FOI release

Freedom of Information request on Lamisil 1% Spray – Information and Clinical Studies (FOI 21-051)

Published 24 March 2021

© Crown copyright 2021

This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: [email protected].

Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.

This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-8-february-2021/freedom-of-information-request-on-lamisil-1-spray-information-and-clinical-studies-foi-21-051

Thank you for your communication, dated 8th January 2021, in which you requested the following information relating to Lamisil 1% Spray (PL 00101/0410):

  1. Information on Clinical studies
Study number(s) Volume number
SFF 301 9
SFF 351 10
SFF 309 11
SFF 104, 105 and 108 12
SFF 303 13

  1. Appendices associated with the Clinical Overview

  2. The reference Jones TC Lamisil: Expert report on clinical documentation. Sandoz R&D doc. No 701-375 Sept 1989

Please find attached appendix 1 and appendix 2 that are associated with the clinical overview. These appendices also contain some information on the requested clinical studies. Please note that Confidential information has been redacted in these documents according to Section 40 (Personal information) of the FOI Act. Section 40 is an absolute exemption and no consideration of the public interest is required.

Despite a thorough search of our electronic records, we have been unable to locate the full clinical study reports or the reference that you have requested. These documents may be held in our paper archives, which are stored externally. Given the ongoing COVID-19 outbreak, Agency staff are working remotely and are unable to access these paper records until further notice.

We apologise for any inconvenience caused. We have logged your request and will start processing it as soon as we have access to our archives again. Unfortunately, we are not able to confirm when that will be at the moment.

I now consider this request closed. If you require any further information, please respond to the FOI Licensing Team at [email protected].

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: [email protected].

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:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely,

The FOI Licensing Team

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