August 03,2009
DEADLINE FOR BRAILLE REQUIREMENTS AND UPDATING OF LEAFLETS AND LABELS TO QRD FORMAT.

Braille Requirements:

Title V of the Council Directive 2001/83/EC requires Marketing Authorisation Holders to emboss Braille product information on the outer packaging of the medicinal product. The deadline for implementation of this requirement is October 2010.  Products which are for administration by healthcare professionals only are excluded. Furthermore applicants must meet the requirement to provide the leaflet in a format suitable for people who are blind or partially sighted for all medicinal products by that date. The IMB are encouraging applicants to submit Braille Declarations and associated labelling for any remaining products before April 2010 to ensure the deadline can be met after the usual six month implementation time.

Requirements for Package Labelling and Patient Information Leaflets

Marketing Authorisation Holders are reminded that all authorisations must be in line with the labelling and leaflet requirements in Title V of the Directive by October 2010.  The QRD templates provided in all EEA languages on the EMEA Website provide detailed guidance on how to complete each section of the Patient Information Leaflet and Labels so that they are in compliance with these requirements. The IMB have requested that applications to update the package labelling and patient information leaflets in line with the requirements must be submitted before April 2010.