Pharmaceutical Artwork Braille –
from Pharma Design

Pharmaceutical artworks & packaging design –
Specialists in providing pharmaceutical packaging artworks for the pharmaceutical, biotech and healthcare industry

Pharmaceutical artwork outsourcing

Pharma Braille requirements for pharmaceutical labelling

From 30 October 2005 new requirements for Braille to appear on the labelling and in the patient information leaflet of all medicines were introduced under Article 56(a) of Council Directive 2001/83/EC (as amended).

Implementation of Braille in pharmaceutical artwork files

We have been creating pharmaceutical artworks long before Braille and Braille requirments were first introduced which means our pharma clients benefit from our experience including multi language Braille implementation.

As part of our Quality Assurance at Pharma Design, we implement the generation and application of Braille to recommended printing criteria and industry legislations:

The Braille is applied to a separate layer in the artwork file. The specific colour used to represent the Braille text is not used in any other place in the document. The Braille statement is also translated, reproduced in regular type outside the line of the embossing die for visual verification (as demonstrated in the above diagram).

The Braille fonts we use comply with the Marburg Medium specification, which has been recommended by the European Commission for use on pharmaceutical packaging and labels. The Marburg Medium font specification means the fonts are set to a font size of 10mm and the leading (line spacing) is also set to 10mm. This is the absolute required size at 100% and cannot be scaled due to the Braille letter (size of Braille cell) standard.

External Braille links and resources

• European Commission - Article 56(a) of Council Directive 2001/83/EC (as amended) [external PDF]
• RNIB - Pharmaceutical Braille Help [external link]
• MHRA - Braille on labelling and in patient information leaflet of all medicines [external PDF]
• ECMA - Braille on Folding Cartons [external link]
• European Blind Union (EBU) - Accessible Pharmaceutical Labelling [external link]
• Tiresias - Braille Labelling of Medicines [external link]

If you require help with compliant and multi language Braille application, please contact us today on: +44 (0)1428 656 656 or email us and find out how we can help.