The largest market, with unique new challenges.
Companies who manufacture, sell, or dispense medications in the European Union have until February 2019 to comply with track and trace regulations outlined in the Falsified Medicines Directive (FMD), including serialization, compliance reporting, and verification requirements. Medications in Europe are generally packaged and sold at the “unit of use” level, so the volume of product that needs to be serialized and the magnitude of transactions will be two to five times what companies will see in the U.S. where the saleable unit is in larger bulk quantities. Overall, the universe of data to be produced, managed, and reported on will be massive, with the added complexity that each EU Member State is provided flexibility to apply their own unique requirements.
Providing a proven, end-to-end solution.
European Union Compliance
TraceLink’s European Union Compliance module supports traceability reporting requirements from a single platform, providing our customers with a tested integration to the European hub for reporting information about their product master data, serialized product pack data, and status changes for products targeted for distribution across all Member States. This is an important capability because it ensures that our customers can distribute their products into any market by supporting the target market data in our reporting so that the pack data is appropriately distributed to the right national system. In addition, EU Compliance manages notifications, receipts, and exceptions so that daily operations remain compliant. Nearly 18 months ahead of the EU FMD deadline, TraceLink has already managed EU compliance reports for 667,000 units of product into the EU Hub.
TraceLink’s serialization applications provide a comprehensive solution for serialized product management, including the ability to generate and manage serial numbers, exchange serial numbers and events with packaging sites and line management systems, track serialized inventory operations across plant and warehouse operations, and automatically trigger compliance activities. For manufacturers who need to serialize product, our end-to-end serialization solutions support global standards as well as country-specific formats. So whether you serve a few countries in the EU or multiple countries across the world, TraceLink empowers you to meet evolving regulations.
Compliance and Digital Information Platform for European Pharmacies
The first of its kind, this mobile and web-based application provides a single destination for pharmacies to comply with verification and decommissioning requirements under the FMD while accessing a real-time dashboard for business insights on medicine scans, expiry dates, dispensation trends, product inventory and more.