When the document comes into operation it will supersede the current guidelines that have been in force since 1998 and offer numerous new recommendations to packaging manufacturers.
The new guidance incorporates a number of articles that were laid out in Directive 2001/83/EC, which includes an expansion on the guidance for creating labels and leaflets for blind and partially-sighted patients.
Included in this are details on how to use Braille in a manner that ensures the leaflet is legible to blind and partially sighted patients. This encourages the standardisation of Braille used on pharmaceutical packaging and what information needs to be covered.
Braille does not have to be put onto primary packaging, for instance blisters or ampoules, but should appear on the outer packaging. It is recommended that this is not done with an adhesive label to negate the risk of affixing the wrong label to a package.
Product name and strength are the two details that the EC recommends should be put onto labelling although other details can be added when space permits.
The issue of space also impacts upon how Braille is applied to small volume packages, which are defined as less than 10ml. For these packages the EC permits the use of contracted Braille or certain defined abbreviations, which it says should not be used when more space is available.
A copy of the complete document, which covers other alterations to the guidelines, can be found here .
