BS EN 16679:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Packaging. Tamper verification features for medicinal product packaging
Hardcopy , PDF
26-10-2020
English
31-12-2014
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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.
| Committee |
PKW/0/-/5
|
| DevelopmentNote |
Supersedes 14/30288557 DC. (01/2015)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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.
| 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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