At various times over the last few years updates have been given in this column on the development by the European standards organisation (CEN) of a proposed standard for the Braille used on pharmaceutical packaging.
This standard has been of major interest to the industry and was eventually finalised and adopted earlier this year by CEN. It is now available in the UK as British Standard BS EN 15823:2010 – it can be purchased in the UK online from the BSI
The standard is the result of more than four years of intensive work by a CEN Working Group encompassing organisations for the visually impaired, health agencies and the pharmaceutical industry and its packaging and materials suppliers. It sets out the basic physical parameters for the height of Braille dots on pharmaceutical packaging that are accepted as demonstrating the legibility of Braille on such packaging. It also gives details of methods for the measurement of Braille dot height to verify this.
In addition to these normative requirements the standard also has a significant amount of informative content on Braille for pharmaceutical packaging and its application, and this is contained in a number of annexes to the document. These include Braille characteristics, technology for the application of Braille to pharmaceutical packaging, artwork and Braille character sets.
It is hoped that the development of the standard will enable manufacturers to rationalise across Europe their approach to the fulfilment of the requirement of the medicines legislation to apply Braille to all packs of medicinal products.
