Medicinal product packs are labelled with an unique serial number by the pharmaceutical manufacturers, who then enter that serial number into the European verification system (EU hub) and store it in a database.
Medicinal product wholesalers
The medicinal product wholesalers, who provide the link between the manufacturers and the pharmacies, will check the serial numbers in defined cases (e.g. for returned products).
Medicinal products are supplied to patients via public pharmacies, hospital pharmacies and self-dispensing doctors. Before being handed out, the serial number of each individual product pack has to be verified and decommissioned from the system.
If patients obtain medicines following this procedure, they can be sure not to receive a falsified product.
The pharmaceutical industry invests millions in protection against falsification of medicinal products. Among other things, this involves modification of entire packing lines and installing new IT systems at all the parties involved - from manufacturers to pharmacies.
All stakeholders in the healthcare sector, manufacturers, wholesalers and pharmacies together ensure, with great dedication and based on close cooperation, that the already high level of safety in the distribution of medicinal products is further improved, for the benefit of the patients.
Under the Directive, it is incumbent upon the pharmaceutical industry to ensure both the implementation and the funding of the system at the national level. This is why AMVO was founded.
Application of EU-FMD started on 9th February 2019. To guarantee a smooth start and the security of supply with medicinal products a stabilisation period of 6 months started from February 9th to August 9th 2019. During this time period all people and organisations involved have the opportunity to obtain and to correct possible process or application errors. Occurrent issues regarding data, software or handling shall not lead to any consequences.