Tamper-Proof Labeling of Pharmaceutical Packaging According to the European Directive 2011/62/EU on Falsified Medicinal Products


The objective of the European Directive 2011/62/EU on falsified medical products is to prevent the counterfeiting of prescription and high-risk non-prescription 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 make it easy to detect attempts to tamper by opening the packaging.

A definition of these features is provided by the EU standard EN 16679 “Packaging – Tamper verification features for medicinal product packaging”.

Our products Pharma 404425 and Pharma 404427  are designed to ensure tamper-proof marking on pharmaceutical folding cartons and thus support compliance with the Directive on falsified medicinal products. Security labels ensure that the packaging board tears in a fiber-destroying manner when it is attempted to remove the label which provides clear evidence of the tampering attempt.

myLabels does not only offer label development and production, but also acts as commercial agency for thermal transfer printers and labelers of the company cab Produkttechnik GmbH & Co. KG. Service and maintenance of these printing systems are also in good hands with us.

Tamper evident identification marking

Material / Ribbon Combination That Meets the Requirements of EU Standard EN 16679


Label material:

  • Pharma 404425
    Polymere white glossy, strong adhesion

  • Pharma 404427
    Polymere transparent, strong adhesion

Ink ribbon:

  • myLabels S600
    Resin, black, inside or outside winding, 360m

Other Label Applications in the Pharmaceutical Industry

Product Identification Marking

Barcode Labels

We will gladly work with you on a customized solution if you cannot identify yourself with any of the industries mentioned above.

Address

myLabels GmbH
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D-76877 Offenbach

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+49 (0) 6348 95 95-55

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+49 (0) 6348 95 95-50

or via email to info@myLabels.de