A standard for Pharmaceutical Packaging Braille was recently completed and adopted by the European Standards Organisation (CEN) and is now available in the UK as British Standard BS EN 15823:2010 entitled “Packaging – Braille on Packaging for Medicinal Products”.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

This European Standard is the result of a number of years of work by a CEN Working Group encompassing organisations for the visually impaired, health agencies, the pharmaceutical industry, and packaging and materials suppliers. It specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.

Braille Dot Height

Of particular note, the new standard sets out the basic physical parameters for the height of Braille dots on pharmaceutical packaging:

“For embossed materials the target Braille cell dot height shall be 0,20mm… “

The recommendation for Braille dot height was arrived at following the results of research at University of Brimingham into the effect of dot elevation on the legibility of Braille on pharmaceutical products. The document also gives details of methods for the measurement of Braille dot height to ensure that legibility is validated.

Contains Pharmaceutical Braille Guidance and Information

A significant amount of information can also be found in the publication, providing guidance on Braille for pharmaceutical packaging and its application. This is contained in a number of annexes to the document. These include Braille characteristics, technology for the application of Braille to pharmaceutical packaging, artwork generation, Marburg Medium Standard and Braille character sets.

It is hoped that the development of the standard will enable manufacturers to rationalise across Europe their approach to the fulfilment of the requirement of the medicines legislation to apply Braille to all packs of medicinal products.

BS EN 15823:2010 “Packaging. Braille on packaging for medicinal products” may be purchased online from the BSI Shop

After more than 4 years of deliberation and negotiation the European Blind Union expect that during 2010 a European standard, EBU Pharmaceutical Braille, will be adopted for braille on medicinal packaging. This means that the industries involved in producing pharmaceutical packaging will have more specific values and procedures to follow when providing information in braille.

The standard follows the spacing specifications of Marburg Medium and provides a single Braille character set for pharmaceutical labelling in Europe.

So, should we begin to use EBU Braille now? Well… it is a little confusing…

European Braille authorities were asked whether they would agree to follow the EBU guidance proposed. Unfortunately, only a few have agreed to accept the standard. Currently, the countries where EBU Braille is acceptable are:

• Austria
• Denmark
• Iceland
• Ireland
• Italy
• Netherlands
• Norway
• Portugal
• Sweden
• UK

Some countries are still considering.

So far, France, Poland, Romania, Slovakia and Slovenia have rejected the EBU standard. Which is a real disappointment for all in the pharmaceutical packaging industry.

Most pharmaceutical products are distributed in more than one country. At the moment the Braille characters for the letters A-Z and the numbers 0-9 (with the exception of France) are the same throughout Europe. However, each country’s Braille authority has often differing specifications for accented characters, symbols and punctuation. To be more cost effective and to reduce the possibility of making errors in Braille for pharmaceutical packaging the packaging industry would benefit from being able to use just one Braille code across the European Union. With that ultimate goal in mind the European Blind Union has issued a proposal for a standard E.U. Pharmaceutical Braille Table.

The EBU carried out a review of the Braille codes across the EU and have come up with proposals to achieve a single Braille character set for pharmaceutical labelling. Their proposed guidelines provide definitive answers to the many frequently asked questions we receive here at PharmaBraille about how Braille code should be implemented, such as spacing, abbreviations, capitalisation and fitting Braille on the pack.

We at PharmaBraille welcome the progress made to develop a standard for Pharmaceutical Braille and have already started work on a European Pharmaceutical Braille Standard font set. 

About the European Blind Union

The European Blind Union is a non-governmental, non profit making European organisation founded in 1984. It is one of the six regional bodies of the World Blind Union, and it promotes the interests of blind people and people with low vision in Europe.

It currently operates within a network of 45 national members including organisations from all 27 European Union member states, candidate nations and other major countries in geographical Europe.

The IADD working in conjunction with the Braille Authority of North America (BANA) officially released the Can-Am Braille standard on Friday, May 8, at the 2009 IADD•FSEA Odyssey in Atlanta, GA, USA. An informative technical workshop, “Let Your Fingers Do The Talking: Braille on Folding Cartons” reviewed the “North American standard in detail. All participants received a copy of the North American Braille on folded cartons standard.

“The use of braille in packaging will continue to increase over the next several years,” predicts Stephen Brighton, IADD Braille Task Force Chair, “following European pharmaceutical and food product packaging trends in Europe.”

To better satisfy the needs of the visually impaired in North America, the International Association of Diecutting and Diemaking (IADD) has created “Can-Am Braille,” a set of guidelines and recommendations for the use of Braille on pharmaceutical packaging.

The IADD worked in conjunction with the Braille Authority of North America (BANA) over the past 18 months to develop the standard. Officially set for release on Friday, May 8, at the 2009 IADDFSEA Odyssey Show in Atlanta Can-Am Braille has been reviewed and received its final approval by the IADD Executive Committee and Board of Directors in January 2009.

“The use of braille in packaging will continue to increase over the next several years,” predicts Stephen Brighton, IADD Braille Task Force Chair, “following European pharmaceutical and food product packaging trends in Europe.” Manufacturers in Canada and the US are “already being told to meet European standards” to be able to supply to Europe. This increasing influence over the past few years has affected converters and toolmakers. Braille labeling means they have “had to go through a learning curve” to meet demands.

“Some pharma companies are requesting adherence to the ECMA Euro Braille standard (Marburg Medium) and others are allowing variations to exist because the cartons aren’t going into countries that fall under the EU regulations. As a toolmaker, we have seen braille being placed anywhere on the carton panels with a variety of dot diameters, dot spacing, character spacing, and line spacing.”

“It only makes sense that a uniform method for consistency is to be used,” he says. He underlines the importance it means to the IADD and BANA that companies achieve consistency to benefit the visually impaired.

So, developing the “Can-Am Braille” guidelines for pharmaceutical cartons was a logical step. Brighton said the standard would help ensure firms in North America and Europe “follow similar guidelines.” He continued, “From a North American perspective, it’s got to be done on a voluntary, pro-active basis before government gets involved.”

When asked why the IADD chose to base its standard on a European one, Brighton elaborates, “There is nothing about Braille that we can hold autonomous. We have had the opportunity to collaborate with BANA to marry their knowledge of Braille with our knowledge of what’s practically possible when applying Braille to paperboard substrates. What we are really dealing with is the independence of the visually impaired. Our responsibility is to ensure that their independence is respected and that we, as an industry, do the best that we can to produce pharmaceutical, fast food or other types of paperboard packaging with the best quality Braille for readability and continuity through the use of the standard. Otherwise the purpose of producing the Braille and the resources it takes in these economic times ends up being an exercise in futility for everyone involved.”

“We are looking forward to the implementation of this standard.” said Judy Dixon, chair of the Braille Authority of North America, “It will have the effect of making more Braille labels to help blind people identify the packages in their everyday lives and this will be a very positive step forward.”

Interestingly, no government legislation similar to that of Europe is currently proposed in the U.S. or Canada that would require pharmaceutical packaging to have Braille on it. The original concept of creating a North American standard stemmed from a Braille workshop and discussions at an IADD Can-Am Chapter meeting. Some members had participated in a braille workshop at the IADD Annual Meeting in Switzerland in November 2006. 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. This has allowed the standard to be developed in a time frame that fosters continuity, making it more of an international standard, and that ensures it will work from a practical standpoint.

PharmaBraille Can-Am Braille is now available from PharmaBraille. The font sets follow the Braille characters set by the Braille Authority of North America and incorporate changes to the European standard requested by BANA.