Seamless Integration to the EU Hub and National Systems
Parallel Importers play an important role in the European pharmaceutical supply chain, buying product and transforming it into new entities for resale. The specific EU FMD compliance requirements for parallel importers depend on the how and from whom products are purchased, and whether or not any repackaging is outsourced to CMOs.
While the specific requirements will vary from company to company, those that purchase product from manufacturers will have to decommission the units that they plan to repackage and distribute, as well as scan and verify the authenticity of products that they purchase from wholesale distributors.
TraceLink enables any parallel importer to connect to our network for instant integration with the EU Hub for the purpose of reporting product master data and pack data, and to any required national systems for risk-based verification and decommissioning. Those that sell product into multiple countries will benefit from a single integration to TraceLink for all of their national system requirement, eliminating the need to create and maintain individual, point-to-point connections to each county’s national system.
Rapid Connectivity to CMOs for Serialized Production
Parallel importers that outsource any of their repackaging functions to CMOs will need to exchange serialization data with those businesses to ensure that any new product they create is serialized according to EU FMD requirements.
With 850+ CMOs currently on the TraceLink network, parallel importers only need a single connection to TraceLink in order to begin exchanging serialization data. Once the new product is serialized and ready to be sold to distributors or pharmacies across the region, the TraceLink network will communicate the necessary product master data to the EU Hub to ensure that EU FMD compliance has been achieved.