One Country, Two Regulatory Systems: Another Brexit Headache

Northern Ireland’s Special Status Poses Major Challenges

The Northern Ireland Protocol brings added complexities that for medicines regulation in the UK, particularly in areas such as new drug approvals and batch release procedures.

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Brexit continues to get ever more complicated • Source: Shutterstock

Brexit was complicated enough for life science companies in terms of the future regulatory relationship between the UK and the EU. They now have to consider the added complexities of the Northern Ireland Protocol.

As things stand, when the transition period relating to the UK's departure from the EU, ends on 31 December, the...

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