BS EN 16679:2014 - Packaging. Tamper verification features for medicinal product packaging

BS EN 16679:2014

Packaging. Tamper verification features for medicinal product packaging

Status : Current   Published : December 2014



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.

Standard NumberBS EN 16679:2014
TitlePackaging. Tamper verification features for medicinal product packaging
Publication Date31 December 2014
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)2011/62/EU, 2001/83/EC, EN ISO 9000:2005, 21CFR211.132
International RelationshipsEN 16679:2014
Draft Superseded By14/30288557 DC
DescriptorsPackaging, Verification, Drugs, Products, Drug administration
Title in FrenchEmballage. Témoins d'effraction pour emballages de médicaments
Title in GermanVerpackung. Merkmale zur Überprüfung von Manipulationen an Arzneimittelverpackungen
ISBN978 0 580 84024 1
File Size1.078 MB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version

Worldwide Standards
We can source any standard from anywhere in the world

Collaborate, Innovate, Accelerate.