FOI release

Freedom of Information request about ATMP products (FOI-21-073)

Published 7 May 2021

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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-8-march-2021/freedom-of-information-request-about-atmp-products-foi-21-073

10th March 2021 FOI 21/073

Dear

Thank you for your Freedom of Information (FOI) request, dated 10 February 2021, where you asked for “clarification from the MHRA on the following:

  1. As of today’s date how many ATMP products are authorised/approved for sale/supply on the UK market and;

  2. Of those authorised/approved, how many are reimbursed. If this is not a question for the MHRA can you please direct me to the correct government department so that I can accurately report”

I can confirm that the MHRA does hold some of the information that you have requested. However, we have also determined that the information is exempt under Section 12 of the FOI Act (unreasonable use of resources) and we cannot process your request any further.

Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at 24 working hours in determining whether the department holds the information, and locating, retrieving and extracting the information. In order to provide an answer to the above questions, MHRA would be required to open our records for all product licences currently granted to determine which are Advanced Therapy Medicinal Products (ATMPs) and then search through these records to see which have been “reimbursed.”

Please note that, until 31 December 2020, all ATMPs would have been approved through the EMA via the centralised procedure. The EMA holds Public Assessment Reports (PARs) for all granted products through the centralised procedure, a link to the EMA website is provided below:

https://www.ema.europa.eu/en

Email: [email protected]

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review would be carried out by a senior member of the Agency who was not involved with the original decision.

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

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU

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