Packaging. Braille and other formats for medicinal products
Packaging. Braille and other formats for medicinal products
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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...
Другие стандарты DD