FOI release

Freedom of Information request about authorisation of COVID-19 tests (FOI 21/238)

Published 7 May 2021

Thank you for your information request, dated 8 March where you asked for:

A copy of the authorisation for emergency use of the “RT-PCR test” issued by MHRA for the diagnosis of SARS-CoV-2 virus and variants

A copy of the authorisation for emergency use of the “Lateral Flow test” issued by MHRA for the diagnosis of SARS-CoV-2 virus and variants

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, below is a link to the list of all exceptional use authorisations issued by MHRA, which includes any devices associated with COVID-19 testing.

https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic/list-of-medical-devices-given-exceptional-use-authorisations  

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 will 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

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

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000