The requirement is in Article 56a of Directive 2001/83/EC. It applies to the name of the medicine on the outer packaging, and marketing authorization holders also have to make the package leaflet available in formats suitable for blind and partially sighted patients on request. Details such as dot dimensions and spacing are set out in the European Commission's guideline on packaging information. The Braille is usually embossed into the carton during printing and finishing.
Why it matters for labeling
Braille is part of the artwork and also a physical feature, so it has to be right in two ways: the Braille text has to match the approved product name exactly, in every market and language variant, and the embossing has to meet the dimensions and position specified. A product with several strengths or presentations may need different Braille on each. A difference between the printed name and the Braille is easy to miss, because few reviewers can read it.
Common mistakes
- Braille text that doesn't match the printed product name
- Braille missing from some market or strength variants
- Dot size or spacing out of specification after embossing
- Artwork changes that move or overlap the embossing area