Tamper-proof labeling of pharmaceutical packaging according to the Falsification Directive 2011/62/EU

The Falsified Medicines Directive 2011/62/EU aims to prevent the counterfeiting of prescription and high-risk over-the-counter medicines.It includes two requirements, which had to be implemented by February 2019:

  1. Pharmaceutical packaging must be marked with an individual serial number to ensure traceability back to the manufacturer.
  2. In addition, the packaging must have features that detect any attempt to tamper with it by opening it.

A definition of these features is provided by the EU standard EN 16679 “Packaging – Features for checking tamper evidence on pharmaceutical packaging”.

Our products Pharma 404425 and Pharma 404427  are designed to provide tamper-evident labeling on pharmaceutical folding cartons, supporting compliance with the Anti-Counterfeiting Directive. The security label ensures that the packaging carton tears in a fiber-destroying manner when an attempt is made to remove it, thereby providing clear evidence of tampering.

In addition to label development and production, we offer as a commercial agency of the company cab Produkttechnik GmbH & Co. KG, we offer thermal transfer printers and labelers. Service and maintenance of the printing systems are also in good hands with us.

Tamper evident identification marking

Material- ink ribbon combination that meets the requirements of the EU standard EN 16679.

Label material:

  • Pharma 404425
    Polymere white glossy, permanent adhesive

  • Pharma 404427
    Polymere transparent, permanent adhesive

Ink ribbon:

  • myLabels S600
    Resin, black, inner and outer winding, 360m

Other label applications in the pharmaceutical industry

Product identification marking

Barcode labels

We would be happy to work out a special solution with you if you cannot identify with one of the industries mentioned.


myLabels GmbH
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+49 (0) 6348 95 95-55


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