CEN/TC 261/SC 5/WG 12 - Marking
The work of WG 12 is restricted to markings concerned with all aspects of handling package. This working group is responsible inter-alia for the implementation of ISO 780 as an European standard.
Marking
The work of WG 12 is restricted to markings concerned with all aspects of handling package. This working group is responsible inter-alia for the implementation of ISO 780 as an European standard.
General Information
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.
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This European Standard specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.
NOTE 1 The labelling of medicinal products placed on the market and incorporating Braille in accordance with this European Standard meets the requirements of European Directive 2001/83/EC, Article 56, (a) as amended by Directive 2004/27/EC [1].
NOTE 2 The principles in this European Standard can be applied in other sectors, as appropriate.
- Standard18 pagesEnglish languagesale 10% offe-Library read for1 day