What MAHs Need to Know in 2025

The Windsor Framework, which came into effect on January 1, 2025, brings significant regulatory transformations to pharmacovigilance (PV) practices throughout the United Kingdom. In this new landscape, Great Britain (GB) adheres to the established UK PV legislation, while Northern Ireland (NI) remains committed to the European Union’s Good Vigilance Practices (GVP) standards for Category 2 products.

This divergence necessitates that Marketing Authorisation Holders (MAHs) navigate two distinct regulatory environments, requiring them to implement and refine their processes to ensure compliance with both sets of regulations. As a result, MAHs must invest in robust systems and training to effectively manage the complexities of dual compliance, thereby safeguarding public health while maintaining the integrity of their operations in both regions.

Key Changes:

• Removes EU licensing processes in relation to Northern Ireland for novel medicines (those that were authorised under the EU Centralised Procedure) – medicines authorisations granted by the EC will no longer be valid in Northern Ireland
• Removes any requirement for EU Falsified Medicines Directive (FMD) packaging, labelling and serialisation barcode for medicines in Northern Ireland
• Requires all medicines placed on the UK market to be labelled ‘UK Only’, indicating they are not for sale in the Republic of Ireland or other EU countries
• Licences will be UK wide; Companies will no longer need to apply for separate licenses for Great Britain and Northern Ireland