FOI release

Freedom of Information request on Canesten HC Cream (FOI 21-667)

Published 13 August 2021

23rd June 2021 FOI 21/667

Dear

Thank you for your communication, dated 14 June 2021, in which you requested the following information relating to Canesten HC Cream (PL 00010/0120):

• The phase 2 and phase 3 clinical study synopses and Module 2.5 (Clinical Overview) which supported the original MAA

Despite a thorough search of our electronic records, we have been unable to locate the documentation 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 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.

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