Freedom of Information request about MHRA's exceptional use authorisation for NHS Test and Trace COVID-19 Self-Test device (FOI 21/297)
Published 7 May 2021
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Thank you for your information request, dated 18 February and 19 March where you asked for:
The full text of MHRA’s exceptional use authorisation for NHS Test and Trace COVID-19 Self-Test device.
Unfortunately we cannot share information that is specific to named manufacturers. This includes makes and models that would identify the manufacturer.
The information you have asked for is exempt from disclosure under Section 44 of the Freedom of Information Act 2000 (FOIA).
Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.
The MHRA is satisfied that the information you have requested:
constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.
relates to the affairs of businesses which continue to exist.
On that basis we are satisfied that section 44 of FOI Act apply, and the information is exempt from release.
However, you may find more information about the exceptional use authorisation for NHS Test and Trace COVID-19 Self-Test device here:
MHRA issues exceptional use authorisation for NHS Test and Trace COVID-19 Self-Test device - GOV.UK (www.gov.uk)
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/
or by post:
Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire
SK9 5AF
Kind Regards
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000