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BS EN 16679:2014

BS EN 16679:2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Packaging. Tamper verification features for medicinal product packaging

Available format(s)

Hardcopy , PDF

Superseded date

10-26-2020

Language(s)

English

Published date

12-31-2014

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements
4 Categories of tamper verification features
Annex A (informative) - Additional information
        regarding tamper verification features
Bibliography

Defines requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

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.

Committee
PKW/0/-/5
DevelopmentNote
Supersedes 14/30288557 DC. (01/2015)
DocumentType
Standard
Pages
22
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 16679:2014 Identical

CFR 21(PTS200-299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)

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Hardcopy - English
PDF - English
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