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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The European Commission’s legislative proposal will close the gaps in medicines regulation caused by Brexit and the Northern Ireland Protocol.
The European Medicines Agency says that the current shortage of antibiotics containing amoxicillin is not a “major event” and that efforts by EU and national regulators are helping to mitigate the situation.
From next year, more agencies will be involved in the UK’s regulatory reliance procedure for new drug approvals, which was first introduced in 2021 to allay fears of post-Brexit delays to UK applications. The pharmaceutical industry said it looked forward to working with the regulator on the new framework.