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Brief
Here is the summary within the 90-word limit: This guidance applies until January 1, 2025. After this date, the Windsor Framework will take effect. Under the new framework, novel medicines for Northern Ireland will be assessed and licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) on a UK-wide basis. The European Medicines Agency (EMA) is no longer involved in the process for these products. This change applies to all products within the scope of the EU's Centralised Procedure, ensuring consistent regulation across the UK.
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