Freedom of Information request on the clinical and non-clinical overviews for Mexiletine hydrochloride 50, 100 and 200 mg Hard Capsules (PL 31644/0027-0029, CoA from PL 39936/0011-0013)- (FOI 21-1090)
Published 26 May 2022
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FOI 21/1090
8th November 2021
Dear,
Thank you for your email of 23 September 2021, where you requested the clinical and non-clinical overviews for Mexiletine hydrochloride 50, 100 and 200 mg Hard Capsules (PL 31644/0027-0029, CoA from PL 39936/0011-0013).
Please find 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.
Please note that Section 41 of the FOI Act 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.
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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
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