EN 16679:2014

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

Publication date:   Apr 21, 2015

General information

99.60 Withdrawal effective   Oct 14, 2020

CEN

CEN/TC 261 Packaging

European Norm

03.120.10   Quality management and quality assurance | 11.120.10   Medicaments | 55.020   Packaging and distribution of goods in general

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Scope

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.

Life cycle

NOW

WITHDRAWN
EN 16679:2014
99.60 Withdrawal effective
Oct 14, 2020

REVISED BY

PUBLISHED
EN ISO 21976:2020