Freedom of Information request on any clinical study reports regarding the most commonly used product with amitriptyline (FOI 21-658)
Published 13 August 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: psi@nationalarchives.gov.uk.
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-21-june-2021/freedom-of-information-request-on-any-clinical-study-reports-regarding-the-most-commonly-used-product-with-amitriptyline-foi-21-658
22nd June 2021 FOI 21/667
Dear
Thank you for your email, dated 31 May 2021, in which in refining your previous request FOI 21/407, you have requested ‘any clinical study reports regarding the most commonly used product with amitriptyline.’
As you has not specified the amitriptyline product by product licence number in your request, we consider that this information is exempt under Section 12 of the Freedom of Information Act since, unfortunately, it would take us more than 24 working hours to locate, retrieve and extract the information. Section 12 of the Act allows public authorities to refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information.
As specified in our previous response, please narrow your request, for example, by restricting your FOI request to one specific product licence for which you would like the clinical study reports. Please note that substantially similar requests made within 60 working days of an original request can be aggregated into one for the purposes of calculating a cost limit, meaning that Section 12 could still apply.
Additionally, please note that your request might cover information that is 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 materials until further notice.
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 21/658.
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