Braille on labelling and in patient information leaflets: New provisions from 30 October 2005
Guidance on changes to labelling and patient information leaflets for self certification: Inclusion of Braille on the labelling Contact for further information
From 30 October 2005, new requirements for Braille to appear on the labelling and in the patient information leaflet of all medicines were introduced under Article 56(a) of Council Directive 2001/83/EC (as amended). We have produced the following questions and answers which are intended to provide additional helpful advice to applicants for marketing authorisations in relation to these new requirements:
Questions and answers to address issues of national application of the new provisions concerning Braille on labelling and in the patient information leaflet of all medicines.
This document is complementary to the following guidance issued by the European Commission and should be read in conjunction with it:
Guidance concerning the Braille requirements for labelling and the package leaflet (external link)
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. The differences are in the way the following symbols or units are described:
Whichever format is used, applicants should ensure that this is standardised across the range of medicines supplied.
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].
BS EN 15823:2010 - Packaging. Braille on packaging for medicinal products
Guidance on changes to labelling and patient information leaflets for self certification: Inclusion of Braille on the labelling
From 1 April 2009 compliance with article 56(a) of Council Directive 2001/83/EC may be achieved (in certain prescribed conditions) by means of a Better Regulation of Medicines Initiative (BROMI) notification to update the labelling on a marketing authorisation. Detailed guidance on how to prepare and submit a notification is announced. Enquiries should be directed to patient.information@mhra.gsi.gov.uk
Guidance on changes to labelling and patient information leaflets for self certification - compliance with article 56(a) - inclusion of Braille on the labelling
