Thông tư 11/2021/TT-BYT hướng dẫn đăng ký lưu hành vắc xin Covid19 trường hợp cấp bách

CIRCULAR

PROVIDING GUIDELINES FOR EMERGENCY MARKETING AUTHORIZATION OF COVID-19 VACCINES

Pursuant to the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;

Pursuant to the Law on Technology Transfer No. 07/2017/QH14 dated June 19, 2017;

Pursuant to the Law on Promulgation of Legislative Documents No. 80/2015/QH13 dated June 22, 2015 and Law on Amendments to the Law on Promulgation of Legislative Documents No. 63/2020/QH14 dated June 18, 2020;

Pursuant to Resolution No. 30/2021/NQ-QH15 dated July 28, 2021 of the 15th National Assembly;

Pursuant to the Government's Decree No. 54/2017/ND-CP dated May 08, 2017 elaborating Law on Pharmacy;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 on functions, duties, powers and organizational structure of the Ministry of Health;

Pursuant to the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to some Articles related to business conditions under state management of the Ministry of Health;

Pursuant to the Government’s Resolution No. 86/NQ-CP dated August 06, 2021 on urgent solutions for COVID-19 prevention and control to implement Resolution No. 30/2021/QH15 dated July 28, 2021 by the 15th National Assembly;

At the request of Head of Drug Administration of Vietnam;

The Minister of Health hereby promulgates a Circular providing guidelines for emergency marketing authorization of COVID-19 vaccines.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

This Circular provides for emergency marketing authorization of COVID-19 vaccines (hereinafter referred to as “vaccines"), specifically:

1. Applications and procedures for vaccine marketing authorization issuance, renewal and amendment.

2. Requirements for clinical data in applications to ensure vaccine safety and effectiveness.

3. Exemption from one or more than one clinical trial phase and vaccines required to undergo phase 4 clinical trial in Vietnam.

Article 2. Interpretation of terms

In this Circular, the terms below are construed as follows:

1. “facility transferring vaccine manufacturing technology" refers to the party that owns or has the right to use a vaccine manufacturing technology as per the law and transfers ownership of the technology or right to use the technology to a facility receiving vaccine manufacturing technology to apply it to one or more than one part of or the whole manufacturing process (hereinafter referred to as “transferring facility”).

2. “facility receiving vaccine manufacturing technology" refers to the party that receives ownership of a vaccine manufacturing technology or right to use the technology from a transferring facility under an agreement between two parties to apply it to one or more than one part of or the whole manufacturing process (hereinafter referred to as “receiving facility”).

3. “vaccine with transferred technology" refers to a vaccine manufactured by the receiving facility with one or more than one part of or the whole manufacturing process using the manufacturing technology transferred by the transferring facility under an agreement between two parties.

4. “pre-technology transfer vaccine" means a vaccine which is granted marketing authorization in Vietnam or not yet granted marketing authorization in Vietnam, which is researched and developed in compliance with quality, safety and effectiveness requirements, and the ownership or right to use the manufacturing technology of which is transferred by the transferring facility to the receiving facility to apply it to one or more than one part of or the whole manufacturing process.

Article 3. Rights and responsibilities of vaccine registration applicants, manufacturing facilities, transferring facilities and receiving facilities

1. Vaccine registration applicants (hereinafter referred to as “applicants”) shall have the rights and responsibilities mentioned in Article 57 of the Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016 (hereinafter referred to as “Law on Pharmacy”) and Article 3 of Circular No. 32/2018/TT-BYT dated November 12, 2018 by the Ministry of Health on marketing authorization of drugs and medicinal ingredients (hereinafter referred to as “Circular No. 32/2018/TT-BYT").

2. Vaccine manufacturing facilities (hereinafter referred to as “manufacturing facilities”) shall have the rights and responsibilities mentioned in Article 43 of the Law on Pharmacy and Article 4 of Circular No. 32/2018/TT-BYT.

3. Transferring facilities and receiving facilities shall have the rights and responsibilities mentioned in the Law on Technology Transfer No. 07/2017/QH14 dated June 19, 2017 and relevant guidelines.

