Quyết định 1654/QĐ-BYT năm 2021 phê duyệt có điều kiện vắc xin cho nhu cầu cấp bách trong phòng, chống dịch bệnh COVID-19 do Bộ Y tế ban hành

DECISION

ON CONDITIONAL VACCINE APPROVAL FOR URGENT COVID-19 PREVENTION AND CONTROL

MINISTER OF HEALTH

Pursuant to the Law on Prevention and Control of Infectious Diseases No.03/2007/QH12 dated November 21, 2007;

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

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. 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 Decree No. 104/2016/ND-CP dated July 01, 2016 on vaccination;

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 Prime Minister’s Decision No. 447/QD-TTg dated April 01, 2020 on COVID-19 epidemic declaration;

Pursuant to proposals of the advisory council for granting of marketing authorization to vaccines and biologicals in the meeting on February 25, 2021 on data on vaccine quality, safety and effectiveness provided by Center for Research and Production of Vaccines and Biologicals;

At the request of Director Generals of General Department of Preventive Medicine, Drug Administration of Vietnam and Administration of Science Technology and Training,

HEREBY DECIDES:

Article 1. Conditional approval is granted to the following vaccine, which is used for urgent COVID-19 prevention and control, according to regulations in Article 67 of the Government's Decree No. 54/2017/ND-CP dated May 08, 2017 elaborating Law on Pharmacy (hereinafter referred to as “Decree No. 54/2017/ND-CP”):

1. Vaccine name: Gam-COVID-Vac (also known as SPUTNIK V).

2. Active ingredient and concentration/content:

- Component I (first dose): each dose of 0,5ml contains (1,0 ± 0,5) x 1011 particles of recombinant human adenovirus serotype number 26 containing SARS-CoV-2 protein S gene.

- Component II (second dose): each dose of 0,5ml contains (1,0 ± 0,5) x 1011 particles of recombinant human adenovirus serotype number 5 containing SARS-CoV-2 protein S gene.

3. Dosage form: injection solution.

4. Packaging specification: each box shall contain 1 vial of 3ml (equivalent to 5 doses).

5. Manufacturer - manufacturing country: JSC Generium - Russia.

6. Vaccine approval applicant: Center for Research and Production of Vaccines and Biologicals (POLYVAC).

Article 2. Conditions for approving Gam-COVID-Vac vaccine for urgent COVID-19 prevention and control are provided in the Appendix enclosed therewith.

Article 3. Responsibilities:

1. Drug Administration of Vietnam shall:

a) Grant permits for Gam-COVID-Vac vaccine import according to regulations in Article 67 of Decree No. 54/2017/ND-CP after receiving applications from importers.

b) Comply with regulations of law on import management and imported vaccine quality control.

2. Administration of Science Technology and Training shall take charge of clinical evaluation of the safety and immunogenicity of Gam-COVID-Vac vaccine in Vietnam.

3. General Department of Preventive Medicine shall take responsibility for matters concerning administration of the Gam-COVID-Vac vaccine according to regulations in Decision No. 1464/QD-BYT dated 05/03/2021 by the Minister of Health on guidelines for receiving, preserving, distributing and using COVID-19 vaccine and Decision No. 1467/QD-BYT dated 05/03/2021 by the Minister of Health approving 2021 - 2022 COVID-19 vaccination plan.

4. National Institute for Control of Vaccine and Biologicals shall inspect the Gam-COVID-Vac vaccine before it is put to use.

Article 4. This Decision takes effect from the date on which it is signed.

Article 5. Head of Office of the Ministry of Health; heads of Drug Administration of Vietnam, Administration of Science Technology and Training, General Department of Preventive Medicine, Department of Planning and Finance and Department of Legal Affairs; Director of POLYVAC; and heads of relevant units shall implement this Decision./.

APPENDIX

CONDITIONS FOR APPROVING GAM-COVID-VAC VACCINE FOR URGENT COVID-19 PREVENTION AND CONTROL

(Enclosed with Decision No. 1654/QD-BYT dated March 23, 2021 by Minister of Health)

1. Gam-COVID-Vac vaccine shall be approved based on safety, quality and effectiveness data provided by Center for Research and Production of Vaccines and Biologicals (POLYVAC) for the Ministry of Health of Vietnam up to 25/02/2021 and POLYVAC’s commitment about the accuracy of documents provided for the Ministry of Health of Vietnam.

2. POLYVAC shall cooperate with the vaccine manufacturer in promptly responding to requests for additional data or other requests related to the Gam-COVID-Vac vaccine from the Ministry of Health of Vietnam and proactively updating the Ministry of Health of Vietnam on new information regarding the Gam-COVID-Vac vaccine throughout the product development process.

3. POLYVAC shall cooperate with the manufacturer in fulfilling conditions for the manufacturing of Gam-COVID-Vac vaccine batches to be imported to Vietnam and ensuring the safety, effectiveness and quality of Gam-COVID-Vac vaccine batches imported to Vietnam.

4. POLYVAC shall cooperate with units in charge of distributing and using the Gam-COVID-Vac vaccine in deploying a comprehensive pharmacovigilance system for this vaccine in Vietnam as prescribed by law.

5. POLYVAC must cooperate with Administration of Science Technology and Training in the clinical evaluation of the safety and immunogenicity of Gam-COVID-Vac vaccine in Vietnam.

6. POLYVAC must cooperate with National Institute for Control of Vaccine and Biologicals in formulation of an inspection plan, provision of samples, testing chemicals and raw materials and other matters concerning inspection of Gam-COVID-Vac vaccine batches before they are put to use.

7. POLYVAC must cooperate with National Institutes of Hygiene and Epidemiology in providing guidelines on storage, distribution and use of the Gam-COVID-Vac vaccine for vaccination facilities.

8. POLYVAC must cooperate with the Ministry of Health of Vietnam in risk management concerning the Gam-COVID-Vac vaccine when the vaccine is used in Vietnam.

9. The Gam-COVID-Vac vaccine must be used in compliance with guidelines of the Ministry of Health of Vietnam.

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