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EU HUB | What is the legal basis for the exit of UKNI from the EMVS?
EU HUB | What is the legal basis for the exit of UKNI from the EMVS?
Written by Jessica Clifford
Updated over a week ago

The Protocol on Ireland/Northern Ireland, known as the Windsor Framework, is part of the agreement that set out how the United Kingdom would leave the European Union. This agreement became effective on February 1, 2020. The Northern Ireland Protocol (NIP) stated that EU pharmaceutical laws would apply to Northern Ireland only, starting from January 1, 2021. However, this will change when the Windsor Framework comes into effect to alter the terms of the NIP. The Windsor Framework established long-term plans for supplying medicines to Northern Ireland. It ensures that medicines can be approved and licensed across the UK by the Medicines and Healthcare products Regulatory Agency (MHRA), following UK rules and authorization procedures only. Additionally, the Windsor Framework mandates in Article 36 that EU Falsified Medicines Directive (FMD) requirements won't apply to medicines sold in Northern Ireland. Ultimately, the FMD rules will no longer apply in Northern Ireland once the provisions set by Regulation (EU) 2023/1182 are applied, as outlined in Article 14 of that Regulation.

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