BS EN 16679 for the Review of Manipulations on Medicinal Product Packaging issued

The norm BS EN 16679 from December 2014 with the title "Packaging - Tamper verification features for medicinal product packaging" has been available at British Standards since 31 December 2014.
This norm establishes requirements and provides instructions for the installation, use and testing of features for reviewing manipulations on medicinal product packaging. It supports the use and implementation of the counterfeit directive. This directive asks for security features for certain medicines to verify "authenticity and identification of individual packaging", as well as devices that will enable a control of the outer packaging for manipulations.

The norm 16679 handles the following types of pharmaceutical packaging: 

  • Folding cartons sealed with glue
  • Specially constructed folding cartons 
  • Sealing labels and tapes 
  • Film wrappers 
  • Sleeves
  • Breakage or tear-off closure
  • Display blister pack 
  • Flexible packaging 
  • BFS (blow-fill-and-seal) manufactured containers
  • New and emerging technologies 

At the British Standards website you can purchase the BS EN 16679 norm

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.