FOI release

Freedom of Information request on how Avacta identified whether information is suitable or unsuitable for public disclosure by the MHRA (FOI 21-603)

Published 13 August 2021

29th June 2021 FOI 21/603

Dear

Thank you for your information request, dated June 1st, 2021, where you asked for ‘If the MHRA are not allowed to give out this information can I ask whether other companies are allowed to do so? How have Avacta identified such information if it is not suitable for public disclosure by the MHRA? Finally, if this information is not true are you able to establish this as soon as possible?’

Unfortunately, MHRA is not able to comment on what information other companies hold or are allowed to disclose. We suggest to address these questions to the company who provided you with such information.

For your final question, unfortunately, we cannot comment on the status of the registration application under section 43 of Freedom of Information Act 2000. However, you can explore which devices are already registered with MHRA via Publicly Accessible Registration Database (PARD).

If you have a query about the information provided, please reply to this email.

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 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,

Enquiries Co-ordinator

Devices Division

Medicines and Healthcare Products Regulatory Agency