Since February 2019, almost every prescription medicine pack in the EU has carried two safety features — a unique 2D barcode and an anti-tampering device — designed to keep falsified medicines out of the legal supply chain. Compliance is not a one-off packaging change but an ongoing obligation that touches manufacturing, data management and the wider distribution network.
The legal framework
The Falsified Medicines Directive (2011/62/EU) introduced harmonised measures across the EU to protect patients from falsified medicines. Its detailed rules on safety features are set out in Commission Delegated Regulation (EU) 2016/161, which has applied since 9 February 2019. Together they require two safety features on the packaging of most prescription medicines:
- a unique identifier — a 2D data-matrix barcode carrying a product code, a randomised serial number, batch number and expiry date; and
- an anti-tampering device that shows whether a pack has been opened.
How verification works
The system is built on an end-to-end verification model. Manufacturers upload the unique identifiers to a shared repository — the European Medicines Verification System (EMVS) — which connects to national verification systems. At the point of dispensing, a pharmacy scans the barcode, checks it against the database and decommissions it, so the same identifier cannot be reused. A now well-established European network links thousands of manufacturers, wholesalers and pharmacies to this system.
What it means for marketing-authorisation holders
Responsibility for the data underpinning the system rests largely with the marketing-authorisation holder:
- generating compliant unique identifiers and applying them at the point of manufacture;
- uploading and maintaining accurate product master data in the EMVS;
- managing alerts when a pack fails verification, which must be investigated;
- coordinating with contract manufacturers and packaging sites to ensure serialisation is applied correctly.
Common compliance gaps
- Inaccurate or incomplete master data, which generates false alerts and disrupts dispensing.
- Weak processes for investigating and resolving alerts, which can be an early signal of falsification.
- Poorly defined responsibilities between the MAH, contract manufacturers and on-boarding partners.
- Overlooking national variations in scope and implementation across member states.
How PQRA helps
PQRA helps marketing-authorisation holders and manufacturers meet their obligations under the Falsified Medicines Directive — from serialisation and EMVS on-boarding to master-data management, alert handling and the technical agreements that keep contract sites compliant. We help you treat safety-feature compliance as an ongoing quality process rather than a one-off project.
Contact PQRA for support with serialisation and FMD compliance.
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