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
Frequently Asked Questions
CEN/TC 261/SC 5/WG 12 is a Subcommittee within the European Committee for Standardization (CEN). It is named "Marking" and is responsible for: 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. This committee has published 2 standards.
CEN/TC 261/SC 5/WG 12 develops CEN standards. The scope of work includes: 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. Currently, there are 2 published standards from this subcommittee.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Subcommittee (SC) in CEN operates under a Technical Committee and focuses on a specific subset of the TC's scope. Subcommittees develop standards and technical specifications in their specialized area, reporting to their parent Technical Committee. They may also have working groups for detailed technical work.
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.
- Standard18 pagesEnglish languagee-Library read for1 day
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 languagee-Library read for1 day