Approval process for a potential COVID-19 vaccine in UK

19 November 2020

There are two routes to obtain a COVID-19 vaccine approval: through a full marketing authorization; or through a temporary authorization route known as regulation 174, the UK Medicines and Healthcare products Regulatory Agency (MHRA) explained yesterday.

As regulation 174 is a public health-related measure, manufacturers cannot apply for this authorization, it is the government that requests the MHRA approval for specific products as part of a public health response.

The MHRA will apply the key criteria of safety, quality and efficacy before authorizing the use of a vaccine under either route.

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