The legal necessity to emboss the denomination of the drug in Braille on folding cartons is determined by the European drug legislation (guideline 2001/83/EC-human codex). This provision has to be transferred into national law by all member countries of the European Union. In Germany, this has already been accomplished by the German drug law (ยง10 paragraph 1b AMG). Directive 2001/83/EC as amended by Directive 2004/27/EC, Article 56 a Directive 2001/83/EC as amended by Directive 2004/27/EC, Article54 a DIN EN 15823 : 2010 This European Standard specifies requirements and provides guidance for the application of Braille for the labelling of medicinal products. In the first place it is focussed on supporting the implementation of Braille on medicinal products available in the European Union (EU) and in the European Economic Area (EEA). On the European level Working Group CEN/TC 261/SC 5/WG 12 "Marking" is responsible for the works. The secretariat of this Working Group is held by Packaging Standards Committee (NAVp) of DIN. The work was accompanied by German Mirror Committee NA 115-01-03 AA "Markierung" ("Marking"). Please use our contact form to find out, how you will be able to fulfill this new European standard with our Braille inspection products. |