Northern Ireland (NI) has exited the European Medicines Verification System (EMVS). This change impacts how medicines are verified and dispensed in Northern Ireland. For detailed guidance on this topic, please refer to this official Q&A document provided by EMVO.
Key Points:
NI's Exit from EMVS: As of 1 Jan 2025, Northern Ireland is no longer part of the EMVS. This means pharmaceutical products dispensed in NI are no longer required to be verified through the EU FMD system.
Impact on OBPs and NMVOs: OBPs (Onboarding Partners) and NMVOs (National Medicines Verification Organizations) are no longer responsible for uploading Northern Ireland-related data to the EMVS.
Compliance Requirements: Medicines dispensed in Northern Ireland must now follow the specific regulatory framework outlined by the UK authorities, separate from EU FMD compliance.
Future Plans and Adjustments: OBPs and NMVOs should stay updated on potential regulatory changes and any requirements that may arise post-exit.
Additional Information:
For more detailed explanations on the Northern Ireland exit from EMVS and its implications, please consult the official EMVO Q&A document available here.
If you have any questions or need further assistance, feel free to contact the EMVO Service Desk:
Email: helpdesk@emvo-medicines.eu