2 weeks Ago By David Thompson
Did you know with an ad-lite subscription to NorthernIrelandWorld, you get 70% fewer ads while viewing the news that matters to you. Under the original Northern Ireland protocol, medicines entering Northern Ireland would have had to meet EU specifications rather than UK ones, leaving big question marks over how the NHS would operate on a UK -wide basis. The party’s Dr Dan Boucher, who advises Jim Allister in Westminster, has told the News Letter: “Concerns remain particularly in relation to category 2 medicines both because they remain subject to certain EU regulations and because of the complexity arising from needing to provide medicines subject to category 1 and category 2 requirements”.
Advertisement Advertisement The new rules came into effect on January 1. Medicines will fall into two categories. The first encompasses medicines that were previously within the mandatory or voluntary scope of the EU’s ‘centralized authorization procedure’.
They will now be licensed in the UK, and regulated by the MHRA and subject to UK law. However, the second category covers drugs which don’t meet the criteria for Category 1, and will remain subject to certain EU legal requirements. These include aspects of pharmacovigilance such as the submission of Periodic Safety Update Reports (PSURs), Post Authorization Safety Studies (PASS) and Safety Referrals.
Advertisement Advertisement Last year, the Association of the British Pharmaceutical Industry (APBI) expressed concerns about the new rules. “Where companies have large and diverse portfolios, a two-category system might create a complex landscape as different products may be subject to different regulations”, they said. “Additionally, it is currently unclear what future divergence between UK and EU regulations will look like, and whether this will add even further complexity.
Both the MHRA and the Department of Health and Social Care (DHSC) have stated that mechanisms will shortly be introduced that provide a forum for the UK and EU to discuss any issues of divergence in regulations”. National World encourages reader discussion on our stories. User feedback, insights and back-and-forth exchanges add a rich layer of context to reporting.
Please review our Community Guidelines before commenting. Did you know with an ad-lite subscription to NorthernIrelandWorld, you get 70% fewer ads while viewing the news that matters to you..
