Wholesalers are important stakeholders in the EU’s Falsified Medicines Directive (FMD) by warehousing, transporting and delivering pharmaceuticals. They typically sit between the manufacturers and the pharmacies providing an important service. Wholesalers must authenticate the products received from their suppliers (if not directly coming from the Marketing Authorization Holder (MAH) or their dedicated Wholesalers) or returns by verification, or decommission/re-commission (within 10 days after a decommission) the product serial number in the National Systems with the correct reason code.
Complying with the FMD requires a connection to the National Medicines Verification System (NMVS) in the country your warehouse is located. This connection enables you to handle the product through scanning of the 2D barcode for verification, decommissioning and recommissioning.
Establish a direct connection to your NMVS and verify if a returned product is still active in the supply chain. Deactivate products when needed, for example, in case the product is a free sample, it has been stolen or is exported outside the European Union. Multiple NMVS connections are possible.
Solidsoft Reply
is one of the IT software providers that have engineered a National Blueprint System. Upon registration, you are given a unique registration code that you input into Movilitas.Cloud. Below is the list of countries Solidsoft Reply works with:
Arvato
is another National Blueprint Service Provider and has been implemented in 17 countries:
Netzgesellschaft Deutscher Apotheken
NGDA provides N-Ident credentials (user name, password and e-certificate) so you can access securPharm, the German verification system.
Every wholesaler must verify each package that was not acquired directly from a manufacturer or their Marketing Authorization Holder, or that was returned from another wholesale dealer, distributor or pharmacist. What you need is scanning software that checks every code in the database of the national system.
Keep all scans in a dedicated FMD repository for later reporting and analysis
The FMD reports application provides an audit trail of every pack that was scanned at least once. For customers having an FMD repository, extensive reporting capabilities are available free of charge.