Pharmaceutical Braille

The movement towards Braille on Pharmaceutical Packs in Europe and North America is clearly under way. From October 2005, the 25 member states of the European Union are required to have legislation in place in conformance with the EU Directive 2001/83/EC: this requires that all products authorised after October 30 2005 need to carry Braille identification and specifies the deadline by which all existing products must carry Braille. In May 2009 the International Association of Diecutting and Diemaking (IADD) announced “Can-Am Braille,” a set of guidelines and recommendations for the use of braille on packaging in USA and Canada.

What does the EU Directive say?

Council Directive 2004/27/EC - Article 56(a)

"The name of the product, as referred to in Article 54, point (a) must also be expressed in braille format on the packaging. The MA holder shall ensure that the packaging information leaflet is made available on request from patients' organisations in formats appropriate for the blind and partially sighted"

The pharmaceutical directive applies to all medicinal products for human use intended to be place on the markets in the Member States. All EU legislation relating to pharmaceutical products is covered under the EEA Agreement and so the EEA areas (Iceland, Liechtenstein and Norway) will also be implementing this directive.

When does the legislation come in?

European requirements have affected all products that were granted marketing authorisation from 30 October 2005 onwards. For medicines that had marketing authorisation prior to this date, the transitional period in the European Union runs for 5 years. All marketing authorisations must therefore comply by 30 October 2010.

In North America Can-Am Braille is a voluntary standard. There is currently no legislation covering Pharmaceutical Braille. It was felt that a proactive approach on the part of industry to develop and implement its own standard would be a way of reducing or even eliminating legislative intervention. The standard is very similar to the European Braille standard.

Are there any standards or guidance to refer to?

We would recommend that guidance is taken from the following sources:

What about producing braille on Pharmaceutical packaging across Europe and North America?

Each country has its own braille code. There are some commonalities but there are some important differences. This can cause difficulties in producing braille on packs that are distributed to more than one market. Although the Latin names may be the same across many markets this doesn't guarantee that the same braille can be used.

There will be differences between countries (as there would be for written languages such as French, German and English), but because some pharmaceutical names are similar across the EU and North America, discussions are taking place to see if a unified system of braille can be adopted for Pharmaceutical Braille.

Methods of brailling

There are several ways to provide the medicine package with the Braille labelling. The most common are:

  • Embossing: Embossing involves the use of a male die and a female die. The substrate for the carton or label is placed between two dies and a force is applied to create the Braille dots. During the production process it is common and economical to use tooling which both embosses the Braille and cuts/creases the substrate for the pack. This is single pass Braille. It is also possible to apply the Braille and cut/crease the substrate in separate operations using separate cut/crease and Braille tooling (two pass Braille).
  • Screen-printing: This process can be used on different substrates e.g.paper, carton board and polymers. The integration of Braille donts onto packaging components is normally treated as a colour and printed using screen technology. The dots are usually transparent. The applied dots should not affect the legibility of the graphics and text underneath.
  • Integral Braille: Containers may be manufactured incorporating Braille in their structure.
  • Adhesive labels: Braille con be incorporated onto adhesive labesl which are subsequently applied to packaging during the manufacture of the medicinal product. These can be produced by a variety of processes.

Braille specifications

Braille is a system where characters are represented as dots in a basic block two dots wide and three dots high called a Braille cell. All characters are combinations of dots within this framework.

For Pharmaceutical Braille the Marburg Medium Braille Specification is required.

Representation of characters

  • All names must be written in full (grade 1) Braille, meaning that no contractions are to be used.
  • Uppercase indicators are omitted.
  • The letters a-z are represented in Braille in the same way in all countries covered by the directive.
  • Accented characters have to be written in Braille according to the national standard in the country / countries in which such accented characters are parts of the alphabet.
  • Values given as numbers are to be given as follows: Number sign: dots 3456 (indicating that the next character(s) are interpreted as digits) followed by any or more of the letters a-j which will be interpreted as 1-0.
  • Trademark symbols should be omitted unless required for legal purposes.