SS-EN-16679 Packaging - Tamper verification features for medicinal product packaging

SS-EN-16679 - 2014 EDITION - CURRENT


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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.

To find similar documents by classification:

03.120.10 (Quality management and quality assurance)

11.120.10 (Medicaments Including medical prescriptions and medicinal herbs)

55.020 (Packaging and distribution of goods in general)

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Designation Name

SS-EN 16679:2014

Revision Level

2014 EDITION

Status

Current

Publication Date

Dec. 21, 2014

Language(s)

English

Page Count

28

International Equivalent

EN 16679:2014(IDT)