Chapter IV
PROCEDURES FOR VACCINE MARKETING AUTHORIZATION ISSUANCE, RENEWAL, AMENDMENT AND REVOCATION
Article 20. Competence in assessment, issuance, renewal and amendment of vaccine marketing authorizations
1. The Minister of Health shall assign Drug Administration of Vietnam to assess applications for vaccine marketing authorization issuance, renewal and amendment and approve amendments to vaccine marketing authorizations.
2. The Minister of Health shall authorize Head of Drug Administration of Vietnam to issue and renew vaccine marketing authorizations based on application assessment and advice of the advisory board.
Article 21. General provisions
1. General provisions on procedures for vaccine marketing authorization issuance, renewal and amendment are provided in Article 37 of Circular No. 32/2018/TT-BYT.
2. Documents not yet added to the applications mentioned in Articles 18 and 19 of this Circular at the time of application submission may be added while the applications are being assessed and must be fully added before marketing authorization issuance by the applicants. The time where the applicants make such addition shall not count towards the time limit mentioned in Clause 1 Article 22 herein.
Article 22. Procedures for vaccine marketing authorization issuance
1. Within 20 working days after the date of receipt of a sufficient application, Head of Drug Administration of Vietnam shall issue the marketing authorization. If the application is rejected or cannot be approved immediately, Drug Administration of Vietnam shall provide a written explanation. Time limits for these tasks are as follows:
a) Within 02 working days after the date of receipt of the sufficient application, Drug Administration of Vietnam shall send the application to legal experts for assessment of administrative documents, National Institute for Control of Vaccine and Biologicals for assessment of documents on quality and the clinical pharmacology center of Hanoi Medical University for assessment of pharmacological and clinical documents. Within 07 working days after the date of receipt of documents from Drug Administration of Vietnam, the experts and assessment units shall send complete assessment records to Drug Administration of Vietnam for consolidation;
b) Within 03 working days after the date of receipt of the assessment records, Drug Administration of Vietnam shall notify applicants with inadequate applications of the inadequacy in writing. For applications accepted, rejected or requiring assessment and advice from the advisory board, Drug Administration of Vietnam shall send these applications to the board’s office to convene the board or request for the board’s opinions in writing;
c) Within 02 working days after the date of receipt of the documents from Drug Administration of Vietnam, the advisory board’s office shall convene the board or request the board’s members to give their opinions in writing;
d) Within 03 working days after the advisory board convenes, the board’s office shall send complete meeting minutes to Drug Administration of Vietnam;
dd) Within 03 working days after the date of receipt of the meeting minutes, Head of Drug Administration of Vietnam shall decide to issue the marketing authorization for qualified applications; and Drug Administration of Vietnam shall notify applicants with inadequate or rejected applications of the advisory board’s conclusions in writing.
2. For requests for additional documents in notifications sent by Drug Administration of Vietnam, within 36 months (for additional preclinical and clinical documents and stability analysis documents) or within 12 months (for other additional documents) after the notification date, the applicant must submit the required documents. Otherwise, the submitted application will become invalid.
The applicant shall notify Drug Administration of Vietnam of any update related to the vaccine’s safety or effectiveness to the application submitted and undergoing assessment.
The period from the time where Drug Administration of Vietnam issues a notification to the time where the applicant submits additional documents shall not count towards the time limit mentioned in Clause 1 of this Article.
3. Within 15 working days after the date of receipt of sufficient additional documents, Head of Drug Administration of Vietnam shall decide to issue the marketing authorization for qualified applications; and Drug Administration of Vietnam shall notify applicants with inadequate or rejected applications of the advisory board’s conclusions in writing.
Procedures for additional document consideration shall adhere to regulations in Clause 1 herein.
4. In case multiple manufacturing facilities take part in one or more than one part of or the whole manufacturing processes of multiple vaccines and the vaccines are registered using one application as mentioned in Clause 2 Article 5 herein, the vaccines shall be issued with one marketing authorization.