4. Applicants shall cooperate with manufacturing facilities in the following tasks:

a) Implement regulations in Clauses 2 and 3 Article 11 and Clause 1 Article 13 of this Circular for vaccines without sufficient clinical data;

b) Develop comprehensive pharmacovigilance systems for their products as per regulations and fully report on adverse events following immunization to General Department of Preventive Medicine;

c) Ensure compliance with risk management plans of their vaccines throughout the product life cycle.

Article 4. Regulations on reporting on monitoring and assessment of safety and effectiveness

1. Pharmacy businesses, healthcare establishments, vaccination facilities and provincial Centers for Disease Control and Prevention (CDCs) must monitor, supervise, collect and consolidate data on, assess and report adverse events following immunization and other relevant information to competent authorities according to regulations in Articles 77 and 78 of the Law on Pharmacy, national guidelines on pharmacovigilance and relevant provisions.

2. Applicants must submit reports on vaccine safety and effectiveness assessment using the form in Appendix 01 enclosed therewith as follows:

a) Submit a report on safety and effectiveness assessment every 02 months during the effective period of the marketing authorization to National DI & ADR Center and General Department of Preventive Medicine;

b) Submit a report when applying to Drug Administration of Vietnam for marketing authorization renewal.

Article 5. Application language, format and quantity

1. Language, format and quantity of vaccine registration applications are provided in Clauses 1, 2, 4 and 5 Article 6 of Circular No. 32/2018/TT-BYT.

2. Multiple vaccines may be registered using one application if they share the following elements: vaccine name, dosage form, administration route, vaccine quality standards and formula, including similar active ingredient concentration or content.

3. Regulations on use of online applications:

a) Application quantity and components: 01 electronic application containing the components required by this Circular shall be submitted online and 01 physical copy of each administrative document (excluding vaccine labels and package insert) shall be submitted to Drug Administration of Vietnam;

b) Applicants and manufacturing facilities may use digital signatures on relevant documents. Digital signatures shall be registered and used according to regulations in the Government’s Decree No. 130/2018/ND-CP dated September 27, 2018 on guidelines for of the Law on E-Transactions of digital signatures and digital signature authentication;

c) Roadmap for application of online documents shall be announced by the Minister of Health.

Article 6. Vaccine registration fees

Applicants shall incur fees related to vaccine registration as per law provisions on fees and charges.

Article 7. Effective period and symbols of vaccine marketing authorization, deadlines for renewal application and for label and package insert registration

1. Effective period and symbols of vaccine marketing authorization and deadline for renewal application are provided in Article 8 of Circular No. 32/2018/TT-BYT.

2. Approved Vietnamese labels and package inserts may exclude commercial packaging of vaccines published on the website of Drug Administration of Vietnam and shall be provided for each vaccination facility to ensure that health officials, healthcare workers and vaccine recipients have full access to approved information.

Article 8. Regulations on verification of information on legal documents

1. Drug Administration of Vietnam shall cooperate with relevant Vietnamese and foreign bodies and diplomatic missions or browse websites in official English database systems provided by competent foreign authorities to verify the following legal documents in vaccine registration applications:

a) Certificates of Pharmaceutical Product (hereinafter referred to as “CPP") or substitute legal documents mentioned in Point d Clause 2 Article 15 of this Circular in applications for vaccine marketing authorization issuance, renewal and amendment;

b) Legal documents issued by competent foreign authorities of foreign applicants applying for drug registration for the first time in Vietnam.

2. Vaccine registration applications shall be verified and assessed at the same time and results of legal document verification according to Clause 1 of this Article must be available before the marketing authorization is issued, renewed or amended.

Article 9. Organization and operation of marketing authorization advisory board

Organization and operation of marketing authorization advisory board (hereinafter referred to as “advisory board”) are provided in Article 44 of Circular No. 32/2018/TT-BYT.

Article 10. Organization and operation of vaccine registration application assessors

Organization and operation of vaccine registration application assessors are provided in Article 45 of Circular No. 32/2018/TT-BYT.

