Freedom of Information request for a copy of correspondence between MHRA and Biotec SRL (manufacturer).
Published 26 May 2022
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FOI 21/1193
30th November 2021
Dear
Thank you for your freedom of information request, dated 4 November 2021, where you (UKRP – Surgical Methods Ltd) asked for a copy of correspondence between MHRA and Biotec SRL (manufacturer).
It is the non-UK manufacturer’s responsibility to appoint a UKRP in order to comply with the UK regulations and enable them to put their devices on the UK market. Unfortunately, the disputes between the manufacturer and their UKRP are outside the MHRA’s remit.
The information that you requested is exempt from release under Section 41 – Information provided in confidence: information provided to us in confidence, with the expectation that it will not be released, is exempt from disclosure under the Freedom of Information Act 2000 (FOI Act). Information will be covered by Section 41 if: it was obtained by the authority from any other person; its disclosure would constitute a breach of confidence; a person or organisation could bring a court action for that breach of confidence; and that court action would be likely to succeed. Section 41 is an absolute exemption from disclosure and there is no public interest test to apply.
If you disagree with how we have interpreted the FOI Act 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.
Please be aware that a separate response will be sent to address your complaint.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre