Guidance: Centrally Authorised Products (CAPs) Bridging Mechanism

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Medicines Healthcare Products Regulatory Agency

June 9

11:00 2023

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Centrally Authorised Products (CAPs) Bridging Mechanism

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CAP Bridging Mechanism Flowchart

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This guidance applies until such time as the Windsor Framework takes effect on 1 January 2025. Under the Windsor Framework, rather than novel medicines for use in Northern Ireland requiring an application to the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA) will assess applications and license all products in the scope of the EUs Centralised Procedure on a UK-wide basis.

Published 9 June 2023

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