Braille

Provision on the labelling in formats suitable for blind and partially sighted patients

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).

SEQ can help you to meet the specific recommendations for blind and partially sighted patients for Braille on product packaging as required:

  • Braille generator.

  • Braille certification.

Please note:
Provision of the PIL in formats suitable for blind and partially sighted patients.
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 (external link)

For more information please contact us at: enquiries@nerin.co.im