The European Commission is currently preparing a plan to secure the long-term supply of medicines from Britain to Northern Ireland from next year under the Northern Ireland Protocol. But despite the British government’s objections to the suggestion, Eurocrats are working on a legislative proposal to submit to the European Council and the European Parliament.
The plan would involve regulatory compliance functions, such as quality control testing for new drugs intended only for the Northern Ireland market, which would be carried out on an ongoing basis in the UK.
Rather, it would be requiring companies to put these procedures in place in Northern Ireland or the EU after existing grace periods expire in December 2021.
But Brussels said the UK government should put in place specific safeguards to ensure these products don’t go beyond Northern Ireland into the EU’s internal market.
UK ministers are also expected to fully apply EU medicines legislation on quality, safety, testing and batch release when approving products for use in Northern Ireland.
The Commission said last night that the proposed solution would be “on the basis of a clear UK commitment to put in place the guarantees”.
A Brussels source added that the legislative proposal would be submitted to Council and Parliament before the autumn.
However, if no solution is found quickly, drugmakers could withdraw up to 90 percent of the drugs they supply to the region.
In response, a source in Whitehall familiar with the ongoing negotiations around the protocol said the request for alignment with EU rules for medicines was “absurd”.
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Under the terms of the agreement, Northern Ireland will effectively remain in the EU’s single market after the end of the transition period.
EU and UK officials are currently in technical talks that include drugs in an attempt to resolve the impasse, but the UK government is keen to get a response to Lord Frost’s order document on post-trade deals. Brexit.
Lord Frost called for significant changes to the Northern Ireland Protocol, part of the deal he negotiated, as he said “we cannot continue as we are”.
A British government spokesperson said there would be a delay in checks until 2022.
They added: “While these talks with the EU are ongoing, the current arrangements for unhindered access – which ensure that no process for goods is transferred from Northern Ireland to Britain – will be maintained and no changes will be introduced in 2021.
“We will keep this under review and give traders sufficient notice if anything changes.”
Express.co.uk also understands that the ongoing negotiations may also have an impact on the expiration of grace periods next month for chilled meats.
British ministers are considering another delay as the September 30 deadline for the current extension expires, risking a potential “sausage war”.
After October 1, if the EU does not agree to further extend the grace periods, shipments of chilled meats, including sausages, to Northern Ireland from elsewhere in the UK may be restricted .
The UK initially asked in June for a 12-week extension of the grace period for animal products, which includes chilled meats such as sausages, burgers and hash, which has been granted by the Commission European.
A UK government spokesperson told Express.co.uk: “There has been continued technical contact over the summer with the Commission regarding the proposals we set out in the order document. We will approach the discussions in a spirit of ambition, imagination, real flexibility and compromise.
“We underlined in July the importance of bringing security to businesses and citizens through ‘standstill’ arrangements as these discussions progress, and we welcomed the EU decision. at the end of July not to proceed to the next stage of his legal proceedings. We will notify traders in due course of any developments in this regard. “