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The EU Directive 2011/62 in brief

In the European Union, pharmaceuticals will be subject to traceability. From February 2019, pharmaceutical companies will have to provide the drug packs with two safety features.

Almost all Rx drugs and high risk OTC drugs are affected. A randomized, single-pack serial number is applied to the package together with other components as a 2D data matrix code. This "pharmaceutical serialization" by means of individual coding enables the authenticity test of each individual package.

In the pharmacy, the code is scanned and verified before the drug is dispensed. To this end, the pharmaceutical companies must first report the data requiring verification to an IT system implemented by the pharmaceutical associations. In addition, the pharmaceutical packs are to be equipped with a tamper protection. This ensures that the medicinal product packaged by the manufacturer is actually present in the packaging. The European Union has launched the EU Directive 2011/62 / EU and has made it more specific by Regulation (EU) 2016/161.

Individual positioning on the packaging considering packaging dimensions, labeling and inspection systems. Individual formats, shapes, materials as well as additional safety features are possible.

  • Guaranteed quality
    – Druckqualität gemäß ISO-15415
    – Grading A
    - readability of at least 5 years.
    - 100% quality and read control
    - comparison of plain text & coding
  •  Ensure a permanent application
  •  Manual & mechanical application possible
  •  No coating clearance necessary
  •  If necessary serial number management /-generation
  •  Optimized order processing
  •  Just-in-time delivery
  • Secure supply chain
Tamper-proofing according to EN 16679:2014 - Our Tamper evident labels provide visible and irreversible evidence that no intervention in the serialized pharmaceutical packaging has been carried out.
  • Individual punching (shape / formats) according to your packaging design
  • Perforation as manipulation proof
  • Perforation to opening aid
  • Manual & mechanical application possible
  • No coating clearance necessary
  • Wide range of materials
  • If required, printing (logo, text, etc.)
  • Bei Bedarf weitere Sicherheitsmerkmale integrierbar (Sicherheitsfarben, Mikrotexte, Guillochen, Sicherheitsstanzungen, etc.)
Universal solution for every serialization case, e.g. folding cartons, special formats, manual packaging, small batch sizes, re-packaging or your special case.
  • Guaranteed quality
    - print quality according to ISO-15415
    - at least level 2
    - Readability of at least 5 years.
    - 100% quality and read control
    - comparison of plain text & coding
  • Ensure a permanent application of the serialization
  • Manual & mechanical application possible
  • No coating clearance necessary
  • If necessary serial number management / generation
  • Optimized order processing
  • Just-in-time delivery
  • Secure supply chain

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