Spanish-based pharmaceutical manufacturer, Normon Laboratories, has selected TraceLink serialisation 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 serialisation 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 ease to integrate with multiple contract manufacturing organisations, to enable compliance with the EU FMD serialisation 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.”
“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 serialisation and individual country compliance,” said Shabbir Dahod, president and CEO of TraceLink.”
Drug traceability and serialisation is a global initiative and we look forward to working closely with Normon Laboratories to meet the approaching EU FMD deadline for serialisation 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 serialisation strategies.
TraceLink has 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, serialised product pack data and status changes for products targeted for distribution across all Member States.