Legal regulations

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 (§10 paragraph 1b AMG).

Directive 2001/83/EC as amended by Directive 2004/27/EC, Article 56 a
The name of the medicinal product, as referred to in Article 54 a must also be expressed in Braille format on the packaging. The marketing authorization holder shall ensure that the package information leaflet is made available on request from patients organisations in formats appropriate for the blind and partially-sighted.

Directive 2001/83/EC as amended by Directive 2004/27/EC, Article54 a
The name of the medicinal product, followed by its strength and pharmaceutical form, and if appropriate, whether it is intended for babies, children or adults; where the product contains up to three active substances, the international non-proprietary name (INN) shall be included, or, if one does not exist, the common name.

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").

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