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New Brexit deal ushers in changes to medicines regulations

Posted on the 27th February 2023

Brexit Europe

The UK Prime Minister, Rishi Sunak, and President of the European Commission, Ursula von der Leyen, have announced a new deal, aimed at fixing post-Brexit problems in Northern Ireland.

The Windsor Framework contains several proposals that, if implemented, will have implications for the regulation of medicines in Northern Ireland.

These include the removal of the European Medicines Agency (EMA) from all aspects of medicines regulation affecting Northern Ireland with the UK Medicines Regulator (MHRA) assuming full and sole control of these duties.

In addition to this, the False Medicines Directive will be disapplied to Northern Ireland. This would remove the need for NIMAR (Northern Ireland Medicines Access Route) and allay concerns some companies were having in relation to the Directive including the need for separate packaging and labelling.

Meanwhile, the Framework will safeguard frictionless access to the EU market for Northern Ireland pharmaceutical and medical technology firms.

It also establishes a foundation for an Associate Agreement to allow the UK to participate in the Horizon Research and Development Programme.

The full document can be read here

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