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UK Outlines Upcoming Application Rules For Generics

Standards Will Switch On 1 January 2025

 
• By Chloe Kent

New legislation that will come into effect at the beginning of 2025 will change the originator products that UK generics manufacturers must refer to when applying to bring certain products to market.

Hand drawing a red line between the UK and Northern Ireland
Currently, drugs that fall within the scope of the EU's centralized procedure require European Commission authorization in Northern Ireland • Source: Shutterstock

The UK government has published guidance outlining the implementation of changes to the licensing of medicines in the country, including generics, following the agreement of the Windsor Framework which will be implemented from 1 January 2025. The new product approval rules are needed to overcome post-Brexit complications relating to the movement of medicines between Great Britain and Northern Ireland.

The framework will allow the UK Medicines and Healthcare products Regulatory Agency to license drugs that currently fall within the...

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