Every prescription pack in Europe now carries a unique code and a tamper-evident seal. For companies supplying Greece, the country’s late arrival to this system makes getting it right especially important.
The Falsified Medicines Directive (2011/62/EU) and its Delegated Regulation (EU) 2016/161 introduced two safety features on most prescription medicines across the EU from 9 February 2019: a unique identifier encoded in a 2D Data Matrix, and an anti-tampering device.
How verification works
The system rests on the European Medicines Verification System, governed by EMVO. Manufacturers upload identifier data to a central EU Hub, which connects to national verification systems. Pharmacies and wholesalers verify and decommission the unique identifier when a pack is dispensed — confirming it is genuine and has not already been supplied.
Greece went live in 2025
Greece operated under a national derogation and was among the last Member States to implement. The Hellenic Medicines Verification Organisation (HMVO) was established in late 2023, and the Hellenic Medicines Verification System became fully operational on 9 February 2025. Companies that treated Greece as exempt have had to move quickly.
The Greek specifics
Alongside the EU safety features, Greece requires the national EOF product code for all medicines, with tracking and reporting obligations that apply from the system’s go-live. Both serialised and non-serialised products carry duties — a nuance that catches out companies applying a purely EU-level checklist.
Stabilisation is the current focus
As with every newly live national system, the operational priority now is handling verification alerts and bedding in the connections between manufacturers, wholesalers and pharmacies. Alerts are a normal part of a maturing system, but they need managing.
How PQRA helps
PQRA supports serialisation compliance, HMVO onboarding, EOF coding obligations and alert management for the Greek market.
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