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The Ministry of Health of Vietnam: Requirements for approval of the first COVID-19 vaccine

Lê Hải

11:16, 01/02/2021

Recently, the Ministry of Health of Vietnam has issued Decision 973/QD-BYT on the conditional approval of vaccines for urgent needs in the prevention of the COVID-19 epidemic.

According to Vietnam's Decision 973/QD-BYT, 09 conditions for approving the COVID-19 vaccine - AstraZeneca include:

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 28/28. 01/2021 and AZ's commitment that the documents provided to the Ministry of Health of Vietnam are also documents AZ submitted and evaluated by MHRA;
AZ is responsible for promptly responding to requests from the Vietnamese Ministry of Health for additional data or other requests related to the AstraZeneca COVID-19 vaccine and proactively providing and updating information related to the COVID-19 vaccine AstraZeneca vaccine for the Ministry of Health of Vietnam during product development;
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 COVID-19 vaccine to Vietnam;
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More details can be found in Vietnam's Decision 973/QD-BYT issued on January 31, 2021.

>> CLICK HERE TO READ THIS ARTICLE IN VIETNAMESE

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