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And Mark Samuels, the Chief Executive of the British Generic Manufacturers Association (BGMA), has urged both the UK and the EU to work together to identify a solution which will cut through the red tape in order to ensure regular supplies to the region are able to resume. Under the terms of the Protocol – which is intended to prevent a hard border on the island of Ireland – Northern Ireland remains within the bloc’s pharmaceutical regulatory system.
Most pharmaceuticals come from Great Britain – but this process has become more difficult since January as a result of the added paperwork and bureaucracy involved.
In his statement, issued after Lord David Frost called for the EU to agree to renegotiate the arrangements, Mr Samuels said: “We welcome the Government’s attempt to find a solution to medicines supply for Northern Ireland – however the situation is dragging on too long.
“We need both sides to agree a resolution for Northern Ireland immediately.
“Over many months, we have been vocal about the need for companies to know the regulatory rules for which they need to plan.
“Without an agreement between the Government and the EU, uncertainty prevents manufacturers from planning.”
He explained: “The manufacturing, quality control and supply chain for medicines are highly complex – they cannot be reengineered overnight.
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“This situation threatens to prevent companies from supplying an identical product to Great Britain and Northern Ireland.
“The result of this duplication would be to require extra warehousing, laboratory testing and technical specialists.”
Such duplication could make supplying Northern Ireland “unviable in the longer term”, Mr Samuels admitted.
He said: “After months of asking for a stable agreement between the Government and EU, our companies have been forced to put on notice over 2,000 medicines for withdrawal from Northern Ireland.
“These steps have been taken with the utmost reluctance but our members are being forced into an impossible position.
“We need all parties to set aside the politics of Brexit and put patients first.”
The UK Government has insisted there is no immediate risk to the public.
However, a spokesman said: “It is crucial the people of Northern Ireland have the same access to the full range of medicines as other parts of the UK.
“The UK government continues to work closely with the EU, industry partners and the Northern Ireland Executive to address outstanding issues with the Northern Ireland Protocol and minimise its impact on day-to-day lives.
“We have proposed bespoke arrangements that would enable medicines to move from or through Great Britain into Northern Ireland without the need for expensive and burdensome re-testing.
“Solutions must be found urgently to address this issue and others and we await a response to our proposals from the EU in writing.”
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