FOI release

Freedom of Information request (FOI 22/1044)

Published 17 January 2024

19th November 2022

FOI 22/1044

Dear

Thank you for your Freedom of information request dated 16th October 2022, where you requested the following information:

  1. FOI request: Please supply the information supplied to the MHRA by the DHSC every 2 weeks under point 10
  2. FOI Request: Was the authorisation extended past the 22 June 2021 date set by the MHRA?
  3. FOI Request: Please supply the information supplied by the DHSC to the MHRA as per point 17, the monthly Post market Surveillance plan and Quality Management System

Regarding question 2, the Exceptional Use Authorisation was extended past 22nd June 2021.

With regards to questions 1 and 3, there are commercial sensitives around this information. We have sought advice which indicated that the Section 41 exemption of the Freedom of Information Act 2000 does not apply in this case. Therefore, we have been in touch with UKHSA on your behalf, the legal manufacturer of the tests, and they have requested that you contact them with your questions.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.

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 online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/

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 Covid-19 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

Kind regards,

MHRA Customer Experience Centre