices are not translated herein.