In accordance with EU Directive 2004/27/EC – amending Directive 2001/83/EC (community code to medicinal products for human use), on pharmaceutical cartons the name of the medicinal products - and if need be the strength - must be expressed in Braille format. The Directive has to be transposed into national law by all member countries in the European Union by 30 October 2005.
In compliance with the new legal requirements, on the initiative of national associations and pharma carton specialists represented on the ECMA Pharma Forum, ECMA has launched a European code of practice for the production of Braille on folding cartons.
This code of practice contains established rules which form an easily-comprehensible standard for the technical implementation of Braille on folding cartons, as well as offering guidelines for a sequence of steps from the creation of the artwork files to the delivery of the folding cartons to ensure the integrity and security of the Braille content. To establish a common standard across the countries of the European Union, the standard specifies “ECMA Euro Braille”, which takes account of the major Braille fonts currently in use throughout Europe.
Also included in the booklet is a reference list containing the Braille letters, numbers and internationally standardised special characters, as well as the relevant special Braille characters for six of the main languages in the EU.
To download the document, click here or order a hard copy of the booklet (free of charge) at the ECMA Secretariat.