All organizations that manufacture, sell or dispense medicinal products in EU Member States have until February 9, 2019 to comply with the Falsified Medicines Directive (FMD). The FMD not only ensures that medicinal products distributed in the EU are safe, it will attempt to mitigate rising costs for supply chain organizations that are a result of different national or regional traceability requirements and authentication mechanisms.
FMD requires that an end-to-end verification system is in place for an individual pack of a medicinal product for the entire time it’s in the market, as well as any time necessary for returning and disposing of the pack after it has expired. The legislation applies only to prescription medicines unless the product is considered at risk of counterfeiting.
Download our key differentiators PDF to learn what sets our serialization software apart.
Our flexible cloud-based enterprise platform can facilitate seamless interaction with your supply chain partners early and often in the planning process. OPTEL’s Verify Brand® Software can store and pass along all the data national regulations require, including any additional data that must be printed on the cartons. It accommodates both standard (EPCIS) and non-standard communication protocols and enables true randomization to support FMD compliance without number waste so you experience maximum flexibility in your dataset configurations.
By leveraging serialization data with our built-in smarter reports and analytics, you’ll save time on hours spent manually compiling and interpreting data.
Serial numbers are generated from the our platform and the CMO / packaging line returns serial numbers used in production.
Using our standards-based Partner Integration Module, the Verify Brand Software sends the serial numbers to the Central EU Hub, which serves as routing point for serial numbers to National Hubs.
Dispensers use the National Hubs to verify serial numbers. National Hubs update the Central EU Hub, which in turn notifies other national systems that dispensed serial number is valid.
National systems allow pharmacies or other registered parties (wholesalers, self-dispensing doctors or hospital pharmacies) to check a product’s authenticity.