Freedom of Information request on the assessment reports and data for Lipantil Micro 200 mg (FOI 22/061)
Published 31 May 2022
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FOI 22/061:
8th February 2022
Dear
Lipantil Micro 200 mg, capsules (PL 46302/0042)
Thank you for your email, dated 10 January 2022, in which you clarified your request FOI 21/1336, dated 24 December 2021, for assessment reports and data for Lipantil Micro 200 mg, capsules (PL 46302/0042).
A Marketing Authorisation for Lipantil Micro 200 mg, capsules (PL 46302/0042) was granted to Mylan Product Limited on 07 September 2016, following a change of ownership procedure of Lipantil Micro 200 mg, capsules (PL 43900/0045). Lipantil Micro 200 mg, capsules (PL 43900/0045) was granted to BGP Products Limited on 18 March 2015, following a change of ownership procedure of Lipantil Micro 200 mg, capsules (PL 00512/0390). A Marketing Authorisation was granted to Abbott Healthcare Products Limited for Lipantil Micro 200 mg, capsules (PL 00512/0390) on 03 July 2007, following a change of ownership procedure of the original product licence Lipantil Micro 200 mg, capsules (PL 12509/0001), which was granted to Fournier Pharmaceuticals Limited on 12 November 1993.
We have searched our records (including our archived paper records) for the MHRA non-clinical and clinical assessment reports for the initial application submitted for the original product licence for Lipantil Micro 200 mg, capsules (PL 12509/0001), however we do not appear to hold this information. Having exhausted the usual avenues in our search for this information, we conclude that, if it was ever held, it is no longer on our systems in a retrievable form.
The release of quality data (including the quality assessment report), is exempt under Section 21 (Accessible via other means), Section 40 (Personal Information), Section 41 (Information given in confidence) and Section 43 (Commercial interests) of the Freedom of Information Act.
Therefore in response to your request for data for Lipantil Micro 200 mg, capsules (PL 46302/0042), please find attached non-clinical and clinical overview addenda, which were submitted to support a number of variation applications for Lipantil Micro 200 mg, capsules received since it was first
granted. Please note that we have searched our records (including our archived paper records) and have not found the non-clinical and clinical overviews provided to support the initial application for the original product, Lipantil Micro 200 mg, capsules (PL 12509/0001). Having exhausted the usual avenues in our search for this information we conclude that, if these were ever held, they are no longer on our systems in a retrievable form.
The documentation has been redacted under Section 40 (Personal Information), Section 41 (Information given in confidence) and Section 43 (Commercial Interests) of the Freedom of Information (FOI) Act.
Disclosure of information subject to Section 40 (Personal information) would be an infringement of personal data. Section 40 (Personal information) is an absolute exemption and no consideration of the public interest is required.
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.
Please note that the documentation is historical and variation applications may have been submitted subsequently to update some of the information included.
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: info@mhra.gov.uk, quoting reference FOI 22/061.
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