Historical

DIN EN 16679:2015

Packaging - Tamper verification features for medicinal product packaging; German version EN 16679:2014


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 1: 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 packaging has been tampered with".The principles in this European Standard can be applied in other countries and sectors, as appropriate.


CONTENT PROVIDER
Deutsches Institut für Normung [din]

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Document History
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