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BS EN 16679:2014

BS EN 16679:2014

$102.76

Packaging. Tamper verification features for medicinal product packaging

Published By Publication Date Number of Pages
BSI 2014 22
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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.

PDF Catalog

PDF Pages PDF Title
4 Contents Page
6 Foreword
7 Introduction
8 1 Scope
2 Terms and definitions
9 3 General requirements
3.1 Tamper verification features
3.2 Purpose of tamper verification features
3.3 Application and use of tamper verification features
3.4 Check of tamper verification features
10 4 Categories of tamper verification features
4.1 General
4.2 Folding boxes closed with glue
4.2.1 Description
4.2.2 Criteria of tamper verification
4.2.3 Verification
11 4.3 Specially constructed folding boxes
4.3.1 Description
4.3.2 Criteria of tamper verification
12 4.3.3 Verification
4.4 Sealing labels and tapes
4.4.1 Description
4.4.2 Criteria of tamper verification
4.4.3 Verification
13 4.5 Film wrappers
4.5.1 Description
4.5.2 Criteria of tamper verification
4.5.3 Verification
14 4.6 Sleeves
4.6.1 Description
4.6.2 Criteria of tamper verification
4.6.3 Verification
4.7 Breakable or tear-away closure
4.7.1 Description
15 4.7.2 Criteria of tamper verification
4.7.3 Verification
4.8 Display blister pack
4.8.1 Description
4.8.2 Criteria of tamper verification
16 4.8.3 Verification
4.9 Flexible packaging
4.9.1 Description
4.9.2 Criteria of tamper verification
4.9.3 Verification
17 4.10 Blow-fill-and-seal-container (BFS)
4.10.1 Description
4.10.2 Criteria of tamper verification
4.10.3 Verification
18 4.11 New and emerging technologies
19 Annex A (informative) Additional information regarding tamper verification features
20 Bibliography

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BS EN 16679:2014
$102.76