In 2004 the European Commission has issued the Council Directive 2004/27/EC – amending Directive 2001/83/EC - that requires Braille labelling on outer packaging for medicinal products within the European Union. In practice it means that the name of the medicinal product and if need be the strength and the form has to be labelled in Braille on the outer packaging. This is usually done by embossing the Braille on a folding carton or by applying a Braille label. The EU-Directive had to be transposed into national law by all member countries in the European Union. Depending on the national law of the referring EU member country the majority of folding cartons for medicinal products has to be labelled with Braille.
In compliance with these 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 in September 2005.
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.
Through some of its member companies and national associations ECMA has participated in the creation of a European standard EN 15823 “Braille on packaging for medicinal products” at the European committee for standardization CEN. During the discussion and the creation of this standard, ECMA has provided position papers on major subjects in May 2006 and in September 2008. Basic contents of the ECMA guidelines “Braille on folding cartons” and the ECMA position papers referring to “Braille on packaging” have been incorporated into the European Standard EN 15823 “Braille on packaging for medicinal products”.
EN 15823 has been published as European standard in October 2010 and since is valid as a national standard in the 32 national standards bodies that are members of CEN. It can be derived as download or as paper copy from the websites of the national standards bodies.
Since outside of the EU the demand for Braille labelling on packaging has increased and in order to achieve an international technical standardisation the existing EN 15823 “Braille on packaging for medicinal products” is currently transferred into an International standard at the International organisation for standardization ISO. ISO DIS 17351 “Braille on packaging for medicinal products” will generally have the same contents as EN 15823 and so will safeguard an internationally standardized way of applying Braille on packaging for medicinal products”.
The ECMA guidelines “Braille on folding cartons” and the ECMA position papers published May 2006 and September 2008 can be downloaded from the ECMA Website or can be derived from the ECMA Secretariat: mail@ecma.org.
