Industry Gets Breathing Space For Post-Brexit Regulation In Northern Ireland
One-Year Phase-In Period Addresses Pharma’s ‘Cliff Edge’ Concerns
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.
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In its latest letter to medicines and medical product companies, the UK's Department of Health and Social Care says the biggest potential cause of disruption to supplies could be failure to prepare for border controls implemented by the EU member states after the end of the Brexit transition period.
From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries.
Companies supplying into Northern Ireland now have more time to prepare for post-Brexit regulatory changes in areas like batch testing, imports and Falsified Medicines Directive requirements. UK industry association, PAGB, in a joint statement with five other pharmaceutical industry associations, including AESGP, describes it as a step in the right direction, but also warns that there is still much work to do.