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.