FOI release

Freedom of Information request on the PARs are available on the MHRA website for all MAs granted via national and European procedures (FOI 21/575)

Published 1 June 2022

FOI 21/575

24th March 2022

Dear

Thank you for your email.

Public Assessment Reports (PARs) are prepared for all new marketing authorisations (MAs) granted after 31 October 2005. These PARs are available on the MHRA website for all MAs granted via national and European procedures where the UK was Reference Member State (RMS), on the European Medicines Agency website for all MAs granted via Centralised procedures, and on other member state websites for MAs granted via European procedures where the UK is a Concerned Member State (CMS).  As the date for the end of procedure predates when the UK was required to prepare PARs for marketing authorisations, no PARs have been published for these products and none are available.

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

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Due to the ongoing Pandemic situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices

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

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 0203 080 6000