Tamper-Evident labels

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  • Tamper-Evident labels

Applications

Labels for Security-Pharma applications. Serialisation – Anti-tampering. 

The pharmaceutical sector must adapt to the challenge posed by the mandatory Serialisation and Traceability of Medicines according to the European Directive 2011/62/EU “Falsified Medicines Directive”, a regulation that requires the introduction of a serialisation system in products with control at the point of sale and whose objective is to guarantee patient safety. 

Compliance with this Directive is achieved by including on the label some properties that permit the “verification of whether the outer packaging of the medicinal product has been tampered with” as described in European Standard EN 16679.

At IPE, we have developed a whole range of labelling solutions designed to comply with these regulations. 

Important definitions

  • Tamper-Evident: The nomenclature given to a type of label that serves as security or evidence of opening of the container or product on which this security element is to be placed. 
  • Outer Packaging: The cardboard or plastic box containing the drug in its primary packaging. 

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