Freedom of Information request on Ethigen Inspection reports 2017 (FOI 21/003)
Published 24 March 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-1-february-2021/freedom-of-information-request-on-ethigen-inspection-reports-2017-foi-21003
As requested under the Freedom of Information Act, please find enclosed Ethigen Ltd reports from 2017.
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) .
We would like to inform you that we are not able to provide you with the most recent inspection reports for the company, details regarding investigation made by MHRA and Whistleblowing/Complaints by current/previous members of staff and/or customers/members of public and the outcomes as they are exempted under Section 30:
Section 30 – Investigations: the information you have requested concerns an active Agency investigation and it is therefore exempt under section 30 of the FOI Act, which concerns investigations and proceedings conducted by public authorities. Section 30 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.
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
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