This guide covers EU FMD compliance requirements for pharmaceutical manufacturers and marketing authorisation holders (MAHs).
Manufacturer Obligations
- ☐ Apply unique identifier (UI) and tamper-evident feature to all prescription medicines
- ☐ Register with the European Medicines Verification Organisation (EMVO)
- ☐ Upload UIs to the European Hub before product release
- ☐ Ensure DataMatrix barcode meets ISO/IEC 15415 print quality standards
- ☐ Implement serialisation management system for UI generation and management
NMVS Registration
Manufacturers must register with the national medicines verification systems (NMVSs) in each EU member state where their products are sold. NMVS registration typically requires: company registration; product registration; and technical onboarding (API integration or manual upload). EMVO provides a single onboarding process for the European Hub, which distributes data to all NMVSs.
Verification at Dispensing
Pharmacies and hospitals must verify the UI of each prescription medicine before dispensing by scanning the DataMatrix barcode and checking it against their national NMVS. Verification confirms that: the UI exists in the NMVS; the UI has not been previously decommissioned; and the product details (GTIN, lot, expiry) match the NMVS record. Failed verification must be reported to the national competent authority.