FMD – Falsified Medicines Directive
Because Patient safety is of the utmost importance for Belgium and the European Union, the EU Commission introduced the Directive 2011/62/EU to prevent falsified medicines from entering the legal supply chain. The EU Commission also published the Delegated Regulation (EU) 2016/161 containing the operational specifications for the verification system.
The European Medicines Verification System (EMVS)
The basic principle of the Medicines Verification system
The pharmaceutical manufacturer or parallel importer applies a unique code in a 2D matrix code on each pack that will be released for the pharmaceutical supply chain (together with a anti-tampering device).
The unique codes (product code + pack serial number) are loaded in a central repository (together with the batch ID and the expiry date).
When the pack is delivered to the patient, the healthcare professional scans the 2D matrix code that is printed on the pack. The scanned data are transmitted to the repository.
Wholesalers need only to verify the authenticity of the pack in specific situations based on the risk.
The repository verifies if the unique code exists, if that code is still in an ‘active’ state (has not been deactivated) and if the additional information (batch ID and expiry date) correspond to the information stored in the repository.
The repository send the result of the verification back to the healthcare professional informing if the pack can be delivered or if it is a potential falsification.
There is a national repository (NMVS – National Medicines Verification System) for the system end-users (wholesalers, pharmacies, …) in each country.
The different systems are linked together through a European hub.
- Manufacturers and parallel importers upload the FMD data through the EU Hub to the national systems.
- The end users connect to the national system for their country.
- The link between the different national systems through the EU Hub allows also the verification of pharmaceuticals that are imported from another country.
The EU Hub is managed by EMVO (European Medicines Verification Organisation).
The EMVO is a Belgian non-profit organisation representing stakeholders united in securing the legal supply chain from falsified medicines.
Its founding members of EMVO are
- EFPIA (The European Federation of Pharmaceutical Industries and Associations),
- Medicines for Europe (The European Generic and Biosimilar Medicines Association),
- PGEU (The Pharmaceutical Group of the European Union),
- GIRP (The European Healthcare Distribution Association) and
- AFFORDABLE MEDICINES EUROPE (The European Association of Euro-Pharmaceutical Companies)