EU Requirements on Braille for Printed Packaging Materials

GMP News No. 727

GMP News
12 May 2006

EU Requirements on Braille for Printed Packaging Materials

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:

The GMP Education Course "Printed Packaging Materials" in Basle on 26-27 June presents you with a number of these automated text control systems. Users from the pharmaceutical industry share their experiences gained in daily practice. Which are the advantages and disadvantages of the individual systems? One of the lectures deals in detail with Braille, from the European requirements to the automated control. The programme is rounded off by a visit to a printing works for pharmaceutical packaging materials.
Dr Günter Brendelberger
On behalf of the European Compliance Academy

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