The movement towards universal inclusion of Braille on pharmaceutical packaging 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 carry Braille identification. 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 EU Member States. All EU legislation relating to pharmaceutical products is covered under the EEA Agreement and so the EEA areas (Iceland, Liechtenstein and Norway) must also implement this directive.
When did the legislation come into force?
European requirements have affected all products that were granted marketing authorisation from 30 October 2005 onwards. Medicines that had marketing authorisation prior to this date were required to 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 recommend that guidance is taken from the following sources:
- European Standard Developments – CEN. Standard EN 15823
- EBU European Braille Guidance
- International Association of Diecutting and Diemaking
- Local braille authorities for the countries you distribute in. The International Blindness Agencies Directory can help to identify Braille organisations for each country.
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. It is important that the Braille is confirmed by the local Braille authority.
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 a single pass process. 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 process).
- Screen-printing: This process can be used on different substrates e.g. paper, carton board and polymers. The integration of Braille fonts onto packaging components is normally treated as an additional colour and printed using screen technology. The dots are usually transparent to not affect the legibility of the graphics and text underneath.
- Integral Braille: Containers may be manufactured incorporating Braille in their structure.
- Adhesive labels: Braille can be incorporated onto adhesive labels which are subsequently applied to packaging during the manufacture of the medicinal product. These can be produced by a variety of processes.
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.
- Letters and symbols must be formed in Braille according to the national standard in the country / countries where the product is marketed.
- Trademark symbols should be omitted unless required for legal purposes.
Note: While every care has been taken to check the accuracy of the symbols used in each language, we cannot guarantee the accuracy of this information. Please confirm Braille character sets with the relevant local Braille authority. The International Blindness Agencies Directory can help to identify Braille organisations for each country.