Article 23. Procedures for vaccine marketing authorization renewal
1. Within 18 working days after the date of receipt of a sufficient application, Head of Drug Administration of Vietnam shall renew the marketing authorization. If the application is rejected or cannot be approved immediately, Drug Administration of Vietnam shall provide a written explanation. Time limits for these tasks are as follows:
a) Within 02 working days after the date of receipt of the sufficient application, Drug Administration of Vietnam shall review, classify and send the application to legal experts for assessment of administrative documents and the clinical pharmacology center of Hanoi Medical University for assessment of pharmacological documents. Within 05 working days after the date of receipt of documents from Drug Administration of Vietnam, the experts and assessment unit shall send complete assessment records to Drug Administration of Vietnam for consolidation;
b) Within 03 working days after the date of receipt of the assessment records, Drug Administration of Vietnam shall notify applicants with inadequate applications of the inadequacy in writing. For applications accepted, rejected or requiring assessment and advice from the advisory board, Drug Administration of Vietnam shall send these applications to the board’s office to convene the board or request for the board’s opinions in writing;
c) Within 02 working days after the date of receipt of the documents from Drug Administration of Vietnam, the advisory board’s office shall convene the board or request the board’s members to give their opinions in writing;
d) Within 03 working days after the advisory board convenes, the board’s office shall send complete meeting minutes to Drug Administration of Vietnam;
dd) Within 03 working days after the date of receipt of the meeting minutes, Head of Drug Administration of Vietnam shall decide to renew the marketing authorization for qualified applications; and Drug Administration of Vietnam shall notify applicants with inadequate or rejected applications of the advisory board’s conclusions in writing.
2. For requests for additional documents in notifications sent by Drug Administration of Vietnam, within 12 months after the notification date, the applicant must submit the required additional documents. Otherwise, the submitted application will become invalid.
The applicant shall notify Drug Administration of Vietnam of any update related to the vaccine’s safety or effectiveness to the application submitted and undergoing assessment.
The period from the time where Drug Administration of Vietnam issues a notification to the time where the applicant submits additional documents shall not count towards the time limit mentioned in Clause 1 of this Article.
3. Within 18 working days after the date of receipt of sufficient additional documents, Head of Drug Administration of Vietnam shall decide to renew the marketing authorization for qualified applications; and Drug Administration of Vietnam shall notify applicants with inadequate or rejected applications of the advisory board’s conclusions in writing.
Procedures for additional document consideration shall adhere to regulations in Clause 1 herein.
Article 24. Procedures for amendment to unexpired vaccine marketing authorizations
1. A vaccine marketing authorization shall be amended upon major change to indications, dosage and/or eligibility.
Within 14 working days after the date of receipt of a sufficient application, Drug Administration of Vietnam shall approve the major change to indications, dosage and/or eligibility. If the application is rejected or cannot be approved immediately, Drug Administration of Vietnam shall provide a written explanation. Time limits for these tasks are as follows:
a) Within 02 working days after the date of receipt of the sufficient application, Drug Administration of Vietnam shall send the application to legal experts for assessment of administrative documents, National Institute for Control of Vaccine and Biologicals for assessment of documents on quality and the clinical pharmacology center of Hanoi Medical University for assessment of pharmacological and clinical documents. Within 05 working days after the date of receipt of documents from Drug Administration of Vietnam, the experts and assessment units shall send complete assessment records to Drug Administration of Vietnam for consolidation;
b) Within 02 working days after the date of receipt of the assessment records, Drug Administration of Vietnam shall notify applicants with inadequate applications of the inadequacy in writing. For applications accepted or requiring assessment and advice from the advisory board, Drug Administration of Vietnam shall send these applications to the board’s office to convene the board or request for the board’s opinions in writing;
c) Within 02 working days after the advisory board convenes, the board’s office shall send complete meeting minutes to Drug Administration of Vietnam;
d) Within 03 working days after the date of receipt of the meeting minutes, Drug Administration of Vietnam shall approve qualified applications; and notify applicants with inadequate or rejected applications of the advisory board’s conclusions in writing.
