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Pharmaceutical Manufacturing and Packing Sourcer

Is Europe Ready?

February saw an important milestone for all pharmaceutical manufacturers supplying the European market and their supply chain partners – the 9th marked the beginning of the two-year countdown until the EU’s Falsified Medicines Directive (EU-FMD) compliance mandate comes into force across Europe. From that date, pharma companies will no longer be able to legally put products on the European market unless they comply with the three critical ‘safety features’ requirements. Every pack of medicines must be:
  • Tamper-evidenced
  • Carrying a 2D data matrix encoding a unique identifier (UI)
  • The UI must have been uploaded into a Europe-wide system of repositories for systematic check-out at pharmacies
Achieving readiness to fulfil these conditions is a huge undertaking and the question being asked is: ‘How realistic is the prospect that Europe will be ready in February 2019?’ In order to answer this, let us consider the different areas of work in turn.

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Christoph Krähenbühl, Senior Director at 3C Excellis Europe, is widely recognised as a thought leader in pharma serialisation. He has been involved in serialisation schemes since 2006 as Serialisation Project Manager and Product Security Manager at AstraZeneca. Christoph has also been supporting the European stakeholder response to the EU-FMD as an expert on the European Federation of Pharmaceutical Industries and Associations team and as a member of the EMVO management team.
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Christoph Krähenbühl
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