Windsor Framework Explainer Document published

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published an "Explainer for Industry" on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland. The document wants to serve as both an educational tool and an action guide, ensuring stakeholders are prepared for the regulatory transition under the Windsor Framework.

The Windsor Framework, established on February 27, 2023, is a UK-EU agreement replacing the original Northern Ireland Protocol. It ensures consistent medicine supply across the UK by implementing UK-wide licensing and removing EU licensing processes in Northern Ireland for novel medicines. New rules were published in September by MHRA and will be effective from January 1, 2025: The idea is that these simplify processes, eliminate separate labelling and packaging requirements, and repeal the EU Falsified Medicines Directive (FMD) in Northern Ireland.

The intention of this "Explainer" document is to provide a clear and detailed overview of the regulatory changes introduced under the Windsor Framework regarding the supply of human medicines in Northern Ireland. It should be read in conjunction with the other MHRA guidance on the Windsor Framework, including the UK-wide licensing guidance and labelling and packaging guidance. It aims to:

• Inform Stakeholders: Ensure that all relevant parties, including manufacturers, wholesalers, regulators, and healthcare providers, understand the new arrangements.
• Clarify Changes: Highlight the key regulatory shifts, such as the move to UK-wide licensing, disapplication of the EU Falsified Medicines Directive in Northern Ireland, and updated labelling requirements.
• Facilitate Compliance: Provide guidance on actions stakeholders need to take (e.g., updating licences, packaging, and pharmacovigilance procedures) to comply with the new rules effective from January 1, 2025.
• Promote Consistency: Emphasize the benefits of a unified UK-wide regulatory framework, ensuring the same medicines are available across the UK in consistent packaging and under the same regulatory conditions.
• Mitigate Disruption: Address potential challenges in transitioning from EU regulations, particularly in Northern Ireland, to avoid supply chain disruptions and ensure patient safety.