Serialisation and Track&Trace Solutions for European Wholesalers and Distributors

EU FMD COMPLIANCE - WHat does it mean for you?

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.

Wholesaler and Distributor Challenges: Regulatory Compliance

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.

How OPTEL Can Help

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:

  • A one-stop-shop for rapid, seamless EU FMD compliance, including:
  • Industry-leading automated vision inspection systems
  • Cloud-based serialisation software that is flexible, robust, mature and can interface seamlessly with trading partners, the EU Hub and national systems
  • Advanced analytics and real-time reporting
  • User-friendly industrial, GMP-compliant and easy-to-integrate solution that connects with an existing warehouse management system and ERP, including warehouse handheld scanners
  • Solution features include: decommissioning, verification, aggregation support, serial number destruction, offline capability, receiving and return management.
  • Complete project management, including dedicated solution architects and in-house validation resources
  • Global, ongoing support
  • A fixed annual price that allows you to precisely budget for the solution cost

Learn why OPTEL's EU FMD compliance solution is the gold standard of Track&Trace solutions.