With the Falsified Medicines Directive (FMD) published in July 2011, the European Medicines Agency (EMA) set the beginning of traceability standards of the countries in the European Union.
The Falsified Medicines Directive (Directive 2011/62/EU) introduces harmonized European measures to fight medicine falsifications and ensure that medicines are safe and that medicines in trade circulation are strictly controlled. Measures include:
As of 2019, all of the pharmaceutical products have to fully meet the FMD obligations. Until 2025, EU countries with a separate system such as Greece and Italy must be fully compliant with the pharmaceutical track and trace regulation.
According to EU FMD, serialization must appear at the secondary or saleable-unit level in Europe. To enable verification, manufacturers need to first serialize product and send that serialized data to a central repository that can perform queries against it.
To enable serialization, verification, and reporting to Authorities, EU FMD requires that manufacturers mark packages with 4 data elements, stored in a GS1 2D DataMatrix code:
Pharmaceutical manufacturers and parallel traders must report data to a central EU Hub run by the European Medicines Verification Organization (EMVO), which also onboard users into the Hub. This will push data down to appropriate data repositories run by corresponding National Medicines Verification Organizations (NMVOs), which are responsible for end-user onboarding and for the operation of the national systems.
Under EU FMD, Marketing Authorization Holder (MAH) is required to submit product master data and serialized product pack data.
Master data includes:
Serialized product pack data includes: