In line with 28 other European countries, Belgium started implementing the Falsified Medicines Directive (FMD) on 9 February 2019.
This European Directive provides additional security for all (prescription and reimbursable) medicine packagings to ensure their authenticity, safety and quality.
To this end, databases are operational at both European and Belgian level, on which a unique code is loaded and verified for each medicine packaging. This new code is activated on the database by the medicine manufacturers via a secure network.
Upon delivery to the patient in a pharmacy or hospital, this unique code on the medicine packaging is scanned, compared with the code in the database and, if identical, deactivated.
Thus, the authenticity of each medicine can be guaranteed upon delivery.
THE EUROPEAN MEDICINES VERIFICATION SYSTEM (EMVS)
Below is a schematic representation of how the EMVS System works
MEDICINES VERIFICATION SYSTEM - BASIC PRINCIPLES
The drug manufacturer or parallel importer applies a unique code in a 2D matrix code to each drug package released to the pharmaceutical supply chain (together with an anti-tampering device or ATD anti-tampering device)
The unique codes (product code + serial number of the drug package) are stored (along with the batch ID and expiry date) in a central database.
The medicine package is delivered to the patient. The pharmacist scans the 2D matrix code printed on the drug pack. The scanned data is transmitted to the central database.
Wholesalers only need to verify the authenticity of the medicine packaging in specific situations, based on risk.
The central database checks whether the unique code exists, whether it is still “active” (not deactivated) and/or whether the additional information (batch ID and expiry date) matches the information transmitted.
The central database sends the result of the verification back to the pharmacist and reports whether the drug pack can be dispensed or whether it may be a counterfeit.
In each European country, there is a national repository (NMVS – National Medicines Verification System) for the end users of the system (wholesalers, pharmacies, etc.).
The different systems are connected through a European hub.
Manufacturers and parallel importers upload the FMD data via the EU-Hub to the national systems.
End-users connect to their country’s national system.
The link between the different national systems via the EU-Hub also enables the monitoring of medicines imported from another country.
The EU Hub is managed by the EMVO (European Medicines Verification Organisation).
EMVO is a Belgian not-for-profit organisation representing stakeholders who want to safeguard the legal supply chain from falsified medicines.
The 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)
- AFFORDABLE MEDICINES EUROPE (The European Association of Euro-Pharmaceutical Companies)