EU’s Northern Ireland Drug Supply Solution Imminent
The European Commission’s legislative proposal will close the gaps in medicines regulation caused by Brexit and the Northern Ireland Protocol.
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The UK regulator explains the new requirements for batch testing and release in Great Britain and Northern Ireland, what's involved in importing clinical trial drugs to Northern Ireland, and what factors determine the location of the Qualified Person.
The latest proposals for solving regulatory and trade issues caused by Brexit and the Northern Ireland Protocol have been welcomed by EU and UK pharmaceutical industry bodies.
Efforts to overhaul the EU pharmaceutical legislation have been given added impetus after the European Parliament called for action to boost innovation and medicines access, shore up manufacturing and supply chains, and examine the link between R&D spending and drug prices.