Chapter II

REQUIREMENTS FOR CLINICAL DATA TO ENSURE SAFETY AND EFFECTIVENESS, ELIGIBILITY FOR EXEMPTION FROM ONE OR MORE THAN ONE CLINICAL TRIAL PHASE, AND VACCINES REQUIRING PHASE 4 CLINICAL TRIAL IN VIETNAM

Article 11. Regulations on clinical data in applications for vaccine marketing authorization

1. Requirements for clinical data for safety and effectiveness assurance in applications for vaccine marketing authorization are provided in Points a and b Clause 1 Article 13 of Circular No. 32/2018/TT-BYT.

2. For vaccines manufactured at a manufacturing site or manufacturing facility different from where vaccines used in the clinical trial are manufactured, applicants may use clinical data of vaccines used in the clinical trial and shall prove that the change of manufacturing site or manufacturing facility does not affect vaccine quality. If the applicant or manufacturing facility does not own clinical data or is not affiliated to the same corporation as the clinical data owner, clinical data must be used with permission from its owner.

After being granted marketing authorization, the applicant shall cooperate with the manufacturing facility in further evaluating vaccine safety and immunogenicity on the target population in Vietnam during use according to guidelines of the Ministry of Health (Administration of Science Technology and Training) if the vaccine has not been authorized by a Strengthening Regulatory Authority (SRA) mentioned in Clause 10 Article 2 of Circular No. 32/2018/TT-BYT.

3. For vaccines which are manufactured in Vietnam and undergoing clinical trials, if phase 3 interim assessment results for safety and protection effectiveness based on immunogenicity data are available, these results may be used to apply for conditional granting of marketing authorization based on advice of the national research ethics committee (for drugs and vaccines undergoing clinical trials in Vietnam) and advice of the advisory board for each vaccine and with reference to WHO guidelines or recommendations.

Vaccines granted marketing authorization in the abovementioned cases are subject to further monitoring of their safety, effectiveness, recipients, dosage and scope of use after they are granted marketing authorization.

After granted marketing authorization, the applicant shall cooperate with the manufacturing facility in further clinical research and clinical data update in compliance with guidelines of the Ministry of Health (Administration of Science Technology and Training).

Article 12. Requirements for clinical data of vaccines granted marketing authorization in Vietnam upon revision of clinical data in approved vaccine registration applications

For vaccines granted marketing authorization in Vietnam, upon revision of clinical data in approved vaccine registration applications, applicants shall provide additional clinical data in compliance with regulations in Appendix II of Circular No. 32/2018/TT-BYT or ICH-CTD (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Common Technical Document (CTD)) or guidance of United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) or WHO.

Article 13. Exemption from one or more than one clinical trial phase when applying for marketing authorization

The Minister of Health may consider and decide to exempt vaccines not meeting the requirements mentioned in Clause 1 Article 11 herein from one or more than one clinical trial phase (including clinical data reduction or exemption) based on advice of the advisory board in any of the following cases:

1. The vaccine has been authorized by at least one country and has clinical data on its safety and effectiveness.

In case the pharmaceutical authority of the authorizing country is not one of the regulatory bodies mentioned in Clause 10 Article 2 of Circular No. 32/2018/TT-BYT, after granted marketing authorization, the applicant shall cooperate with the manufacturing facility in further assessing the vaccine’s safety and immunogenicity on the target population in Vietnam during use according to guidelines of the Ministry of Health (Administration of Science Technology and Training).

2. The vaccine is manufactured in Vietnam using transferred technology for one or more than one part of or the whole manufacturing process and, prior to the technology transfer, the vaccine has clinical data on safety and effectiveness and is authorized by at least one country.

Article 14. Cases requiring phase 4 clinical trial in Vietnam

Based on advice from the advisory board, vaccines granted marketing authorization but needing further safety and effectiveness assessment must undergo phase 4 clinical trial in Vietnam.

Chapter III

APPLICATIONS FOR VACCINE MARKETING AUTHORIZATION ISSUANCE, RENEWAL AND AMENDMENT

Article 15. Regulations on documents in applications for vaccine marketing authorization issuance, renewal and amendment

1. Documents in applications for vaccine marketing authorization issuance, renewal and amendment are provided for in Clauses 1, 2, 3, 7, 8, 9, 10, 11 and 15 Article 23 of Circular No. 32/2018/TT-BYT and Points a and l Clause 5 Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020 by the Ministry of Health on amendments to and abrogation of some legislative documents promulgated or jointly promulgated by the Minister of Health (hereinafter referred to as “Circular No. 29/2020/TT-BYT”).

