Serialization in Life Sciences

The circulation of counterfeit drugs is a genuine danger for the safety of patients. To fight against this threat, many countries have developed – or are in the process of developing – a regulatory roadmap for serialization ...

By: Edith Oyen, Project Manager Supply Chain

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Client core business

The client is a Belgium-based pharmaceutical company that develops treatments for serious disorders and complex medical challenges such as cancer, hepatitis, HIV/AIDS, diabetes, arthritis, dementia and more.

Business issue

Counterfeit medicines entering the pharmaceutical supply chain can entail major health and safety related risks. To counteract the circulation of falsified drugs, the European Union has put a legal framework in place: the Falsified Medicines Directive (FMD).
The FMD aims at securing product authenticity by the introduction of several safety and control features, known as serialization. Each player in the pharmaceutical supply chain – from manufacturer to retailer – needs to comply to this new legislation.

How Modis Life Sciences added value

In the context of the FMD, Modis Life Sciences has helped the client to ensure end-to-end functional compliance and technical connectivity from the client (SAP ATTp, Advanced Track and Trace for Pharmaceuticals) to the National Medicines Verification Systems (NMVS) via the EU-Hub, across 30 countries in the European Economic Area (EEA).

Results

  • Improved patient safety and brand protection through detection of counterfeit drugs
  • E2E Supply Chain visibility

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