Freedom of Information request (FOI 22/952)
Published 17 January 2024
© Crown copyright 2024
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-24-october-2022/freedom-of-information-request-foi-22952
FOI 22/952
25th October 2022
Dear
Thank you for your email.
There are no conversions of the authorisations of vaccine products under Regulation 174 to marketing authorisations. Authorisations under Regulation 174 were intended for the use of specific batches of vaccine products during the vaccine rollout. The authorisations under Regulation 174 still exist; however, as the specific batches of vaccine authorised under Regulation 174 are used, these will become obsolete.
For information, none of the R174 emergency use authorisations have been withdrawn (although R174 product can no longer be supplied in the UK).
We confirm that the vaccines are licensed. A Conditional Marketing Authorisation (CMA) is a licence.
All the COVID-19 vaccines have conditional MAs and as the conditions get fulfilled, the CMAs get converted into standard MAs. The EMA has already converted the Comirnaty CMA and the Spikevax CMA into standard MAs and they apply in Northern Ireland. The equivalent change may be made in GB in due course.
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