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Industry Gets Breathing Space For Post-Brexit Regulation In Northern Ireland

One-Year Phase-In Period Addresses Pharma’s ‘Cliff Edge’ Concerns

 
• By Ian Schofield

The pharmaceutical industry has welcomed a decision to allow more time to bring in new medicines regulations in Northern Ireland, but continues to insist that a mutual recognition agreement between the UK and the EU on drug manufacturing is the best way forward.

Belfast in the map with pin
Northern Ireland will have different drug regulations from the rest of the UK • Source: Shutterstock

The UK government and the EU have heeded calls from the pharmaceutical industry for a one-year phasing-in period for the medicine-related aspects of the Northern Ireland Protocol, giving companies more time to prepare for post-Brexit regulatory changes in areas like batch testing and imports.

Under the Northern Ireland Protocol, which was agreed by the UK and the EU as part of the Brexit Withdrawal Agreement, EU medicines regulations will continue to apply in Northern Ireland after the end of the transition period on 31 December, although those rules will be enforced by the UK regulatory

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