EU Adopts New Rules On UK-Wide Approvals For Novel Drugs

Having been passed by the European Parliament and now the Council of the EU, new legislation will clear up some of the issues raised by Brexit relating to trade in medicines between Great Britain and Northern Ireland.

Complicated wires
A new EU regulation will untangle a knotty post-Brexit problem • Source: Shutterstock

A new regulation just adopted by the Council of the EU will give the UK Medicines and Healthcare products Regulatory Agency (MHRA) responsibility for approving innovative new medicines on a UK-wide basis, making it easier for pharmaceutical companies to market such products in Northern Ireland.

This means that eventually new centralized EU marketing authorizations will no longer be valid in Northern Ireland, as they currently are under the Northern Ireland Protocol, and that medicines approved by the MHRA will be available in Northern Ireland at the same

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