European Union

Falsified Medicines Directive (FMD)

The life sciences industry must navigate a complex network of regulations when operating or selling in Europe. The European Union’s Falsified Medicines Directive took effect in February 2019. This legislation requires pharmaceutical companies to verify the authenticity of each medicinal product manufactured or distributed in Europe. This item-level serialization poses some serious operational challenges for each of the stakeholders.

Key Challenges Solved with Movilitas.Cloud

  • Ensuring product authenticity and integrity
  • Maintaining visibility and traceability throughout the supply chain
  • Investigating and removing illegitimate products
  • Serializing products

Though these challenges may seem daunting, Movilitas.Cloud is the expert solution that addresses them all. The application’s digitalized tracking and tracing options enable efficient serialization of products, simplify the required FMD 2D barcode system and make the process streamlined, reducing the risk of supply chain disruptions. Movilitas.Cloud connects to the EU Hub and to all National Medicine Verification Systems which simplifies reporting of falsified medicines. This integration can streamline recalls, which in the past have been difficult to regulate. As soon as a falsified or counterfeit product is suspected, products can be easily recalled before they reach a patient, thereby increasing safety and safeguarding public health.

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