Since 30 October 2010 all medicines now have the name of the medicine displayed in Braille on the labelling. In addition the patient information leaflet must be supplied in a format suitable for blind and partially sighted patients. The legislative provisions are set out in Article 56(a) of Council Directive 2001/83/EC (as amended).

• Braille generator

• Braille certification

Under article 56(a) of Council Directive 2001/83/EC [as amended] there is a legal obligation on all marketing authorisation holders to make available the statutory patient information in a format suitable for the patient at their request.

Guidance concerning the Braille requirements for labelling and the package leaflet

For more information please contact us at: enquiries@pharmafile.ie