Guidance

Centrally Authorised Products (CAPs) Bridging Mechanism

Guidance on measures in place until the Windsor Framework takes effect on 1 January 2025.

From:
Medicines and Healthcare products Regulatory Agency
Published
9 June 2023

Documents

Centrally Authorised Products (CAPs) Bridging Mechanism

HTML

CAP Bridging Mechanism Flowchart

PDF, 577 KB, 2 pages

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Details

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 EU’s Centralised Procedure on a UK-wide basis.

Published 9 June 2023