FOI release

Freedom of Information request for a redacted version of the final inspection report for the GCP inspection: INSP GCP 41062/5808009-0002 (FOI-21-137)

Published 28 April 2021

Thank you for your communication to the MHRA in relation to a Freedom of Information request for a redacted version of the final inspection report for the GCP inspection: INSP GCP 41062/5808009-0002.

We would like to inform you that we are unable to supply the information you have requested. The information is exempt under Section 21 of the Freedom of Information Act (FOIA), because the information is accessible to you by another route.

• Section 21 – Information accessible by other means.

We have considered the balance of the public interest when applying this exemption. The exemption is to safeguard the commercially sensitive information / industrial secrets of a third party / commercial enterprise (which can include a Government Department). This exemption is conditional on the public interest in releasing it not outweighing the company’s/commercial enterprise’s right to confidentiality and the probable damage that the company/commercial enterprise could suffer as a result of the information being released. In this case I have not identified any issues which would benefit the public as a whole by being brought to their attention (examples of issues would be a major public health risk or a major procedural failure or irregularity).

If you have a query about this letter, please do not hesitate to contact us at IE&SFOI@mhra.gov.uk

If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please email: 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.

After that, if you remain dissatisfied, you may write to the Information Commissioner at;

The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

They will make a decision on whether or not we have interpreted the FOIA correctly in handling your request.

Yours sincerely

IE&S FOI Team