Freedom of Information request (FOI 22/1024)
Published 17 January 2024
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19th October 2022
FOI 22/1024
Dear
Thank you for your request under FOIA in which you asked for details of the formal approvals process before the next generation mRNA vaccines and treatments can be rolled out for use in the human population.
Please note, we do not have a process specific to COVID-19 vaccine authorisation and as such, this is a data not held response under FOIA.
The authorisation process is the same for all vaccines and indeed all medicines. However, there does exist some guidance about the licensing process on our website
There is international harmonisation on the technical Requirements for Pharmaceuticals for Human Use compiled an published by ICH.
This website has a set of guidelines on all aspects of authorisation, e.g. quality requirements on impurities, product stability, analytical methods, etc, and there are a set of guidelines on efficacy and on safety.
In terms of Temporary Authorisation under Regulation 174, these requests arrive from the Secretary of State so we cannot confirm whether or not R174 will be requested for future applications related to COVID-19 medicines (including vaccines).
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF
Yours sincerely
MHRA Customer Experience Centre