FOI release
MHRA Register of Active Substance Importers, Manufacturers and Distributors - Structured and Histori
This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.
Case reference FOI2026/00938
Received 21 August 2026
Published 7 October 2026
Request
Under the Freedom of Information Act 2000 I request the following information held in connection with the register of persons registered to import, manufacture or distribute active substances under regulation 45N of the Human Medicines Regulations 2012 (the register published at cms.mhra.gov.uk/mhra/api-reg). 1. A structured extract (CSV or Excel) of the current register, listing for each registration: registration number, registrant name, activity type (importation, manufacture, distribution), active substance name and code, and for importation entries the name and country of each third-country manufacturer and third-country distributor, as published on the public record pages. 2. For importation entries, a summary table of the number of registered importers and the number of distinct declared third-country manufacturers per active substance, broken down by country of the third-country manufacturer. 3. The number of active substance registrations (by activity type) on the register at 31 December in each year from 2019 to 2025. 4. A list of the third countries for which the MHRA currently accepts "written confirmation" of GMP equivalence for imported active substances, and any country-level waivers in force. All of this information is already in the public domain record by record; I am asking for it in aggregated, machine-readable form. If the full extract would exceed the cost limit, please provide items 2 to 4 first and tell me how item 1 could be narrowed to bring it within the limit.
Response
See attached
Documents
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