Thursday 4 June 2015

EU vs US: What are the New Track and Trace Requirements?

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The European Commission and the FDA are fighting 
counterfeit medicines through traceability 
requirements in the pharmaceutical supply chain.
by Wolfgang Schmitt
Director Operations
CONCEPT HEIDELBERG GmbH 


In 2011, the European Commission published Directive 2011/62/EC, the so-called Falsified Medicines Directive (or FMD).One goal was the fight against counterfeit medicines through serialization and verification. In 2014 the technical characteristics of these key ideas were defined, the unique identifier (UI), delivering the possibility of verification of the authenticity of single folding boxes. The unique identifier contains information on the:


  • Manufacturer product code
  • Serial Number
  • National reimbursement number, if present
  • Batch Number
  • Expiry Date

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