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With Braille becoming mandatory on folding cartons and labels for pharmaceutical use in most European countries, Sessions of York are utilising their expertise and knowledge in self-adhesive labels to surpass the new recommended Braille Standard and keep ahead of the competition.

Last year, EU Directive 2004/27 stated that information for the partially sighted and blind should be provided on medical products. This includes Braille on the packaging itself (under Article 56a). On the 30th October 2005, new EU directives relating to pharmaceutical labelling and packaging were implemented. The directives are Braille requirements on packaging and package leaflet and the user readability testing of the product information leaflet (PIL).

European pharmaceutical companies are already reporting that requests for Braille on packaging has significantly increased. Sessions of York, have reacted to this demand and have established a standard to meet their customers’ needs well before the Government passes these EU Directives. The EU’s recommendations for minimum dot heights hover between 0.46–0.50mm on cartons and 0.25mm for label printers, however, these are not viable on most high-speed packaging lines, machines and materials. An incorrect or missing dot would require a complete product recall, this incorrect dot would prove to be a very costly and damaging commercial exercise, so manufacturers are still very cautious.

However, Sessions of York have surpassed the EU’s 2004/27 directives and have achieved highly accurate 0.37mm - 0.4mm minimum dot heights on their label presses at high speeds. Sessions are printing on transparent filmic labels and the Braille dots are very precise. The safe use of medicinal products depends on partially sighted users accurately reading the labelling and packaging of the medicine and being able to understand the information provided. The purpose of providing large, clear and accurate information on pharmaceutical packaging and package leaflets is to reduce medication errors and Sessions of York are pioneering these labels.

Sessions ‘Profile’ Labels can provide a raised tactile image in Braille, Moon or large conventional lettering. Braille consists of a series of raised dots representing numbers and letters, allowing blind people to ‘read' by running their fingers over the text. Each Braille character or cell is made up of six dot positions in a rectangular shape comprising two columns of three dots each. A dot may be raised at any of the six positions and each combination of raised dots corresponds to a letter of the alphabet, a punctuation mark or another symbol.

The pharmaceutical industry is currently facing problems regarding the enforcement of the 2004/27 regulations, as thousands of new pharmaceutical products were registered in 2006. Unfortunately, the lack of critical understanding on this topic alone has demonstrated a deep flaw in the root of the Directive’s good intentions, and the various attempts at providing a suitable, readily accepted specification have proved largely unsuccessful. This situation has been further exacerbated by the various leading EU charities, who have not yet fully embraced the directive.

The Braille alphabet itself is not common across the EU, let alone across the world. There are still significant differences between the countries, as there would be for written languages such as French, German and English. Whilst the Braille alphabet is not uniform, a specific Braille font specification defines the spaces between the dots, and is the most commonly used Braille system for pharmaceutical packaging and labels. The EU’s guidelines on Braille requirements for labelling and packaging and The European Blind Union’s guidelines for European pharmaceutical companies both recommend that this un-contracted Braille system should be used. This is a Braille format Sessions are able to produce.

The 12th amendment to the medicines’ law requires that from the 1st September 2006, packaging in Germany must also carry the name of medicine in Braille and as Italy have already passed such legislation, the rest of the EU will not be far behind. Retailers across Europe are increasingly expanding their social responsibilities, and more product labels in Braille will be seen in the future.

Sessions of York is acknowledged to be one of the UK’s leading and most progressive manufacturers of self-adhesive labels and labelling equipment. The company supplies an extensive range of high performance labelling machines, which are available ex-stock or can be custom built to suit individual requirements. Sessions are also able to provide on-site equipment demonstrations if required.

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