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New legislation for pharmaceuticals implies an important role for gummed paper tape

Packaging and closing tapes play a dominant role in meeting two major legal provisions for the European pharmaceutical industry: The Falsified Medicines Directive (2011/62/EU) and its derived Commission Delegated Regulation (EU) 2016/161, published this February. Especially gummed paper tape is a major contributer to fulfill the requirements.

These legal provisions supply details on how the authenticity of medicines should be verified and by whom, as well as the characteristics of the safety features. The deadline for pharmaceutical packaging compliance with the Falsified Medicines Directive is 9 February 2019 in the majority of EU member states.

A major element includes that tamper-proof sealed packaging must be used to prevent falsified medicinal products entering the legal supply chain. An estimated 30 billion medicinal packs are sold and handled annually in Europe.

Anti-tampering device has to enable verification of package tampering. CEN standard EN 16679/2014: “Tamper verification features for medicinal product packaging”, serves to define the features used for tamper verification. These features should indicate that the outer packaging of a finished product has been opened or tampered with in order to prevent the unnoticed entry of falsified medicines into the legal supply chain.

The information provided by this standard primarily serves as guidance to pharmaceutical manufacturers and relevant approval and test institutes with respect to testing the suitability of seals, and lays down the following requirements:

  • The tamper-proof seal must not impair the readability of the prescribed information
  • The prescribed packaging text must remain readable after the pack has been opened
  • The application of features to check tampering attempts may lead to an increase of the physical force required to open the packaging but must not substantially aggravate handling and opening the pack
  • The utilization of opening aids, such as special perforations or starter tabs, may be necessary.

In fact, the standard describes the scope of application, the requirements and features of tamper-proof pharmaceutical packaging, and provides specific recommendations for appropriate sealing. Gummed paper tape is the appropriate sealing method to support these requirements.

NL Hoofddorp 2017 May 15