The European Falsified Medications Directive came into effect on February 9, 2019. From that time most of the prescription and reimbursable medicines on the market must bear safety features. At each link in the distribution chain, the safety features must be checked so that the authenticity of the medicine upon delivery can be guaranteed.
The safety features consist of a unique, two-dimensional matrix code and an “anti-tampering device”. The unique matrix code is activated in a database by the drug manufacturer via a secured network. The wholesaler checks this code and, when being delivered to the patient in a pharmacy or in the hospital, this unique code on the package is scanned and compared to the code in the verification system. The control makes it possible to protect the patient and pharmaceutical sector from falsified medicines and counterfeits. The anti-tampering device is a seal, label or blister line so that a package cannot be opened unnoticed.
The Falsified Medicines Directive requires that the verification system must be developed by the sector itself. In Belgium, the pharmaceutical sector has set up the vzw BeMVO (Belgian Medicines Verification Organisation). The cost of the set-up of the Belgian verification system is borne by the pharmaceutical industry in Belgium and the patient pays no costs for this.
BeMVO has created an "alert” procedure together with the Federal Agency for Medicines and Health Products (FAMHP) for “alerts” or error messages when a product is scanned. This step procedure, the first of its kind in the entire European Union, must be followed in the case of error messages when products are scanned. Experience in the development and testing of the system has shown that above all in the first weeks after the system becomes operational, one can still expect some error messages not related to forgeries. The FAMHP has bundled a few practical guidelines for handling the problems in the start-up phase in a circular (Dutch or French only). Drugs sold before February 9, 2019 which do not yet have the code on the packaging may of course still be delivered to the patient.
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BeMVO (Belgian Medicines Verification Organisation)
Guideline 2011/62/EU of Falsified Medicines Directive, FMD
FMD circular 644 (Dutch or French only)