Windsor Framework medicines provisions resolved the Northern Ireland Protocol's pharmaceutical supply burden from January 2025. MHRA is the sole regulator for all human medicines marketed in UK (GB + NI) with a single UK-wide marketing authorisation. EU centralised procedure no longer applies in NI; conversion of existing centrally-authorised products to UK-wide MAs via MHRA grandfathering through 2024-2025. New MA pathways — UK national procedure, International Recognition Procedure (IRP launched January 2024 drawing on FDA, EMA, Health Canada, TGA, Swissmedic, Singapore HSA, Japan PMDA approvals), Project Orbis oncology pathway with FDA and partners, Innovative Licensing and Access Pathway (ILAP). Single UK-wide labelling — single pack design for UK with mandatory 'UK Only' marking on outer packaging for medicines authorised solely under UK MA route (not dual-authorised in EU/EEA) to prevent diversion to EU single market; MHRA specifies font, placement, language. Falsified Medicines Directive safety features (2D DataMatrix with product code, serial number, batch, expiration, NHRN, anti-tampering device) no longer apply to UK-only-marketed medicines from Framework go-live — SecurMed UK ceased operation for UK-only products; pharmacy decommissioning stopped for UK-only. Dual UK/EU-marketed products retain FMD features on EU-marketed packs. FMD relief conditional on 'UK Only' labelling — unmarked packs presumed dual-marketed and must carry FMD features. Voluntary serialisation may continue for supply-chain visibility independent of FMD. Wholesale distribution — MHRA WDA(H) covers UK-wide; NI wholesalers no longer need separate EU wholesale authorisation for centrally-authorised products; parallel-import licences via MHRA UK-wide; EU-route parallel-import for NI ceased. Pharmacy practice remains devolved (Scotland, Wales, NI distinct frameworks). GMP/GDP inspection unchanged — MHRA inspectorate UK-wide; MIA, MIA(IMP), WDA(H) licences continue. Veterinary medicines covered by separate Windsor Framework arrangement with implementation through 2025-2026.

Regulatory anchors

Human Medicines (Amendment etc.) (Windsor Framework) Regulations 2024
Council Regulation (EU) 2023/1182
Human Medicines Regulations 2012

Industries that live with this

Pharmaceutical Vet Pharma Radiopharma

How V5 handles it

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

Labels — designed, approved, printed and audited in one place.

Most regulated manufacturers run a label tool (NiceLabel, Loftware, BarTender) bolted next to their QMS — versions drift, reprints aren't audited, and 211.122 / 111.130 / 820.120 findings follow. V5 puts the designer, the approval workflow, the print agent and the reprint audit trail in one place — the same place that holds the BMR.

Lot traceability — recall in minutes, not weeks.

V5 captures the lot link at every point of consumption, so the trace is a query — not a war room.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Related terms

UK Clinical Trials Regulations 2024