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For more than two years there has been real fear and concern about whether Northern Ireland will still be able to get 80% of the medicines it relies on for supply from the UK, such as certain statins and Parkinson’s drugs.
A post-Brexit agreement between the UK and the EU, known as the Northern Ireland Protocol, meant that Northern Ireland was still within the EU pharmaceutical regulatory system. The EU acknowledged that this created a practical problem and changed some laws to ease the situation, but the problem remained.
Since the beginning of 2021, of the 597 products approved in the UK by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), only eight have been approved by the same name and company in Northern Ireland. Nuffield Trust Report Found in January of this year.
The number of products currently available in Scotland, England and Wales but not Northern Ireland, such as generic versions of the Parkinson’s drug ropinirole and the statin rosuvastatin calcium, “could reach triple figures.” high,” the report said. .
new thanks Windsor Frameworknearly all concerns about drug supplies from GB to NI have been resolved, and medical experts say the deal has exceeded expectations in resolving potential long-term problems.
Medicines will cross the ‘green lane’ from the UK to Northern Ireland under a landmark deal announced by the UK and EU on Monday. The deal effectively revives the single UK market for medicines.
“This is very important and has exceeded my expectations,” said Mark Dayan, Brexit program leader at The Nuffield Trust. I“To a large extent, it means Northern Ireland returning from being a single market for pharmaceuticals to the UK market.
“There was indeed a problem of unapproved drugs in Northern Ireland, but it was in the very early stages. could have been.”
Mr Dayan said the Windsor Framework, if accepted, would “resolve almost all concerns” along with previous EU actions.
he said: The confusion of delayed requirements and the idea of pharmacists dealing with multiple regulatory systems is no longer necessary.
“The downside is that Northern Ireland will no longer have access to medicines approved by the European Union. We have seen evidence that new product approvals tend to be delayed: it is available in the Republic of Ireland, but not in Northern Ireland.”
last week, The House of Lords committee heard The “single biggest factor” causing continued supply difficulties is the application of the EU Counterfeit Medicines Directive (FMD) to Northern Ireland, not the UK. Industry representatives highlighted issues such as the extra work to ensure FMD compliance and the shortcomings of the proposed “dual regulatory regime.”
FMD is a set of regulations to protect people from counterfeit medicines in the EU. This includes additional tamper-proof security for packaging and tracking of medications using unique identifiers such as barcodes. According to the Windsor Framework, FMD provisions will no longer apply in Northern Ireland, removing bureaucratic barriers slowing the shipment of medicines from the UK.
The British Pharmaceutical Industry Association said the agreement would provide “the permanent solution our members have been looking for”.
CEO Richard Torbet said: Possible.
“It is great news that work can begin on the UK’s link to Horizon Europe, alongside measures specific to healthcare regulation. It helps.”