Freedom of Information request on a copy of the non-clinical overview/expert report and clinical overview/expert report that was submitted for Melatonin 1mg/ml oral solution (PL 41344/0050)- (FOI 21/1041)
Published 26 May 2022
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FOI 21/1041
4th November 2021
Dear,
Thank you for your communication, dated 14 June 2021, in which you requested the following information:
• A copy of the non-clinical overview/expert report and clinical overview/expert report that was submitted for 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:
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Yours sincerely,
The FOI Licensing Team