2. Regulations on CPP:

a) CPP must have a signature, name of the signer, issuance date and seal of the issuer;

b) CPP must be issued by a pharmaceutical authority.

If CPP is not issued by a pharmaceutical authority, the applicant shall provide documentary proof that the issuer has competence for such issuance and the pharmaceutical authority of that country does not issue CPP as per the law of that country;

c) CPP must include all information mentioned in Appendix 02 enclosed therewith. Appendixes to CPP (if any) shall be verified by the issuer;

d) If an imported vaccine does not have CPP, this certificate may be replaced by a legal document issued by the competent authority of the export country proving that the vaccine has been granted marketing authorization and containing the following basic information: vaccine name, active ingredients, active ingredient concentration or content, dosage form, name and address of manufacturing facility and confirmation that the vaccine is authorized in that country.

CPPs of vaccines manufactured by multiple manufacturing facilities or substitute legal documents must specify the name, address and role of each facility.

3. Applications shall be formulated using the forms in Appendix 03 enclosed therewith. Other relevant administrative documents must be signed and stamped by the legal representative or authorized person of the legal representative of the applicant instead of using a signature stamp.

4. Letters of authorization shall be made using the forms in Appendix 04 enclosed therewith. An application shall include one authentic copy or copy with confirmation seal of the applicant or representative office (for foreign applicants) of the letter of authorization in the following cases:

a) Applicant authorization using the form in Appendix 04A enclosed therewith;

b) Authorization of application signing using the form in Appendix 04B enclosed therewith; if the person authorized to sign the application is not the head of the representative office, the letter of authorization must bear the seal and countersignature of the head of the representative office in Vietnam (for foreign applicants).

5. Submit authentic copies with the signature and confirmation seal of the manufacturing facility of quality standards, analyzing methods, certificates of analysis and stability analysis documents (included in documents on active ingredients and finished products); or copies with confirmation seal of the applicant (seal of the representative office is acceptable for foreign vaccines) of these documents.

If the manufacturing facility does not use a seal as per regulations of its home country, the confirmation seal is not required. In this case, the applicant shall provide a confirmation seal, guarantee that the manufacturing country does not use the required seal and take responsibility for the honesty of the abovementioned documents.

A certificate of analysis must include the following information: administrative information (name and address of manufacturing facility, name and signature of person in charge and date of certificate signing) and information on samples of the vaccine and vaccine ingredients (product name, batch number, expiry date, applied quality standards, quality criteria, quality requirements, analysis results and conclusion about batch quality).

Article 16. Documents on quality in applications for vaccine marketing authorization issuance and amendment

Documents on quality shall adhere to regulations in Clause 7 Article 25 of Circular No. 32/2018/TT-BYT, guidelines in Part II of ASEAN Common Technical Document (ACTD) or Module 3-ICH-CTD and the following regulations:

1. Batch release certificate shall be issued by an analyzing unit appointed by the competent authority of the manufacturing country.

2. In case the applicant cannot provide the document mentioned in Clause 1 of this Article, the applicant shall provide certificates of analysis, quality standards and analyzing methods confirmed by analyzing units appointed by the competent authority of the manufacturing country according to regulations in Clause 5 Article 1 of Circular No. 03/2020/TT-BYT dated January 22, 2020 by the Minister of Health on amendments to some Articles of the Circular No. 11/2018/TT-BYT dated May 04, 2018 of the Minister of Health on quality of pharmaceutical products and pharmaceutical starting materials.

3. Documents on manufacturing process assessment and stability analysis must include data on 03 commercial-sized batches.

If data on 03 commercial-sized batches cannot be provided, provide data on at least 01 commercial-sized batch and 02 pilot-sized batches (at least 1/10 of the commercial size) and comparison table for manufacturing processes and stability analyses of commercial-sized batch(s) and pilot-sized batches, vaccine batches used in the clinical trial and certificate of analysis of each batch.

