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Legislation Puts Braille Labelling Firmly On The Agenda For Packaging Suppliers

Meeting the ever increasing demands placed upon the packaging industry is a challenge

that Fix-a-Form International and their 22 strong network of manufacturers has worked hard to fulfil. Its a role they take very seriously too, especially where pharmaceutical and healthcare packaging is concerned. Each year in the US alone 125,000 people die as a result of non-adherence with a direct cost to the US healthcare system of around $US 100 billion. Furthermore, 31% of all medicines prescribed dont even get collected whilst an estimated 40% of those prescriptions are not taken as directed.

Clearly presented labels with easy-to-follow user-instruction provide the patient with a greater chance of adhering to the instructions whilst promoting a positive user-experience.

Sometimes there simply isnt enough space on the label to include all the information required by law and compromising the font size or reducing text is simply not an option. Fix-a-Form leaflet labels have long provided the solution to an often common packaging headache. Established during the early 1980s, the network now produces and supplies labels and labelling to over 50 countries worldwide.

One recent challenge to the packaging industry has been the legal requirement of Braille. Its a fact that over 285 million people worldwide have impaired vision. The majority of these people are elderly, a group that is prescribed nearly half of all prescription drugs.


Since October 2010 (Article 56(a) of Council Directive 2001/83/EC) Braille has been a mandatory requirement on all EU pharmaceutical packaging. This includes any pharmaceutical products which were launched prior to October 2005. Braille must show the name of the medicine and the appropriate strength, where more than one strength is available.

Whilst carton manufacturers have been well versed in the art of carton-board embossing the method of printing and producing quality Braille dots proved somewhat of a challenge to the labelling industry at first. Nowadays, thanks to a variety of proven and tested methods of technology it is possible to supply printed self-adhesive labels and leaflet labels with the inclusion of Braille dots.

Case study:


Dales Pharmaceuticals (UK) recently applied Braille to one of their vitamin supplements it manufactures.The Prescription-only Medicine (POM) pack of Ketovite Tablets* is relatively small so space was an issue in terms of label construction.

The 12 page re-sealable concertina style Fix-a-Form leaflet label included product details, storage instructions as well as manufacturer contact details. This label measures just 11.5cm x 2.5cm in size and was supplied using standard label application equipment

A spokesman for the company stated: "Clearly Fix-a-Form helps us to protect public health by improving the roll-out of patient information and so we expect to be seeing a lot more of this ingenious device on products we make in the future."

by: Suraj Anjaana
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Legislation Puts Braille Labelling Firmly On The Agenda For Packaging Suppliers