Chris Seeks Reasons For The Removal Of CMA Authorisation Conditions for Comirnaty
Christopher Chope Conservative, Christchurch
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 7 November 2022 to Question 77274 on Coronavirus: Vaccination, if he will make an assessment of the compatibility of the conditional marketing authorisation (CMA) for the Comirnaty vaccine with the requirement that such authorisations will expire after one year and are extendable upon evaluation for a further year; for what reason the post-authorisation conditions for the CMA for Comirnaty were removed from the Government’s website on 9 November 2022; and if he will make a statement.
Neil O'Brien The Parliamentary Under-Secretary for Health and Social Care
The post-authorisation conditions relating to any Conditional Marketing Authorisations (CMA) are only removed from the licence once these conditions have been met and a full Marketing Authorisation (MA) could then be considered. Where clinical studies are continuing, companies will update to the regulatory authorities through post-authorisation measures.
As there are no further specific obligations, the status changed from CMA to MA for the following Comirnaty products on 9 November 2022:
- Comirnaty 30 micrograms/dose Concentrate for Dispersion for Injection (PLGB 53632/0002);
- Comirnaty 30 micrograms/dose Dispersion for Injection (PLGB 53632/0004); and
- Comirnaty 10 micrograms/dose Concentrate for Dispersion for Injection (PLGB 53632/0006).
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Please CLICK HERE for the previous referenced Written Question
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