Brexit: EU defines possible Solutions for Northern Ireland

Recommendation

13/14 June 2023
Vienna, Austria

GMP and Quality Requirements for Radiopharmaceuticals

The European Commission has published a so-called "balanced package" of measures to address some of the most pressing issues related to the implementation of the Protocol on Ireland and Northern Ireland. With this commitment, the EU tries to find "creative solutions".

This Protocol on Ireland and Northern Ireland does not only cover medicines but also for example chilled meet (for which the grace period now was extended), guide dogs or motor insurance Green Cards. For medicines, the solution involves the "EU changing its own rules so that regulatory compliance functions for medicines authorised by the UK for the Northern Ireland market, in accordance with the Protocol, may be located in Great Britain, subject to specific conditions ensuring that the medicines concerned are not further distributed in the EU Internal Market. The Commission will put forward a legislative proposal in the early autumn to be able to finish the legislative process on time."

Source: European Commission Press Release