FOI release

Freedom of Information request on the approval status for Paxlovid and Molnupiravir (FOI 22/516)

Published 31 May 2022

FOI 22/516

4th March 2022

Dear

Thank you for your email.

Please find below the answer to your question below.

Paxlovid and molnupiravir hold both a CMA in Great Britain (GB) and a Northern Ireland (NI)-only R174 authorisation. This was to ensure supply of the therapeutics to NI, as the MHRA authorised this before the European Medicines Agency (EMA) (and NI is subject to EMA licensing decisions).

If you have a query about the information provided, please reply to this email.

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