4. Regarding documents on quality of vaccines with transferred technology that have unexpired Vietnamese marketing authorizations when they are pre-technology transfer vaccines

Documents on quality of vaccines with transferred technology shall comply with the guidelines in Clauses 1, 2 and 3 of this Article and include the following documents:

a) Comparison table for differences (if any) between the pre-technology transfer vaccine and vaccine with transferred technology and documentary proof according to regulations in Appendix II to Circular No. 32/2018/TT-BYT and Clause 2 Article 18 of this Circular;

b) Documents on active ingredients of the vaccine with transferred technology provided by the receiving facility upon change of an active ingredient manufacturing facility of the pre-technology transfer vaccine;

c) Documents of the finished product of the vaccine with transferred technology shall be formulated by the receiving facility and include the following documents:

- Report on manufacturing process assessment (for manufacturing stages done at the receiving facility);

- Report on assessment of suitability of analyzing procedure (may be replaced by documents on analyzing procedure transfer formulated by the transferring facility and receiving facility);

- Data on batch analysis and certificate of analysis of the finished product.

5. If the pre-technology transfer vaccine has not been granted Vietnamese marketing authorization or its Vietnamese marketing authorization has expired, documents on quality of the vaccine with transferred technology shall adhere to the guidelines in Clause 4 of this Article and documents on quality of the pre-technology transfer vaccine shall comply with the guidelines in Part II-ACTD or Module 3-ICH-CTD.

6. For vaccines undergoing secondary packaging in Vietnam

All documents on vaccine quality prior to secondary packaging in Vietnam shall conform to Part II-ACTD or Module 3-ICH-CTD and Clauses 1, 2 and 3 of this Article if the vaccine has not been granted Vietnamese marketing authorization or its Vietnamese marketing authorization expires prior to secondary packaging in Vietnam.

Article 17. Preclinical and clinical documents in applications for vaccine marketing authorization issuance and amendment

1. Preclinical documents shall follow the guidelines in Part III-ACTD or Module 4-ICH-CTD.

2. Clinical documents shall follow the guidelines in Part IV-ACTD or Module 5-ICH-CTD.

Article 18. Applications for vaccine marketing authorization issuance, renewal and amendment

1. Applications for vaccine marketing authorization issuance, renewal and amendment are provided for in Clauses 1, 3 and 4 Article 28 of Circular No. 32/2018/TT-BYT and Articles 15 and 16 of this Circular and shall include the following documents:

a) For multiple vaccines registered using one application according to regulations in Clause 2 Article 5 herein, documents on quality must be prepared for each single-dose and multi-dose packaging specification and for each involved manufacturing facility as per regulations of this Circular;

b) For vaccines with change of manufacturing site or manufacturing facility according to regulations in Clause 2 Article 11 herein:

- Letter of authorization of the clinical data owner, which allows the manufacturing facility or applicant to use the clinical data, in case the applicant or manufacturing facility does not own the clinical data or is not affiliated to the same corporation as the clinical data owner;

- Documentary proof that change of manufacturing site or manufacturing facility does not affect vaccine quality.

2. In case of applying for amendment to a matter not provided for in Appendix II to Circular No. 32/2018/TT-BYT (including update of virus mutation), the applicant shall classify and submit technical documents following guidelines of USFDA, EMA, MHRA or WHO.

Article 19. Applications for vaccine marketing authorization issuance, renewal and amendment for vaccines with transferred technology and vaccines undergoing secondary packaging

1. Vaccines with transferred technology must meet all of the following requirements:

a)  Vaccine manufacturing technology transfer involves transfer of technology for one or more than one part of or the whole vaccine manufacturing process to the receiving facility. Transfer of secondary packaging technology shall not be considered as vaccine manufacturing technology transfer.

b) The vaccine with transferred technology and pre-technology transfer vaccine must meet all of the following criteria:

- The two vaccines have the same formula;

- The two vaccines have the same manufacturing facility, quality standards and analyzing procedures for active ingredients;

- Excipients of the two vaccines have the same quality standards and analyzing procedures;

- Excipients of the two vaccines have the same quality standards and analyzing procedures;

c) In case there is a difference between the vaccine with transferred technology and pre-technology transfer vaccine according to regulations in Point a of this Clause, implement the guidelines in Appendix II to Circular No. 32/2018/TT-BYT and regulations in Clause 2 Article 18 of this Circular.

