All organisations that manufacture, sell or dispense medicinal products in EU Member States have until February 9, 2019 to comply with the Falsified Medicines Directive (FMD), which requires that an end-to-end verification system be in place for an individual pack of a medicinal product for the entire time it’s in the market, including any time necessary for returning and disposing of the pack after it has expired.
Whether you are a European marketing authorisation holder, contract manufacturer, contract packager, wholesaler/distributor or parallel importer/distributor, OPTEL can help you achieve FMD compliance rapidly.
Wholesalers engage in a wide range of activities including purchasing, warehousing, storage, order preparation and delivery of medicines. Global compliance mandates can be complicated and difficult for wholesalers to understand. In certain situations, wholesalers and distributors must verify the authenticity of a unique identifier associated with certain medicinal products in their physical possession, which will significantly affect their operations.
Our expertise with serialisation and Track&Trace is unparalleled: we are the number one Track&Trace solution provider in the world with the largest global market share. During the past three decades, we have helped countless pharma organisations achieve their compliance objectives rapidly by providing proven solutions and ongoing, dedicated resources. OPTEL’s full stack, end-to-end traceability solution for compliance offers: