FOI release

Manufacturer's "Specials" Licence held by Rokshaw Limited

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 FOI2026/00909

Received 14 August 2026

Published 1 October 2026

Request

I am requesting recorded information under the Freedom of Information Act 2000. I note that in FOI2024/00264 the MHRA confirmed that Manufacturer's "Specials" Licences are not published online, and disclosed a copy of an MS licence redacted for personal data under section 40(2) and limited commercially sensitive material under section 43(2). This request follows the approach taken in that response. 1. Please provide a copy of the current Manufacturer's "Specials" Licence (all sections, including Section 1, the Section 2 variation history, and Section 3/Annex 1 site information including the authorised-operations and dosage-form schedules and any Part 2 importation authorisations) held by Rokshaw Limited of Sunderland, redacted as necessary in line with the approach taken in FOI2024/00264. 2. Please confirm the date on which the licence, or any predecessor licence subsequently subject to a change of ownership, was first granted. We are not requesting personal data, batch or product-specific information, customer information, or any commercial terms. The dosage-form authorisation schedule of an MS licence is structural information of the same character already disclosed in FOI2024/00264, in which the MHRA identified no commercial harm arising from its release.

Response

See attached

Documents

• FOI2026_00909 (redacted).pdf (1.1 MB)
• MergedLicenceDocument Rokshaw Limited 2025 (redacted).pdf (3.0 MB)

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