The Windsor Framework (WF), which came into effect on January 1, 2025, is a significant agreement between the UK and the EU that replaces the Northern Ireland Protocol. It aims to address the challenges posed by Brexit, particularly in the movement of medicines between the Republic of Ireland and Northern Ireland. Here are the key points:
1. Regulatory Alignment for Medicines in Northern Ireland
- UK Regulatory Oversight: Northern Ireland will follow the same UK medicines regulations as the rest of the UK. Medicines authorized for the UK market, including those from Great Britain, will be available in Northern Ireland without separate EU authorizations.
- No Dual Regulatory Regime: The WF ensures Northern Ireland remains within the UK’s regulatory regime for medicines, avoiding the complexity of following both UK and EU standards.
2. Guaranteed Supply of Medicines
- Unrestricted Access to UK Markets: Northern Ireland will have unrestricted access to medicines from Great Britain, ensuring no disruptions in the supply chain.
- Importation into Northern Ireland: Clear rules are established to ensure easy supply of medicines from Great Britain to Northern Ireland, preventing regulatory divergence or additional customs checks.
3. Continued Access to the EU Market for Medicines
- Dual Market Access: Northern Ireland will follow UK rules for medicines but will still be treated as part of the EU’s Single Market for Goods. This allows uninterrupted trade of medicines between Northern Ireland and the Republic of Ireland, as well as the rest of the EU.
4. Specific Labelling and Packaging Requirements
- Labelling Requirements: Medicines moving between Great Britain and Northern Ireland will have specific labelling to meet both UK and EU standards. The WF simplifies these processes to avoid unnecessary bureaucracy.
- Packaging: Outer labels for products in Northern Ireland and Great Britain will carry “UK only” and do not require the 2-D matrix serialization safety feature required by the EU’s Falsified Medicines Directive. Over-labelling is permitted but must be performed on a site with a valid manufacturing authorization and preapproved by the HPRA.
5. Implications for the Republic of Ireland
- Cross-Border Trade: The open land border between the Republic of Ireland and Northern Ireland remains unaffected, allowing for the continued free movement of medicines. Cross-border trade of medicines will remain largely unchanged.
Conclusion
The Windsor Framework ensures that the movement of medicines between the Republic of Ireland and Northern Ireland will be largely unaffected, maintaining cross-border supply chains. Northern Ireland will benefit from UK regulatory oversight while maintaining access to the EU Single Market, allowing medicines to move freely with minimal disruption. This agreement aims to create stability and certainty in the supply of medicines post-Brexit.