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Ministry of health |
SOCIALIST
REPUBLIC OF VIETNAM |
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No. 457/QD-BYT |
Hanoi, March 01, 2022 |
DECISION
On amendments to Article 1 of Decision No. 2908/QD-BYT dated June 12, 2021 of the minister of Health on conditioned approval for vaccines serving urgent needs in 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 Law on Pharmacy No. 105/2016/QH13 dated April 06, 2016;
Pursuant to Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 providing detailed regulations on some articles and implementation measures of the Law on Pharmacy;
Pursuant to Decree No. 155/2018/ND-CP dated November 12, 20218 of the Government on amendments to certain regulations related to requirements for trading and investment under state management of the Ministry of Health;
Pursuant to Decree No. 104/2016/ND-CP dated July 01, 2016 of the Government on vaccination;
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Pursuant to Decision No. 447/QD-TTg dated April 01, 2020 of the Prime Minister on publication of COVID-19 epidemic;
Pursuant to proposals of Consultancy Board on granting Registrations for Free Sale of drugs and drug materials specified in Official Dispatch No. 05/HDTV-VPHD dated January 11, 2022 and No. 16/HDTV-VPHD dated February 16, 2022;
At the request of the General Director of Drug Administration of Vietnam.
HEREBY DECIDES:
Article 1. Amendments to Article 1 of Decision No. 2908/QD-BYT dated June 12, 2021 of the Minister of Health on conditioned approval for vaccines serving urgent needs in covid-19 prevention and control:
“Article 1. Conditioned approval for vaccines serving urgent needs in COVID-19 prevention and control according to regulations in Article 67 of Decree No. 54/2017/ND-CP dated May 08, 2017 of the Government providing detailed regulations on some articles and implementation measures of the Law on Pharmacy (Decree No. 54/2017/ND-CP). To be specific:
1. Vaccine name: Comirnaty (also known as Pfizer BioNTech Covid-19 Vaccine).
2. Active ingredients and concentration/content:
a) Regarding vaccines for people aged 12 and older:
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b) Regarding vaccines for children aged from 5 to 12;
Each 0.2 ml dose contains 10 mcg of Covid-19 mRNA vaccine (encased in lipid nanoparticles)."
3. Dosage Form:
a) Regarding vaccines for people aged 12 and older:
- Concentrated suspension for injection;
- Injectable suspension.
b) Regarding vaccines for children aged from 5 to 12;
- Concentrated suspension for injection;
4. Package specification:
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- 1 tray contains 195 vials; each vial contains 6 doses;
- 1 container holds 25 vials; each vial contains 6 doses;
- 1 container holds 10 vials; each vial contains 6 doses;
b) Regarding vaccines for children aged from 5 to 12;
- 1 tray contains 195 vials; each vial contains 10 doses;
- 1 container holds 10 vials; each vial contains 10 doses;
5. Name of manufacturers and manufacturing countries;
- Pfizer Manufacturing Belgium NV - Belgium;
- BioNTech Manufacturing GmbH – Germany;
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- Hospira Incorporated (Alternative spelling: Hospira Inc.) – United State.
6. Name of manufacturer requesting vaccine approval: Pfizer (Vietnam) Limited Company".
Article 2. This Decision comes into force from the date on which it is signed. Annul Decision No. 4035/QD-BYT dated August 21, 2021 of the Minister of Health on addition to Article 1of Decision No. 2908/QD-BYT dated June 12, 2021 of the Minister of Health on conditioned approval for vaccines serving urgent needs in covid-19 prevention and control.
Article 3. Chief of Office of the Ministry; Director of the Drug Administration of Vietnam; Director General of the Department of Science, Technology and Training; Director of the Department of Preventive Medicine; Director of the Department of Planning and Finance; Director of the Legal Department; Director of the National Institute of Hygiene and Epidemiology, Director of the National Accreditation Institute of Vaccines and Medical Bio-products; General Director of Pfizer (Vietnam) Limited Company and Heads of relevant units are responsible for implementing this Decision./.
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen