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.
Last year, an EU legislative amendment addressed some problems, notably relating to generic medicines, but stakeholders continued to push the European Commission and the UK for a better system.
“The UK’s regulator will approve all drugs for the whole UK market, including Northern Ireland, with no role for the European Medicines Agency,” UK Prime Minister Rishi Sunak said in a statement. “That fully protects the supply of medicines from Great Britain into Northern Ireland, and once again asserts the primacy of UK regulation. The same medicines, in the same packs, with the same labels, will be available in every pharmacy and hospital in the United Kingdom.”
Now, application of the entire Falsified Medicines Directive will stop in Northern Ireland. The UK framed the change as “ending the unnecessary situation in which … wholesalers and pharmacies” needed “to keep barcode scanners to check individual labels.” The Commission framed the change differently, noting that the lack of EU safety features on products sold in Northern Ireland will stop the illegal circulation of medicines because they will be easily distinguishable from EU products.
Manufacturers in Northern Ireland will retain frictionless access to the EU market, according to the UK government, but steps are in place to stop human medicines intended for sale in the UK from crossing the border. Individual packs of medicines sold in Northern Ireland will carry a UK-only label and the UK “should continuously monitor their placing on the Northern Ireland market,” the Commission said. If the UK fails to meet its obligations, the Commission can unilaterally suspend the new rules.
Richard Torbett, chief executive at UK pharma trade group the ABPI, offered a cautious welcome to the deal, saying that “while we wait to see all the details, today’s agreement appears to bring a return to a single UK market for medicines, providing the permanent solution that our members have been calling for.” Torbett added that the industry will need “the right amount of time” to transition to the new rules.
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