On 13 April 2005, the European Commission issued the document "Guidance
concerning the Braille requirements for labelling and the package leaflet".
According to this guidance, all medicinal products for which a marketing
authorisation is issued after 30 October 2005 must have Braille on the
package.
For the technical implementation of these requirements, the European
Carton Makers Association (ECMA) published the recommendations "Braille
on Folding Cartons". They deal with subjects like standardisation,
technical requirements, production or the positioning of the Braille text
on the folding carton. Thus, the correct and complete use of Braille now
has to be checked also in production at the printing works and during
incoming goods inspection at the pharmaceutical manufacturer's site. For
this purpose, a number of systems enabling the automated control of Braille
texts have been developed. Among them are:
- Braille Compare (Ladegast Pharma Packaging)
- Pharma Print Control (Krauss Software GmbH)
- Pixel Proof (Gradient System Integration)
- Text Verification Tool (Schlafender Hase)
The guidance by the European Commission and ECMA's recommendations can
be downloaded here:
|
