What is NMVS?
NMVS stands for National Medicines Verification System: the national database that stores the unique codes printed on packs of prescription medicines. Together with the EU hub run by the European Medicines Verification Organisation (EMVO), the national systems form the EU verification network required by the Falsified Medicines Directive. Pharmacies and wholesalers scan a pack's code to check it against the NMVS and decommission it when the pack leaves the supply chain.
Source: Commission Delegated Regulation (EU) 2016/161 on safety features for medicinal products
T. LozerCompliance Strategy Specialist · entroit GmbH
· Updated
How the verification system works
The Falsified Medicines Directive (Directive 2011/62/EU) and Delegated Regulation (EU) 2016/161 have required two safety features on most prescription medicines since 9 February 2019:
- a unique identifier in a 2D Data Matrix code: product code, serial number, batch number and expiry date, plus a national reimbursement number where a country requires one
- an anti-tampering device that shows whether the pack has been opened
The manufacturer or marketing authorisation holder uploads every unique identifier to the EU hub, which passes it to the national system of each market where the pack may be sold. The NMVS then answers every scan: the code is active, already decommissioned or unknown. The pharmaceutical industry sets up and funds the system. Germany’s national system is securPharm.
What wholesalers have to do
| Situation | Duty under Regulation (EU) 2016/161 |
|---|---|
| Returns from pharmacies or other wholesalers | Verify the code before the pack goes back into saleable stock |
| Packs bought from a wholesaler that is not the manufacturer, the marketing authorisation holder or a designated wholesaler | Verify the code on receipt |
| Export outside the EU, destruction, samples for authorities | Verify and decommission the code |
| Damaged anti-tampering device or suspected falsification | Do not supply, inform the competent authority |
A decommissioned code can be reactivated within ten days, under strict conditions. Pharmacies decommission the code when they hand the medicine to the patient.
Parallel importers have an extra duty. When they repackage, they verify and decommission the original codes and apply new safety features, which then go into the system like a manufacturer’s.
What NMVS means for your warehouse system
FMD compliance happens at the scanner, not in a separate portal. In inventory management for pharmaceutical wholesale, the goods receipt and the returns process should trigger the NMVS check, put a pack with an unexpected status into quarantine and record the result in the audit trail. For parallel import, the system also has to link the old and new codes to the same batch. entroit connects to securPharm and the EMVO; the verification duties remain those of your business.