2. An application for issuance of marketing authorization to a vaccine with transferred technology when the pre-technology transfer vaccine has an unexpired Vietnamese marketing authorization shall include:

a) Administrative documents:

Administrative documents shall adhere to the regulations in Points a and b Clause 1 Article 18 of this Circular and include the following documents:

- Administrative documents mentioned in Point a Clause 5 Article 28 of Circular No. 32/2018/TT-BYT, excluding the application and letter of authorization (if any), which shall be made using the forms in Appendix 03 and Appendix 04 enclosed therewith respectively;

- Good manufacturing practice certificate of the receiving facility whose scope is suitable for the manufacturing of the vaccine with transferred technology;

- Certificate of technology transfer registration for technology transfer cases mentioned in Clause 1 Article 31 of the Law on Technology Transfer.

b) Documents on quality, which shall be formulated according to the regulations in Clause 4 Article 16 of this Circular;

c) Preclinical and clinical documents, which shall be formulated according to the regulations in Article 17 of this Circular.

3. An application for issuance of marketing authorization to a vaccine with transferred technology when the pre-technology transfer vaccine does not have a Vietnamese marketing authorization or its Vietnamese marketing authorization has expired shall include:

a) Administrative documents:

Administrative documents shall adhere to the regulations in Points a and b Clause 1 Article 18 of this Circular and include the following documents:

- Administrative documents mentioned in Point b Clause 5 Article 28 of Circular No. 32/2018/TT-BYT, excluding the application and letter of authorization (if any), which shall be made using the forms in Appendix 03 and Appendix 04 enclosed therewith respectively;

- Legal documents substituting CPP mentioned in Point d Clause 2 Article 15 of this Circular if the pre-technology transfer vaccine is a foreign vaccine (if applicable);

- Good manufacturing practice certificate of the receiving facility whose scope is suitable for the manufacturing of the vaccine with transferred technology;

- Certificate of technology transfer registration for technology transfer cases mentioned in Clause 1 Article 31 of the Law on Technology Transfer.

b) Documents on quality, which shall be formulated according to the regulations in Clause 5 Article 16 of this Circular;

c) Preclinical and clinical documents, which shall be formulated according to the regulations in Article 17 of this Circular;

d) Documents on the pre-technology transfer vaccine, including documents of the pre-technology transfer vaccine mentioned in Clause 1 Article 18 of this Circular.

If the pre-technology transfer vaccine is not applying for marketing authorization, the label expected to be used in Vietnam is not required.

4. Applications for marketing authorization of vaccines undergoing secondary packaging in Vietnam shall be formulated according to regulations applicable to change of secondary packaging facility in Appendix II to Circular No. 32/2018/TT-BYT if these vaccines have unexpired Vietnamese marketing authorizations prior to secondary packaging.

5. An application for issuance of marketing authorization to a vaccine undergoing secondary packaging in Vietnam if this vaccine does not have a Vietnamese marketing authorization or its Vietnamese marketing authorization has expired prior to secondary packaging shall adhere to the regulations in Points a and b Clause 1 Article 18 of this Circular and include the following documents:

a) Administrative documents mentioned in Point b Clause 6 Article 28 of Circular No. 32/2018/TT-BYT, excluding the letter of authorization (if any), which shall be made using the form in Appendix 04 enclosed therewith;

b) Documents on quality, which shall be formulated according to the regulations in Clause 6 Article 16 of this Circular.

6. Regarding applications for marketing authorization renewal or amendment for vaccines with transferred technology or undergoing secondary packaging in Vietnam:

Applications for vaccine marketing authorization renewal or amendment of vaccines with transferred technology or undergoing secondary packaging shall be formulated according to regulations in Clauses 3 and 4 Article 28 of Circular No. 32/2018/TT-BYT and Article 15 of this Circular. For application for amendment to contents not included or provided in Appendix II to Circular No. 32/2018/TT-BYT (including updates on virus mutations), the applicant shall submit technical documents in compliance with guidelines of USFDA, EMA, MHRA or WHO.

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.

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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