FOI release

Freedom of Information request on all closed GCP and PV inspections conducted between 1st of January 2018 - 30th of April 2021 (FOI 21/1162)

Published 26 May 2022

24th November 2021

FOI 21/1162

Dear,

Thank you for your communication to the MHRA in relation to a Freedom of Information request for PV and GCP inspections conducted between 1st of January 2018 - 30th of April 2021 which resulted in major or critical findings.

Please find attached the lists of all closed GCP and PV inspections conducted between 1st of January 2018 - 30th of April 2021.

You will see that some information has been redacted. The relevant sections of the Freedom of Information Act are marked at the side of each redaction. These are:

• Section 40 – This information contains elements of personal data, the disclosure of which would be unfair in that it would breach the first principle of the Data Protection Act which says that information must be processed fairly and lawfully.
• Section 43 – Release of all, or part of, the information would, or would be likely to, cause harm to the third party’s commercial interests.

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) .

Some of the requested GCP inspection reports are exempted under Section 31.

• Section 31 – Law enforcement: the information you have requested is being withheld under section 31 of the FOI Act, which applies to the release of information that may prejudice the prevention or detection of crime. Section 31 is a qualified exemption, which means that we have considered whether the public interest in releasing the information is outweighed by the public interest in not giving the information.

Furthermore, we would like advise you that we are unable to provide you with the requested reports as we have determined that the information is exempt under Section 12 of the Freedom of Information Act and we cannot process your request any further.

• Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.

If you still wish to obtain copies of some of the reports, please would you narrow your scope of the request to bring it within the 24 hour limit – for reference it is possible to provide approximately 20 of the reports requested within 24 hours. You may wish to refine your request to be specific, for example, the 20 most recent inspection reports from last year or the 20 most recent inspection reports with critical or major findings, based on your interest. We are only able to provide copies of reports for closed inspections. Please note that once we receive a reply we will treat this as a new FOI request and the 20 working day response time will re-commence.

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

MHRA

Inspection, Enforcement and Standards