Freedom of Information request (FOI 22/1105)
Published 17 January 2024
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FOI 22/1115
12th December 2022
Dear
Paracetamol 500 mg Tablets - PL 28278/0015
Thank you for your email, dated 14 November 2022, in which you requested the following information concerning Paracetamol 500 mg Tablets (PL 28278/0015) authorised to Ipca Laboratories UK Limited:
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biowaiver
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clinical overview
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non-clinical overview.
In response to your request, we are providing the non-clinical and clinical overviews submitted for the initial application for Paracetamol 500 mg Tablets (PL 28278/0015). The documentation has been redacted under Section 41 (Information given in confidence) and Section 43 (Commercial interests) of the Freedom of Information (FOI) Act.
Please note that:
(1) Information concerning the biowaiver for Paracetamol 500 mg Tablets (PL 28278/0015) is included on page 3 of both the non-clinical and clinical overviews.
(2) As the documents were written some four years ago, some of the information contained within the documents may no longer be in line with the current state of the licence.
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.
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: [email protected], quoting reference FOI 22/1115.
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, and Cheshire, SK9 5AF.
Yours sincerely,
The FOI Licensing Team