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DIN EN 16679

2015 Edition, March 1, 2015

Complete Document

Packaging - Tamper verification features for medicinal product packaging

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Active, Most Current

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Product Details:

  • Revision: 2015 Edition, March 1, 2015
  • Published Date: March 2015
  • Status: Active, Most Current
  • Document Language: English
  • Published By: Deutsches Institut fur Normung E.V. (DIN)
  • Page Count: 20
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

This European Standard specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

NOTE The packaging of medicinal products placed on the market and incorporating tamper verification features in accordance with this European Standard meets the requirements of Directive 2001/83/EC as amended by Directive 2011/62/EU. Article 54(o) of the Directive stipulates, that on the outer packaging of certain medicinal products or, where there is no outer packaging, on the immediate packaging shall appear, among others, "a device allowing verification of whether the outer packaging has been tampered with".

The principles in this European Standard can be applied in other countries and sectors, as appropriate.