Covid Jab: What Does Temporary Use Authorisation Mean?

Recommended by a reader. There are some lies in the article, about the size of the trials and how effective the vaccines are, but the legal rules may be useful.

Temporary use authorisations under HMR 2012 permit the supply of an unlicensed medicinal product for use in response to certain specific types of public health threat, including in response to the suspected or confirmed spread of pathogenic agents

Subject to narrowly defined exceptions, all medicines must obtain a marketing authorisation from the MHRA or European Medicines Agency (EMA) (depending upon the licensing approval route) before that medicine can be placed on the market. Prior to obtaining regulatory approval, sufficient evidence on the safety, quality and efficacy of the product must be demonstrated. There are similar requirements for applicants for temporary use authorisations.

A product granted a temporary use authorisation is not a licensed product in regulatory terms. Its permitted use is authorised for a fixed period and the product remains subject to any conditions stipulated by the MHRA.

Read the full article: https://brodies.com/insights/healthcare-and-life-sciences/the-mechanics-of-medicines-regulation-shining-a-spotlight-on-the-mhra-vaccine-approval-decision/

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