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European Union Compliance

TraceLink’s European Union Compliance application helps companies across the pharmaceutical supply chain meet the existing and developing requirements of the European Union Falsified Medicines Directive (EU FMD).

The European Medicines Verification Organisation (EMVO) created the EU Hub to manage the flow of regulatory information to and from stakeholders and national systems. TraceLink’s EU Compliance application connects you to the EU Hub so you can send and receive compliance data. The EU Hub sends the data to the necessary national systems and sends data back to your EU Compliance application.

With EU Compliance, you can:

  • Send the requisite data to the EU Hub, including master data and product pack information. The EU Hub sends the data to the appropriate national systems
  • Receive acknowledgements and error responses from the EU Hub
  • Issue batch recall requests to the EU Hub
  • Request product verification from EU Hub to determine if the products you receive have valid serial numbers
  • Request information from the EU Hub, such as a report of your Master Data as it appears in the EU Hub
  • View the reports and requests you send, as well as responses, acknowledgments, and results of informational requests
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