FOI release

FOI request - unlicensed human medicinal products

Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.

Case reference FOI2026/00987

Received 4 September 2026

Published 9 October 2026

Request

Under the Freedom of Information Act 2000, I would like to request aggregated product-level information from the MHRA Import Notification System relating to unlicensed human medicinal products notified for import into Great Britain. Please provide data for the calendar years 2024 and 2025, together with 2026 year-to-date, containing the following fields where held: 1. Active ingredient or generic product name 2. Brand name, where recorded 3. Strength 4. Pharmaceutical form 5. Pack size 6. Source country 7. Number of import notifications for each product 8. Total number of packs or units notified for import, where recorded 9. Notification outcome, including accepted, no objection, objected to, withdrawn or any equivalent classification 10. The clinical speciality or broad therapeutic category, where recorded 11. Whether the product was imported from within the EEA or from outside the EEA 12. Whether the import arose in connection with a recognised UK supply shortage, where recorded. Please provide the information in Excel or CSV format, with one row for each product, strength, pharmaceutical form, source country and reporting period combination. I am not requesting: * patient-identifiable information; * individual prescriber information; * commercially confidential pricing information; or * any information that would compromise patient confidentiality. If the identities of importers or suppliers are considered commercially sensitive, please omit those identities and provide the remaining aggregated product-level information. If pack or unit quantities cannot be disclosed, please provide the number of notifications for each product. If exact figures are considered sensitive, I would be grateful for volume bands, for example: * 1–10 notifications * 11–50 notifications * 51–100 notifications * More than 100 notifications. Please also let me know if an existing report, dataset or previous FOI response contains substantially equivalent information.

Response

See attached

Documents

• FOI2026_00987 (redacted).pdf (877.1 KB)

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