FMD Connect Standalone System for Wholesalers

Wholesalers have in a general way the same obligations as the manufacturers (except that they don’t place any products in the market), which is to secure the supply chain and to verify any suspicion of falsified medicines. This boils down to authenticating the products that are returned by verification in the National System or deactivation/re-activation (within 10 days after deactivation) the product serial number in the National Systems with the reason code.

There is also a requirement for wholesalers to implement a ‘risk based’ approach to verification and decommissioning of product passing through their operation. They will also have to decommission products on behalf of some of their customers who do not operate within a healthcare institution or a pharmacy but who nevertheless use or supply medicines on an occasional basis (e.g. Police, Schools, Prisons etc.)

To achieve compliance by February 2019, wholesalers will need to implement a system that enables verification, decommissioning or recommissioning of packages, linking with the respective country’s national hub.

ATL FMD Connect Solution is an easy to use secure cloud-based application, that enables Pharmaceutical Wholesaler / Distributor to Verify or Decommission the pack along with export functionality according to the Falsified Medicines directive.