The Windsor Framework for parallel importers: UK-wide licences, the 'UK Only' label, and the end of EU safety features on import packs

What changed

Between 2021 and 2024 the UK ran two medicines regimes: Great Britain under MHRA rules, Northern Ireland under EU rules, with “PLGB” and “PLNI” licences and EU safety features still required in Northern Ireland. The Windsor Framework, agreed in 2023 and applied to medicines from 1 January 2025, ended the split. The MHRA now licenses medicines for the whole United Kingdom, Northern Ireland has left the EU’s falsified-medicines verification system, and a single “UK Only” pack serves both.

For parallel importers four things follow.

Licences are UK-wide. Parallel import licences that covered Great Britain only were converted to UK-wide licences automatically, with no variation to file; new licences are numbered “PL” rather than “PLGB”. The EU Parallel Distribution Notice route, which had let EU-sourced centrally authorised products reach Northern Ireland, ceased to be valid there on 1 January 2025: a parallel import into Northern Ireland now needs a UK parallel import licence like any other.

Every pack says “UK Only”. All medicines placed on the UK market, including parallel-imported packs, must carry the words “UK Only” on the outer packaging in at least seven-point type. Stickering was allowed until 30 June 2025; from July 2025 the words must be printed. Packs released before the change may be supplied until they expire.

EU safety features no longer apply to import packs. The serialised two-dimensional code and the EU verification that the Falsified Medicines Directive requires do not apply to parallel-imported packs in the UK. Where a pack from the EEA carries a code that has been uploaded to the EU repository, the pack must be decommissioned by the supplier before export and the code removed or covered, so that the pack cannot re-enter the EU supply chain. The anti-tamper device stays.

Northern Ireland wholesalers and pharmacies stop scanning. The UK’s Northern Ireland verification system was disconnected from the EU hub at the end of 2024. EEA-livery packs bought in Northern Ireland for onward supply to the EEA may continue to move and need no decommissioning, so Northern Ireland wholesalers handle two kinds of stock.

What it means if you are…

A parallel importer. One licence, one pack, both markets: a UK parallel import licence now gives access to Northern Ireland, which the old GB-only licence did not. The costs are artwork (printed “UK Only”), the decommissioning step with every EEA supplier, and the loss of any chance of moving an imported pack back into the EEA, since a decommissioned pack is dead in the EU system. Sourcing from the EEA is otherwise unchanged, and the exhaustion decision of May 2025 confirms it stays lawful.

A generics or launch planner. A single UK licence and a single pack simplify launch logistics, and the “UK Only” rule applies to generics too. Nothing here changes patent or SPC exclusivity.

A wholesaler or buyer. Expect “UK Only” on everything, including imports, and a parallel import licence number on imported packs supplied anywhere in the UK. In Northern Ireland the EU scanning obligation has gone; stock destined for the EEA is the exception and keeps its EU features.

What to watch

The MHRA’s parallel import licence guidance was rewritten in May and September 2025 and again in August 2026 (submission process, variation codes, cover sheets), and licence fees rose about a fifth in April 2025 with a further rise proposed for April 2027. The EU side of the arrangement, Regulation (EU) 2023/1182, has not been amended since.