TraceLink Completes Upload Certification Tests with EMVO for Connection to the European Hub
TraceLink Inc., the world’s largest track and trace network for connecting the Life Sciences supply chain and eliminating counterfeit prescription drugs from the global marketplace, today announced that it has completed product master data and product pack data upload certification tests with the European Medicines Verification Organization (EMVO) for connection to the European Hub. The tests authenticate the ability for pharmaceutical manufacturers to use TraceLink’s EU Compliancemodule, which is now commercially available, to communicate product master data and product pack data to the EU Hub, and to meet serialization and compliance requirements under the EU Falsified Medicines Directive (FMD) nearly three years in advance of the February 2019 deadline. As a result, all pharmaceutical manufacturers can leverage their single integration to the Life Sciences Cloud to automatically access the EMVO tested capabilities by setting a few configuration flags. TraceLink’s unique network-tenant platform approach significantly reduces the time, cost and risk of achieving regulatory compliance for the EU FMD and all other countries that have requirements by eliminating the need to verify and certify point-to-point connections to each government system.
“Pharmaceutical companies face the difficult challenge of meeting a wide range of global regulations on-time, at the lowest cost and the least risk of ensuring drug supply without disruption to their operations. Our family of track and trace solutions now extends to the European Union with a tested EU Compliance platform that enables companies to get a jumpstart on preparing for upcoming 2019 deadlines,” said Shabbir Dahod, president and CEO of TraceLink. “This milestone is the result of more than two years of design, development, and testing—and close collaboration with the EMVO to gain a deep understanding of the complex rules and operational requirements for the Falsified Medicines Directive. With our EU Compliance module now live, TraceLink offers country-specific compliance software for more regulated geographies than any other track and trace provider.”
TraceLink EU Compliance: Continuous Regulatory Support on the Most Proven Track and Trace Network
The TraceLink Life Sciences Cloud is the only track and trace solution that is proven to provide pharmaceutical manufacturers with continuous continuity of drug supply to global markets that have vastly different and highly complex serialization and regulatory compliance requirements. The EU Falsified Medicines Directive adds to this complexity as the regulation spans more than 30 countries and aims to protect approximately 900 billion doses of medicine. Pharmaceutical manufacturers that ship products to the EU and choose the Life Sciences Cloud now have access to a tested EU Compliance solution that will help to eliminate business risk and ensure drug products reach patients in the most timely and cost-effective manner. Specific benefits of using the EU Compliance module include:
- An out-of-the-box, integrated EU compliance solution for the Falsified Medicines Directive—delivering a comprehensive suite of serialization, master data, verification and compliance reporting solutions available for EU compliance;
- Tested integration with the European Hub—confirming with the EMVO that product master data and product pack data uploads are consistently accurate;
- Access to more than 1,200 CMOs—accelerating EU compliance readiness through connectivity to the world’s largest collection of contract manufacturers with just a single connection to the Life Sciences Cloud platform;
- Elastic scalability to meet massive EU FMD transaction processing requirements—reducing risk by leveraging TraceLink’s cost-effective and scalable native cloud architecture through Amazon Web Services; and,
- Continuous compliance monitoring and regular software updates that guarantee EU compliance coverage—keeping your track and trace and serialization solutions secure and up-to-date should regulatory rules evolve and data exchange standards mature.
To learn more about TraceLink’s complete EU Falsified Medicines Directive solutions, or to discuss building to build a flexible global serialization, track and trace, and reporting platform, visit www.tracelink.com.