Chương V Thông tư 11/2021/TT-BYT: Điều khoản thi hành

Chapter V

IMPLEMENTATION CLAUSE

Article 26. Effect

This Circular comes into force from the date on which it is signed to December 31, 2022.

Article 27. Transitional clauses

1. Applications for vaccine marketing authorization submitted to receiving authorities before the entry into force of this Circular and currently being processed shall adhere to relevant regulations in this Circular that are favorable to the applicants.

2. If this Circular expires and is not replaced by another document or does not have its effective period extended:

a) Applications for issuance and renewal of vaccine marketing authorizations and application for amendment to unexpired vaccine marketing authorizations must be submitted according to regulations in Circular No. 32/2018/TT-BYT;

b) Applications for vaccine registration submitted according to regulations of this Circular but not yet granted a marketing authorization must be revised according to regulations in Circular No. 32/2018/TT;

c) For imported vaccine batches delivered from exporting ports of export countries before January 01, 2023, vaccine labels and package inserts shall adhere to regulations in Clause 2 Article 7 herein.

For imported vaccine batches delivered from exporting ports of export countries after December 31, 2022, vaccine labels and package inserts shall adhere to regulations in Circular No. 01/2018/TT-BYT.

Article 28. Terms of reference

In case the legislative documents and regulations referred to herein are amended or superseded, the newest documents shall apply.

Article 29. Implementing responsibility

1. Drug Administration of Vietnam shall:

a) Provide guidelines for and organize implementation of regulations in this Circular;

b) Update content of vaccine labels and package inserts within 05 working days after the date of issuance or renewal of or amendment to marketing authorization and other vaccine registration information on the website of Drug Administration of Vietnam.

c) Within 02 days after the date of issuance or renewal of or amendment to marketing authorization, Drug Administration of Vietnam shall return the vaccine labels and package insert to the applicant and post the approved labels and package insert on its website;

d) Formulate, promulgate and implement standard operating procedures (SOPs) for vaccine registration according to regulations in this Circular.

dd) If an applicant or manufacturing facility is found to have forged or edited a legal document or document of a Vietnamese or foreign regulatory body without permission, or used a fake seal or forged a signature or seal of the applicant, manufacturing facility or another relevant facility in the vaccine registration application, Drug Administration of Vietnam shall handle it according to regulations in Point d and Point dd Clause 1 Article 58 of the Law on Pharmacy and Clauses 2, 3 and 4 Article 100 of Decree No. 54/2007/ND-CP.

Besides the abovementioned methods, Drug Administration of Vietnam shall publish violations committed by the facilities on its website and notify competent inspectorate and authority for consideration and handling as per the law;

e) Where necessary, Drug Administration of Vietnam shall hold meetings with applicants, manufacturing facilities and assessors to clarify difficulties related to assessment of vaccine registration applications.

2. Administration of Science Technology and Training shall:

a) Take charge of providing guidance on and organizing assessment and commissioning of  results of assessment of clinical trials of domestic vaccines before and after marketing authorization is granted; and results of safety and immunogenicity testing on the target population in Vietnam of foreign vaccines as per regulations;

b) Notify Drug Administration of Vietnam of results of clinical trial commissioning of the national research ethics committee for vaccines undergoing clinical trials before and after marketing authorization is granted.

3. General Department of Preventive Medicine shall:

a) Add training and supervision of using facilities to vaccination procedures to ensure that health officials use vaccines in compliance with procedures and content of package inserts approved by Drug Administration of Vietnam;

b) Receive, assess and consolidate information related to adverse events following immunization;

c) Share information on vaccine injury cases with Drug Administration of Vietnam as per regulations;

d) Take charge of providing guidance on and controlling eligibility, quantity and scope of use of vaccines in circulation for the vaccines mentioned in Clause 3 Article 11 herein.

 4. National Institute for Control of Vaccine and Biologicals shall:

a) Assess documents and send assessment results and professional recommendations related to documents on quality (if any) to Drug Administration of Vietnam for consolidation;

b) Keep document-related information confidential as per existing regulations;

c) Cooperate with manufacturing facilities and import facilities in COVID-19 vaccine quality control before use as per existing regulations.

5. Clinical pharmacology center of Hanoi Medical University shall:

a) Assess documents and send assessment results and professional recommendations related to pharmacological and clinical documents (if any) to Drug Administration of Vietnam for consolidation;

b) Keep document-related information confidential as per existing regulations;

6. National DI &ADR Center shall:

a) Receive, consolidate and report information related to adverse events following immunization to General Department of Preventive Medicine;

b) Receive and consolidate reports on vaccine safety and effectiveness assessment from pharmacy businesses, and submit the reports to Drug Administration of Vietnam, General Department of Preventive Medicine and relevant units.

7. Departments of Health shall inspect the implementation of this Circular by pharmaceutical manufacturers and businesses under their management.

8. Affiliates of the Ministry of Health, Vinapharm and vaccine businesses shall implement this Circular.

9. Vaccination facilities must formulate vaccination procedures, and train and supervise health officials to ensure that they use vaccines as per procedures and have full access to content of package inserts approved by Drug Administration of Vietnam.

10. Import facilities shall cooperate with applicants in providing approved labels and package inserts in Vietnamese for vaccination facilities.

Any difficulty arising during the implementation of this Circular should be promptly reported to the Ministry of Health (Drug Administration of Vietnam) for consideration and resolution./.

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