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Latest Updates, November 2024

 

Starting January 1, 2025, the UKNI Medicines Verification System (UKNI MVS) will permanently close. This closure will mark a significant shift in Northern Ireland’s pharmaceutical landscape. The decision, brought in the Windsor Framework and implemented by Regulation (EU) 2023/1182, will end all connections between the UKNI MVS and the European Medicines Verification System (EMVS). The forthcoming change is part of Northern Ireland’s alignment with UK regulatory standards.

 

Understanding the Windsor Framework and its implications

 

The Windsor Framework, adopted in early 2023, provided a post-Brexit solution to address regulatory challenges specific to Northern Ireland, including those around the Falsified Medicines Directive (FMD). Historically, Northern Ireland remained connected to the EU’s EMVS system after Brexit to ensure the authenticity of medicines flowing between NI and the EU. However, Northern Ireland will diverge from these EU standards under the new framework, signalling a new direction in medicine verification.

 

Fundamental changes and immediate impacts

 

With the permanent closure of the UKNI MVS:

 

• Severed Connections to the EU Hub: The UKNI MVS’s connection to the EU Hub will be completely severed. This means that all data in the UKNI system, including backups, will be permanently erased.
• Termination of MAH Agreements: Marketing Authorization Holders (MAHs) and end-user licenses managed under the UKNI MVS will be terminated, and the system will be shut down.
• Changes to Product Labeling: Medicines intended for the UK market must now display a “UK only” label. Any 2D barcodes aligning with EMVS standards must be removed or covered. UK-based packs will now be recognized under the UK’s regulatory system and will not trigger alerts within the EMVS.

 

Handling Northern Ireland Packs in the EU Post-Disconnection

 

The disconnection from the EMVS will also mean that UK-only packs carrying 2D barcodes may generate exceptions when scanned in EU countries.

 

 

Adapting to New Standards and Regulatory Guidance

 

 

Understanding and adapting to these regulatory changes will be critical for pharmaceutical companies and other supply chain participants. The essential part for them will be adapting to the new labelling practices, maintaining compliance, and avoiding delays. This new framework underscores Northern Ireland’s alignment with UK systems, creating a clear separation from EU processes while ensuring the continued safety and quality of medicines within Northern Ireland and the broader UK.

 

For detailed guidance and additional FAQs, please refer to the Northern Ireland Exit from the EMVS (NIXIT) Q&A. This resource offers further insights into how the Windsor Framework affects regulatory obligations and the steps companies can take to prepare for a smooth transition.