Freedom of Information request on clarification if the Orient Gene test was approved by MHRA at any time (FOI 21/1214)
Published 26 May 2022
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FOI 21/1214
30th November 2021
Dear,
Thank you for your enquiry dated 11 November where you asked to “clarify if the Orient Gene test was approved by MHRA at any time, for any context?”
I am pleased to provide you the following information.
The Orient Gene Rapid Antigen Test was given exceptional use authorisation by the MHRA on the 28/05/2021 as part of the Department of Health and Social Care planned deployment of COVID-19 tests in the UK. The exceptional use authorisation will run until 31/01/2022. A list of the current active exceptional use authorisations can be found here: List of medical devices given exceptional use authorisations - GOV.UK (www.gov.uk).
I hope you find this information useful.
If you have a query about this, 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