The movement towards universal inclusion of Braille on pharmaceutical packaging in Europe and North America is clearly under way. From October 2005, the 25 member states of the European Union are required to have legislation in place in conformance with the EU Directive 2001/83/EC: this requires that all products authorised after October 30 2005 carry Braille identification. In May 2009 the International Association of Diecutting and Diemaking (IADD) announced “Can-Am Braille,” a set of guidelines and recommendations for the use of braille on packaging in USA and Canada.
What does the EU Directive say?
Council Directive 2004/27/EC – Article 56(a)
“The name of the product, as referred to in Article 54, point (a) must also be expressed in braille format on the packaging. The MA holder shall ensure that the packaging information leaflet is made available on request from patients’ organisations in formats appropriate for the blind and partially sighted”
The pharmaceutical directive applies to all medicinal products for human use intended to be place on the markets in the EU Member States. All EU legislation relating to pharmaceutical products is covered under the EEA Agreement and so the EEA areas (Iceland, Liechtenstein and Norway) must also implement this directive.
When did the legislation come into force?
European requirements have affected all products that were granted marketing authorization from 30 October 2005 onwards. Medicines that had marketing authorisation prior to this date were required to comply by 30 October 2010.