Europe – New agreement places Northern Ireland regulation back in the UK

Regulation of human medicines in Northern Ireland now are the responsibility of the UK Medicines and Healthcare products Regulatory Agency (MRHA) under an changes to the Brexit agreement finalized by the UK and the EU.

Northern Ireland occupied a unique position under original Brexit agreement. While the region remained part of the UK, the European Medicines Agency (EMA) became responsible for human medicines, creating a situation in which a medicine was available in England, Scotland and Wales but not in Northern Ireland. The end of the grace period in 2024 threatened to disrupt the supply of medicines to Northern Ireland, which sources 80% of its drugs from the rest of the UK…