Industry Warns Of New Post-Brexit ‘Cliff Edge’ For Medicines Supply To Northern Ireland
The burden of having to produce separate product packs for Great Britain and Northern Ireland is among a number of concerns raised by industry executives at a recent hearing in the House of Lords.
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Industry representatives told a House of Lords committee about continuing Brexit-related problems such as the extra work involved in checking compliance with the EU Falsified Medicines Directive and the drawbacks of a proposed “dual regulatory regime.”
The European Commission’s legislative proposal will close the gaps in medicines regulation caused by Brexit and the Northern Ireland Protocol.
The Medicines and Healthcare products Regulatory Agency says that the fee increases to be introduced on 1 April, along with 18 new fees, are necessary for its long-term financial sustainability and its ability to provide a “responsive, innovative and efficient regulatory service.”