New: 09 conditions for approval of the first AstraZeneca vaccine in Vietnam

Below is the remarkable content specified in Decision 973/QD-BYT on the conditional approval of vaccines for urgent needs in the prevention of the COVID-19 epidemic in Vietnam.


New: 09 conditions for approval of the first AstraZeneca vaccine in Vietnam (Artwork)

Specifically, in Vietnam's Decision 973/QD-BYT, the Ministry of Health of Vietnam conditionally approved vaccines for urgent needs in the prevention and control of COVID-19 with the COVID-19 vaccine AstraZeneca vaccine of AstraZeneca Co., Ltd. Vietnam (referred to as AZ) according to the provisions of Article 67 of Vietnam's Decree 54/2017/ND-CP. Conditions accompanying the approval of the COVID-19 vaccine AstraZeneca vaccine for urgent needs during the COVID-19 epidemic prevention and control period include:

(1) The COVID-19 vaccine AstraZeneca vaccine was approved based on safety, quality, and efficacy data provided by AstraZeneca Vietnam Co., Ltd. (hereinafter referred to as AZ) to the Ministry of Health of Vietnam as of January 28, 2021; and AZ's commitment that the documents provided to the Ministry of Health of Vietnam are also documents AZ submitted and evaluated by MHRA.

(2) AZ is responsible for promptly responding to requests from the Ministry of Health of Vietnam for additional data or other requests related to the COVID-19 vaccine, AstraZeneca vaccine, and proactively providing and updating new information related to the COVID-19 vaccine, AstraZeneca vaccine, to the Vietnamese Ministry of Health throughout the product development process.

(3) AZ is responsible for ensuring the production conditions at the production facility of the COVID-19 vaccine AstraZeneca Vaccine imported into Vietnam and ensuring the safety, effectiveness, and quality of the imported batch of AstraZeneca Vaccine.

(4) AZ cooperates with the distributor and user of the COVID-19 vaccine, AstraZeneca Vaccine, to deploy a comprehensive pharmacovigilance system for this vaccine in Vietnam in accordance with the law.

(5) AZ must work with the Department of Science, Technology, and Training to conduct clinical trials in Vietnam to assess the safety and immunogenicity of the COVID-19 and AstraZeneca vaccines.

(6) AZ must work with the National Institute for Testing of Vaccines and Medical Biologicals to develop an inspection plan, as well as provide samples, materials, test chemicals, and other related items for testing batches of COVID-19 Vaccine AstraZeneca vaccine before they are used.

(7) AZ must coordinate with the Department of Preventive Medicine in guiding the storage, distribution, and use of the COVID-19 vaccine and AstraZeneca vaccine for vaccination facilities.

(8) AZ must coordinate with the Ministry of Health of Vietnam to implement risk management for the COVID-19 vaccine and AstraZeneca vaccine during their circulation in Vietnam.

(9) The use of COVID-19 vaccine and AstraZeneca vaccine must follow the guidance of the Ministry of Health of Vietnam.

Customers and members can see detailed regulations on the Covid-19 vaccine and the AstraZeneca vaccine at Decision 973/QD-BYT.

Ty Na

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE

91 lượt xem
  • Address: 19 Nguyen Gia Thieu, Vo Thi Sau Ward, District 3, Ho Chi Minh City
    Phone: (028) 7302 2286
    E-mail: info@lawnet.vn
Parent company: THU VIEN PHAP LUAT Ltd.
Editorial Director: Mr. Bui Tuong Vu - Tel. 028 3935 2079
P.702A , Centre Point, 106 Nguyen Van Troi, Ward 8, Phu Nhuan District, HCM City;