What does the 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 Member States. All EU legislation relating to pharmaceutical products is covered under the EEA Agreement and so the EEA areas (Iceland, Liechtenstein and Norway) will also be implementing this directive.
The EU has recommended a Braille specification referred to as “Marburg Medium“. The specification sets out the Braille cell dimensions, spacing and dot size. It can NOT be varied in size in any way. Grade 1 (uncontracted) Braille is recommended to be used on all packaging to enable the greatest number of people to read it.