Our journey began with a curiosity about how medicines reach patients, particularly in areas with complex political and regulatory environments. Northern Ireland(NI) is one such region that faced major challenges in the supply of medicine following Brexit. Though NI was part of the United Kingdom (UK), it shared a border with the Republic of Ireland, a European Union member state. Because of this situation, NI had to navigate a dual regulatory system. This meant that a single medicinal product had to comply with both MHRA (UK) and EMA (EU) requirements, which created confusion after Brexit, especially in how medicines were approved, labelled, and supplied to NI.
The Windsor Framework was announced in February 2023 to address these challenges and came into effect from 01 January 2025. This new agreement between the UK and EU aims to provide regulatory clarity and smoother access to medicines throughout the UK, including Northern Ireland.
Our recently published paper in Therapeutic Innovation & Regulatory Science (https://doi.org/10.1007/s43441-025-00753-7) provides a comparative analysis of how medicine regulations in NI have changed before and after the implementation of the Windsor Framework, focusing on areas such as licensing, QP batch release, labelling, supply routes, advertising and pharmacovigilance reporting. This review is a practical guide for stakeholders such as manufacturers, Marketing Authorisation Holders and regulatory professionals to understand the regulatory changes and their practical implications.
Need for the Windsor Framework:
- To avoid a hard border between NI and the Republic of Ireland while maintaining the integrity of the EU single market.
- To resolve dual regulatory conflicts where medicines in NI had to meet the MHRA (UK) and EMA (EU) regulations, leading to delayed approvals of new medicines and duplication of existing data.
- To address medicine shortages caused by disrupted supply chains and complex import requirements post-Brexit.
- To simplify licensing and labelling processes and reduce the administrative burden on pharmaceutical manufacturers and wholesalers operating across the UK and EU markets.
- To restore patient access and public confidence by ensuring a faster and more reliable supply of medicines throughout the UK, including NI (1)
Impact of the Windsor Framework:
The key improvements of the Windsor Framework include:
- MHRA becomes the sole authority: MHRA is now the sole regulatory authority for approving medicines across the UK (including NI). There is no longer a need to comply with overlapping EU regulations.
- Unified Licensing and Labelling: A medicinal product no longer requires two marketing authorisations (one from the MHRA and one from the EMA). Instead, a UK-wide license can be mandatorily used with a ‘UK Only’ statement on outer packs.
- Falsified Medicines Directive (FMD) features are no longer mandatory: The EU FMD, which required barcodes and other serialisation features, has been disapplied in NI and has to meet UK safety requirements.
- Simplified Customs: Green & Red Lanes: A green lane has been introduced for products moving within the UK, i.e., between Great Britain and Northern Ireland or vice versa, which are subjected to fewer checks. The red lane system is for products moving between the EU and UK (including NI) subject to stricter checks.
- Pharmacovigilance: Pharmacovigilance and safety reporting are now fully monitored by the UK’s MHRA system(2).
The Future of the Windsor Framework:
The Windsor Framework was not only introduced to streamline the process of movement of goods across NI–GB–EU, but it was also intended to reduce the political stress induced due to Brexit. The shared island of Ireland has been in a chaotic environment since 2020. However, the NI/Ireland protocol was introduced to avoid a hard border between the two countries; the failure to completely implement the protocol increased both countries' political and cultural tensions. Hence, the Windsor Framework is expected to foster a more united and peaceful relationship among the UK, NI and the EU. Looking ahead, the framework may shape NI’s role in different ways. Some foresee the possibility of a united Ireland, while others warn of the NI area becoming politically isolated if the internal tensions in the UK grow further. Alternatively, NI may continue to hold a special status, benefiting from links to the UK and EU. Though challenges remain, the framework offers a chance to build stability and a foundation for cooperation in a complex post-Brexit landscape(3).
References:
- Northern Ireland Protocol: The Windsor Framework - House of Commons Library [Internet]. [cited 2025 Apr 14]. Available from: https://commonslibrary.parliament.uk/research-briefings/cbp-9736/
- The Windsor Framework - further detail and publications - GOV.UK [Internet]. [cited 2025 Apr 14]. Available from: https://www.gov.uk/government/collections/the-windsor-framework-further-detail-and-publications
- Diamond P, Colfer B. THE WINDSOR FRAMEWORK AND ITS IMPLICATIONS. 2024 [cited 2025 Apr 15]; Available from: www.triptyque.be