Medicines and Healthcare products Regulatory Agency / GOV.UK

Advanced therapy medicinal products: regulation and licensing in UK

Regulatory · Tier 1, UK official · UK · 2015-01-26, updated 2025-03-06

Current — checked with the publisher on 2026-09-01

https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing-in-uk

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How this record was checked, and what is doubtful about it

SENTINEL YEAR RESOLVED. Published 26 January 2015, last updated 6 March 2025. Covers classification, Innovation Office, scientific advice, clinical trials, marketing authorisation (UK-wide only post-Windsor Framework), combination ATMPs, manufacturer's licences, unlicensed ATMPs including hospital exemption, and human tissue oversight.

Verification: verified · last accessed 2026-09-01 · status checked against https://www.gov.uk/guidance/advanced-therapy-medicinal-products-regulation-and-licensing-in-uk