2. Amendment to vaccine marketing authorizations, excluding the cases mentioned in Clauses 1 and 3 of this Article:
Within 10 working days after the date of receipt of a sufficient application, Drug Administration of Vietnam shall approve the change. If the change is rejected or cannot be approved immediately, Drug Administration of Vietnam shall provide a written explanation. Time limits for these tasks are as follows:
a) Within 02 working days after the date of receipt of the sufficient application, Drug Administration of Vietnam shall send the application to legal experts for assessment of administrative documents, National Institute for Control of Vaccine and Biologicals for assessment of documents on quality and the clinical pharmacology center of Hanoi Medical University for assessment of pharmacological and clinical documents. Within 05 working days after the date of receipt of documents from Drug Administration of Vietnam, the experts and assessment units shall send complete assessment records to Drug Administration of Vietnam for consolidation;
b) Within 03 working days after the date of receipt of the assessment records, Drug Administration of Vietnam shall approve qualified applications; and notify applicants with inadequate or rejected applications of the reason for rejection in writing.
3. Amendment to vaccine marketing authorizations upon minor changes that require only notification:
Implement regulations in Point dd Clause 5 Article 1 of Circular No. 29/2020/TT-BYT.
4. For requests for additional documents in notifications sent by Drug Administration of Vietnam, within 36 months (for additional preclinical and clinical documents and stability analysis documents) or within 12 months (for other additional documents) after the notification date, the applicant must submit the required documents. Otherwise, the submitted application will become invalid.
The applicant shall notify Drug Administration of Vietnam of any update related to the vaccine’s safety or effectiveness to the application submitted and undergoing assessment.
The period from the time where Drug Administration of Vietnam issues a notification to the time where the applicant submits additional documents shall not count towards the time limit mentioned in Clause 1 of this Article.
5. Within 07 working days (for applications mentioned in Clause 1 of this Article), 05 working days (for applications mentioned in Clause 2 of this Article) or 03 working days (for applications mentioned in Clause 3 of this Article) after the date of receipt of sufficient additional documents, Drug Administration of Vietnam shall approve amendments to marketing authorizations for qualified applications; and notify applicants with inadequate or rejected applications of the reason for rejection in writing.
Procedures for additional document consideration shall adhere to regulations in Clauses 1 and 2 herein.
6. Time limit for vaccine marketing authorization amendment: no later than 12 months after the date where Drug Administration of Vietnam signs and issues an official dispatch approving the amendment, unless otherwise requested by Drug Administration of Vietnam.
7. The applicant and manufacturing facility shall update the labels and package insert of their vaccine by themselves upon the following changes and are not required to register with or notify Drug Administration of Vietnam for/of these changes:
a) Writing of labels of the vaccine and vaccine ingredients and package insert according to regulations in Clause 2 Article 35 of Circular No. 01/2018/TT-BYT dated January 18, 2018 by the Minister of Health on labeling of drugs, medicinal ingredients and package inserts (hereinafter referred to as “Circular No. 01/2018/TT-BYT”);
b) Revision of content of a label or package insert per a request by Drug Administration of Vietnam;
c) Besides cases where vaccine labels and package inserts must be resubmitted upon change according to regulations in Appendix II of Circular No. 32/2018/TT-BYT, the applicant and manufacturing facility shall update other changes related to information on labels and package insert of their vaccine after Drug Administration of Vietnam approves these changes;
d) Other contents:
- Changes to information on the importing facility or a vaccine ingredient on the labels or package insert;
- Correction of typos on the labels and package insert;
- Change to layout of sections of the package insert without changing content of the approved package insert;
- Addition of information on quality standards to the labels and package insert according to the application approved by Drug Administration of Vietnam;
- Changes made per the notification of results of vaccine registration application assessment from Drug Administration of Vietnam.
Article 25. Applications and procedures for and competence in revocation of vaccine marketing authorizations
Applications and procedures for and competence in revocation of vaccine marketing authorization are provided in Article 42 of Circular No. 32/2018/TT-BYT.
Tìm kiếm
Thông tư 11/2021/TT-BYT (Bản Word)