TraceLink Customers Receive EMVO Approval for Data Submission to EU Hub
NORTH READING, Mass. — TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, today announced that it has developed a streamlined program for its more than 190 customers to rapidly complete conformance testing and successfully receive European Medicines Verification Organization (EMVO) approval to submit data to the EU Hub – a complex and lengthy process that requires each individual company to complete EMVO registration and provide a full set of test cases to be executed for conformance with the EU Hub.
In just one month, 34 companies have completed their conformance testing with TraceLink’s conformance test kit. Of these, 11 companies have received EMVO approval to submit data to the EU Hub and 14 companies are awaiting review from the EMVO. In order to achieve final approval, all pharmaceutical companies must now submit a series of transactions to be reviewed by the EMVO, a process that can now take several weeks due to the surge of companies seeking to connect to the EU Hub before the EU Falsified Medicines Directive (FMD) deadline in February 2019. Once the transactions are approved by the EMVO, a pharmaceutical company will receive access to the certificates required for production and data submission to the EU Hub.