Freedom of Information request (FOI 22/992)
Published 17 January 2024
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16th November 2022
FOI 22/992
Dear
Thank you for your communication, dated 23 September 2022, in which you requested the following information:
• A copy of the non-clinical and clinical overview that was submitted for the following products:
o Melatonin 2 mg, 3 mg & 5 mg Hard Capsules (PL 41344/0058-60)
o Melatonin 3 mg film-coated tablets (PL 39936/0006)
o Melatonin 1mg/ml oral solution (PL 41344/0050)
Please find attached copies of the Clinical and Non-Clinical Overviews.
Confidential information has been redacted in these documents, according to Section 41 (Information provided in confidence) and Section 43 (Commercial interests) of the FOI Act. Section 41 is an absolute exemption and no consideration of the public interest is required. Section 43 is a conditional exemption, 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 we 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).
I now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at FOILicensing@mhra.gov.uk.
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.
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,
The FOI Licensing Team