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Northern Ireland will see changes in the regulatory landscape following the issuance of the Windsor Framework on 27th Feb 2023 and the corresponding EU Commission proposal. An agreement, in principle, has been reached by the UK and EU. The new path forward of the Windsor Framework marks a turning point in how both the UK and the EU will work together collaboratively and constructively to ensure that the same medicines are available in Northern Ireland at the same time as they are in the rest of the United Kingdom. Whilst this is a successful result for Northern Ireland patients, this is major change for companies that have made specific provisions in their supply chains for Northern Ireland. The supply chains of companies where provisions and changes were made such as introduction of GB specific pack may be impacted as a result. However, the burden on the UK Pharma supply chain will be eased. Prime Minister Rishi Sunak walks with European Commission chief Ursula von der Leyen in Windsor on February 27, 2023 Pharma companies will need to carefully consider making changes within their processes and supply chains pending the issuance of clear guidance from the MHRA on the regulation changes resulting from the Windsor Agreement and the corresponding EU Commission proposed regulatory changes associated with medicinal products within the Northern Ireland market. Smooth access to the EU market for Northern Ireland pharmaceutical and medical technology firms has been safeguarded within the constraints of the agreement. The pragmatic dual-regulatory system protects business, patients and healthcare services, and reflects that it is an essential state function to maintain and oversee the supply of medicines within the whole United Kingdom.

The European Parliament on Thursday adopted a proposal from Brussels to ensure the continued supply of medicines from Britain to Northern Ireland - an issue that had dogged the bloc since London left it. "Great news from the @Europarl_EN today with the overwhelmingly positive vote to ensure the continued supply of medicines to Northern Ireland," tweeted Maros Sefcovic, European Commission vice president who had been leading discussions with London. "The EU is delivering on this lasting solution for Northern Ireland in record time," he added, though the EU Council must give final approval. Britain itself has yet to give formal approval on a move that would avoid potential disruption of supplies as London wants an overall accord for matters pertaining to the Northern Ireland protocol governing post-Brexit trade.

While Northern Irish business groups has welcomed the certainty a new EU-UK deal on post-Brexit trade rules for the region provided, the pharmaceutical industry too has expressed cautious optimism. In his speech on the Windsor Framework on Monday (February 28) Prime Minister Rishi Sunak said the agreement "delivers a landmark settlement on medicines". "From now on, drugs approved for use by the UK's medicines regulator will be automatically available in every pharmacy and hospital in Northern Ireland," he announced. The National Pharmacy Association's Northern Ireland manager Anne McAlister expressed a sense of cautious optimism. She said: "While the devil may yet be in the detail, the Windsor Framework would appear to be good news for pharmacies in Northern Ireland. It seems to address the main concerns we have expressed about medicines supplies to NI, but we want to examine the small print to ensure the new arrangements meet the needs of our members and the patients they serve.