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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Packaging. Tamper verification features for medicinal product packaging

    Available format(s):  Hardcopy, PDF

    Superseded date:  26-10-2020

    Language(s):  English

    Published date:  31-12-2014

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

    Scope - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee PKW/0/-/5
    Development Note Supersedes 14/30288557 DC. (01/2015)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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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