MHRA Provides Details On Windsor Framework For UK Medicines

By Deborah Harrison

The Windsor Framework, a landmark agreement between the UK and EU, is set to revolutionize the supply and regulation of medicines in Northern Ireland. Effective January 1, 2025, the framework grants the Medicines and Healthcare Regulatory Agency (MHRA) sole authority over medicines licensing for the region.

This article delves into the key implications of the framework, including:

UK-wide licensing: All medicines will be licensed under UK law, ensuring seamless access for Northern Irish patients.

Packaging and labeling changes: New requirements for "UK only" labeling and adherence to UK regulations will be implemented.

Distribution and manufacturing considerations: The framework outlines new rules for storage, movement, and export of medicines.

As the implementation date approaches, industry stakeholders must adapt to these changes to ensure uninterrupted supply and compliance with regulatory standards.