Freedom of Information request (FOI 22/1001)
Published 17 January 2024
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25th October 2022
FOI 22/1001
Dear
Thank you for your email, dated 27 September 2022, in which you requested the Protocol and Clinical Study Report (CSR) associated with NCT03150589 (SB11-G31-AMD) for Byooviz’.
We are refusing your request for this information under Section 21 (Information accessible by other means) of the Freedom of Information Act, as the requested documentation is available on the official website of the Government of Canada. Please find the electronic link to access the requested documentation below:
Search for clinical information on drugs and medical devices - Canada.ca
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 22/1001.
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