Freedom of Information request (FOI 22/1017)
Published 17 January 2024
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31st October 2022
FOI 22/1017
Dear
Thank you for your email.
Regarding your request for information on Overviews on the Clinical & Non-Clinical of the following product Clonidine hydrochloride 50micrograms/5ml Oral Solution PL 39307/0082.
We are pleased to be able to provide these documents albeit with some redactions under Section 43(1 & 2) and Section 41 of the FOIA.
Section 41 is an absolute exemption and no consideration of the public interest is required, except to state that we consider its disclosure to constitute an actionable breach of confidence.
Section 43 is a qualified exemption and a consideration of the public interest should be made. We have considered the public interest and cannot see any public interest argument that outweighs the commercial harm in alerting competitors to proprietary information that could be used to accelerate the development of a competitor product. Examples of public interest arguments would be a major public health risk or a major procedural failure or irregularity.
Please note due to file size this message has been divided in two, a second email with the clinical overview should follow shortly.
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Yours sincerely
Health Quality and Access FOI Team