Freedom of Information request on the clinical overview regarding Metformin Hydrochloride 500 mg Powder for Oral Solution (FOI 22/696)
Published 27 March 2023
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FOI 22/696
9th June 2022
Dear
Request for Clinical Overview - Metformin Hydrochloride 500 mg Powder for Oral Solution
Thank you for your email, dated 11 May 2022, in which you requested the clinical overview for Metformin Hydrochloride 500 mg Powder for Oral Solution (PL 20117/0319).
In response to your request, please find attached the clinical overview submitted to support the initial applications for Metformin Hydrochloride 500 mg and 1000 mg Powder for Oral Solution (PL 20117/0319-0320). The documentation has been redacted under Section 40 (Personal Information), Section 41 (Information given in confidence) and Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act.
Disclosure of information subject to Section 40 (Personal information) would be an infringement of personal data. Section 40 (Personal information) is an absolute exemption and no consideration of the public interest is required.
Section 41 (Information given in confidence) is an absolute exemption, and no consideration of the public interest is necessary, except to state that the release of this information withheld under this section of the FOI Act would be considered an actionable breach by the MHRA.
We have redacted some parts of the attached documentation under Section 43 (Commercial Interests) of the FOI Act because the release of all, or part of, the information would, or would be likely to, cause harm to the third party’s commercial interests. The exemption is to safeguard the commercially sensitive information/commercial enterprise. 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. We have considered the balance of the public interest when applying this exemption. In this case, we have not identified any issues which would benefit the public, as a whole, by being brought to their attention.
Please note that the documentation is historical and variation applications may have been submitted subsequently to update some of the information included.
We now consider this FOI request closed. If you have a query about this letter, please contact the MHRA FOI Licensing mailbox using the email address listed below.
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 2 months of the date you receive this response and addressed to: info@mhra.gov.uk, quoting reference FOI 22/696.
If you are not content with the outcome of the internal review, you have the right to apply directly to the Information Commissioner for a decision. The Information Commissioner can be contacted at:
Information Commissioner’s Office,
Wycliffe House,
Water Lane,
Wilmslow
Cheshire,
SK9 5AF.
Yours sincerely,
The FOI Licensing Team