DD 264:2007

DRAFT FOR DEVELOPMENT

DD 264:2007 Packaging. Braille and other formats for medicinal products

DD 264:2007 is a Draft for Development (DD) that specifies the requirements and provides guidance for the application of Braille to the labelling of medicinal products.

The provision of information on medicinal products in alternative formats, suitable for blind and partially-sighted people, is also addressed.

The labelling of medicinal products (and associated package information leaflet; see Annexes A and B) placed on the market and incorporating Braille in accordance with this Draft for Development meets the requirements of the UK implementation [4] [5], of the European Directive 2001/83/EC Article 56 (a) as amended by Directive 2004/27/EC [1].

The general principles in DD264 Draft for Development can be applied in other sectors, as appropriate.

Contents of DD 264:2007 includes:

• Foreword
• Scope
• Terms and definitions
• General requirements for medicinal product packaging
• Product identification and legibility of labelling

Annexes

• Package leaflet alternative formats
• Alternative package leaflet formats, critical control points
• Braille characteristics and recommendations
• Braille critical control points
• Braille character sets
• Braille verification
• Technology for the application of Braille to packaging for medicinal products
• Braille specifications and artwork generation
• Bibliography

List of figures

• The Braille cell
• Braille text representation
• Marburg medium spacing convention for Braille
• Braille transposition of letters in common use
• Principle of embossing
• Example of Braille positioning on a carton
• Approved artwork proof
• List of tables
• Alternative package leaflet formats, critical control points
• Braille artwork/origination

DD 264, the Draft for Development was published by BSI and came into effect on 31 July 2007. It was prepared by Technical Committee PKW/0, Packaging. A list of organizations represented on this committee can be obtained on request to its secretary.

Information about this document

Council Directive 2004/27/EC [1] modifies the Community Legislation for medicinal products for human use (Council Directive 2001/83/EC [2]), and by incorporation into national legislation introduces the need to include on the outer packaging of authorized medicinal products their names in Braille as an aid to identification for blind and partially sighted people.

DD 264 is primarily aimed at supporting the implementation of Braille on medicinal products in the European Union (EU) and European Economic Area (EEA) and in particular Part 1 of the associated European Commission Braille Implementation Guidance [3]. In addition to Braille on the labelling of the package, it supports the requirement to provide the package leaflet in formats for blind and partially sighted people.