TraceLink Inc. today 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 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.
“At Normon, we uphold our commitment to developing the safest and highest quality medicines at affordable prices for everyone. Our dedication to ensuring patient safety was a key factor in selecting a partner with a proven solution to comply with the EU FMD,” said Gonzalo Fernández Govantes, Chief Operating Officer of Normon Laboratories. “We selected TraceLink for its demonstrated EU and country compliance capabilities and enterprise scalability. As Normon continues to expand its business through ongoing innovation, we are confident that TraceLink can provide the breadth of support needed in order for Normon to successfully comply with EU and global regulations.”
“We are pleased to be working with Normon Laboratories, a pioneer in the development of generic medications, and one of the leading pharmaceutical companies in Spain. At TraceLink, we understand and value the need to implement an EU FMD compliance strategy that can scale quickly to accommodate for rapid growth and impending deadlines for serialization and individual country compliance,” said Shabbir Dahod, president and CEO of TraceLink. “Drug traceability and serialization is a global initiative and we look forward to working closely with Normon Laboratories to meet the approaching EU FMD deadline for serialization and ultimately, help secure the integrity of its products for patients across Europe.”
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 already processed EU compliance reports for more than 660,000 units of product into the European hub 17 months ahead of deadline. 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.