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Navigating The UK's Post-Brexit Regulatory Complexities

UK Regulator Provides Clarity On Some Of The Complex Issues Involved

 
• By Ian Schofield

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.

EU stars with UK inside
EU medicines regulations still apply in Northern Ireland • Source: Alamy

Northern Ireland is a small market for medicines, but it has been at the epicenter of some major regulatory upheavals caused by the UK’s decision to leave the EU.

The location of batch testing sites and qualified persons (QPs), the requirements for importing investigational medicines to Northern Ireland, and how companies should deal with products carrying safety features required...

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