MINISTRY OF
HEALTH
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SOCIALIST REPUBLIC
OF VIETNAM
Independence - Freedom - Happiness
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No. 1654/QD-BYT
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Hanoi, March 23,
2021
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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;
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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.
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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.
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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./.
P.P. THE
MINISTER
THE DEPUTY MINISTER
Truong Quoc Cuong
APPENDIX
CONDITIONS FOR APPROVING GAM-COVID-VAC VACCINE FOR URGENT
COVID-19 PREVENTION AND CONTROL
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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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