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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).
Guidance is available in the Best Practice Guidance on the Labeling and Packaging of Medicines 2012 (133Kb) document and there is also guidance published by the European Commission to aid applicants.
The versions of Braille which the MHRA will accept on medicines labelling are set out in the two documents below. These are both approved by the Royal National Institute for the Blind and although there are minor differences in the two alphabets Braille readers in the UK will understand either system and MHRA assessors will accept either format.
Whichever format is used, applicants should ensure that this is standardised across the range of medicines supplied.
EBU Pharma - Braille site(external link)
The British Standards Institute has recently published BS EN 15823:2010 Packaging. Braille on the packaging of medicinal products. This specifies the requirements and provides guidance for the application of Braille to the labelling of medicinal products. Where compliance with this standard has been shown, such packaging will meet the regulatory provisions in article 56(a) of Council Directive 2001/83/EC [as amended].
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.
The MHRA has published separate guidance on this:
MAHs should ensure that they are clear about the exact requirements of individual patients and must provide the information requested in a timely manner.
Contact for further information
The Unit responds to and investigates enquiries and complaints regarding patient information reported by members of the public and the pharmaceutical industry. Enquiries and complaints should be made in writing and sent to: The Patient Information Quality Unit, MHRA, 151 Buckingham Palace Road, London SW1W 9SZ or email firstname.lastname@example.org