Strict requirements will apply throughout the EU as of 9 February 2019: All prescription-only medicinal products for human use have to bear safety features to ensure that no falsified medicinal products enter into the legal supply chain. AMVO (Austrian Medicines Verification Organisation) is responsible for implementing the system called for by the Falsified Medicines Directive. The association was formed by the pharmaceutical industry, medicinal product wholesalers and pharmacists in Austria in order to ensure, by introducing new safety features, that patients can place even greater trust in the authenticity of their products.
Each EU member state must establish a national repository for this purpose. The repository to be implemented in Austria will be connected to a European hub in order to ensure seamless tracing and verification of individual medicinal product packs also throughout Europe. This hub will be operated by the European Medicines Verification Organisation (EMVO).
Each individual pack is labelled with a randomised unique serial number (serialisation), which, together with its batch number and expiry date, is encoded in a two-dimensional barcode. This makes each medicinal product pack unique and traceable, not just in Austria, but throughout Europe.
Before you get a medicine handed out from a pharmacy, the serial number of the medicinal product is verified, read out from a data system and then decommissioned. Should the same decommissioned serial number appear again in a pharmacy at a later date, there is reason to suspect falsification. In such a case, the medicinal product will not be dispensed so there is no risk at all for patients.
Implementation of the system proposed in the Falsified Medicines Directive in Austria involves:
medicinal product wholesalers
million packs per year