Normon Laboratories selects TraceLink to comply with EU FMD serialization regulations.
TraceLink Inc. announced that Spanish-based pharmaceutical manufacturer, Normon Laboratories, has selected its serialization solutions to comply with the EU Falsified Medicines Directive (FMD) requirements.
The first generics pharmaceutical manufacturer in Spain, Normon Laboratories has grown to be a global player, supplying products to multiple markets. With high volumes of pharmaceuticals shipped throughout Spain and exported across the rest of the world, and offering additional contract manufacturing capabilities for customers, the company needed a serialization solution that could accommodate its various roles in the pharmaceutical supply chain and ensure compliance for its customers, as well as its own product lines.
Normon said it selected TraceLink for its ability to scale at the enterprise level and its seamless integration with multiple contract manufacturing organizations, in order to enable compliance with the EU FMD serialization regulations.
With track and trace regulations that vary country to country and the impending EU FMD deadline in February 2019, life sciences companies face unprecedented complexity, cost, and risk in how they implement serialization strategies. TraceLink has processed EU compliance reports for more than 660,000 units of product into the European hub 17 months ahead of deadline, according to the company.
The TraceLink European Union Compliance module supports traceability reporting requirements from a single platform, providing 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.