Freedom of Information request on the authorisation of the vaccines under Regulation 174 (FOI 21/944)
Published 17 January 2022
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13th September 2021
FOI 21/944 Dear
Thank you for emails of 06 and 11 August.
We have previously supplied you links to the Public Assessment Reports (PARs) for the authorisation of the vaccines under Regulation 174. As we had supplied these to you previously we did not send them again, instead we focused on and supplied links to the EMA PARs which contain the assessment of the vaccines for the grant of the marketing authorisations.
You have asked regarding the documentation required to be submitted. The same quality, non-clinical and clinical data is required for an application under the Rolling Review process as would be required for the grant of a marketing authorisation.
The documentation required is set out in the ‘International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use’, which can be accessed via the link below. The non-clinical and clinical studies that were submitted for the MHRA’s assessment of each vaccine are stated in the PAR for each authorised vaccine.
eCTD specification 3.2.2 (ich.org)
Kind regards,
MHRA Customer Service Centre