Accessible Pharmaceutical Labelling
In compliance with European Directive 2004/27/EC - Article 56(a), all medicine sold in the European Union must have the product name in braille on the packaging. Likewise, the patient information leaflet (found inside the medicine package) must be made available in alternative formats.
Update (March 2010)
The European Blind Union has worked across its member states and with the pharmaceutical and packaging industries, alongside its involvement with the CEN standard development for braille on packaging and leaflets, and has developed a range of information to help the industry to comply with EU Directive 2004/27/EC.
- After more than 4 years of deliberation and negotiation, we expect that during 2010 a European standard will be adopted for braille on medicinal packing. This means that the industries involved will have more specified values and procedures to follow when providing information in braille on the outer packaging. This will include the name, strength and in some cases, the form of the medicine.
- Another outcome of the standardization process is a piece of scientific research undertaken by the University of Birmingham (UK) and sponsored by blindness agencies and the pharma-packaging industry. The findings contributed to the requirements included in the standard. The research investigates the correlation between the height of braille dots and the readability of the information by braille users. The dependence between the height of dots and the degree of security with which the braille user could identify the product is described in a robust and useful way, as is the effect of braille on the readability of underlying printed information for sighted people.
The full research report is available online in two formats:
- Word, at www.education2.bham.ac.uk/documents/research/VICTAR/Braille_Height.doc
- PDF, at www.education2.bham.ac.uk/documents/research/VICTAR/Braille_Height.pdf
- Another outcome of the standardization work also worth noting is the establishment of a braille symbol database available on a website created and hosted by RNIB (Royal National Institute of Blind People) on behalf of EBU. This website contains a wealth of useful information about braille of primary relevance for the pharmaceutical industry. They need the information to ensure that the signs placed on the packs are correct, and hence useful for the full intelligibility of the information in all European countries.
The database includes an EBU recommended braille character set and a list of countries who have agreed to use it for pharmaceutical packaging, together with EBU guidance for presenting common abbreviations, numbers and so on. Furthermore, as these guidelines are not mandatory for the member countries, the specific literary braille code in the various European countries can also be found in the database. All of the tables and the braille information on this website are given in graphical formats but also in formats that are fully accessible for braille readers/users with a visual impairment.
The website can be found at http://ebu.rnib.org.uk Through an annual subscription fee, organizations gain access to crucial information to make the braille on medicine packaging fully useable in your country. Free subscriptions are available to non-profit organizations in the voluntary sector including organizations of and for the blind, blindness agencies and braille authorities.
Blindness agencies: The tables are not fully complete due to a lack of full responses from a number of countries. For this reason, we are urging all the braille authorities or organizations of the blind in each country firstly to check the website for the EBU recommended code, guidelines, their own country codes, and their position on acceptance of the EBU code and guidelines, and to notify us of amendments. Secondly, to help us keep the database up-to-date, we would value your help by checking the database on an ongoing basis, e.g. every six months, and informing us of any changes in your national braille code. In both cases, please notify us by email at firstname.lastname@example.org.
Pharmaceutical companies: If you have questions about the presentation of braille which are not yet addressed by the EBU guidance, please email us with examples, and we'll do our best to provide guidance through consultation with our experts, and update the guidance with similar examples. Please email us at email@example.com.
We aim to have the most updated information across Europe on existing literary braille as possible. Updates will be notified to all registered users of the site, and each page will specify the date of the last update.
Other useful information