FOI release

CTA 56887/0001/001

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00716

Received 3 July 2026

Published 17 September 2026

Request

I am writing to request information under the Freedom of Information Act 2000. Previously, I requested information via FOI2026/00625, but was told my request was not specific enough and would not fall within the costs limit. I would like to make a revised request relating to CTA 56887/0001/001. * All formal submissions to the MHRA relating to safety and any MHRA response for the clinical trial CTA 56887/0001/001. * Final copies of the clinical trial documents (e.g. protocol, Investigator's Brochure) for the clinical trial CTA 56887/0001/001. I appreciate the cost limit is in place, but if both these aspects exceed the limit, could I please have as much relevant documentation as would be possible within the £600 limit.

Response

See attached

Documents

• 3.1 Protocol Global Amendment-clean 20250328T140219 GMT (redacted).pdf (32.2 MB)
• Bottle_Label_UK_USA-AT Approval 04OCT2022 (redacted).pdf (181.8 KB)
• FOI2026_00716 (redacted).pdf (1.3 MB)
• GMP Certificate (redacted).pdf (422.5 KB)
• GMP statements (redacted).pdf (518.8 KB)
• QP Declaration (redacted).pdf (763.8 KB)

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