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Labelling: Legibility and Compliance

 

According to EU regulations, patient instructions on medicines should be easy to read. The EU has therefore produced a new recommendation stating that the instruction text should now have a 9-point type size, rather than the previous 8. The recommendation applies to both packet inserts and folding labels. In practice, this means that the text will require 20 per cent more space than before, thus generating new demands, including a greater number of pages in the patient instructions. This raises the question of whether pharmaceutical manufacturers will have to replace the popular folding labels with a combination of outer packaging and inserts – a more expensive solution both in terms of materials and production processes. However, compliance with the new recommendation can easily be attained through the use of a labelling solution.

EU Regulations Require Good Readability

The recommendation regarding the font and type size of text in the patient instructions is found in ‘Guideline on the readability of the labelling and package leaflet of medicinal products for human use,’ (Revision 1, 12th January 2009). The new recommendation came into effect on 12th June 2009. The type size of 9 points replaces the previous recommendation for 8 points. The type size is defined on the basis of the Times New Roman font, and the space between the lines should be at least 3mm. The recommendation reflects the spirit of the directive, which is that of ensuring that user instructions are easy to understand, and that the text should be clear and legible, so showing consideration for the patients. Thus far, pharmaceutical manufacturers seem keen to comply with the new guidelines, because they want the best possible patient safety. As specialists in folding labels for the pharmaceutical industry, this problem is very relevant to us. Pharmaceutical companies traditionally follow the EU’s recommendations, which is confirmed by Lars Bech Pedersen, Head of Information for the Lægemiddel Industri Foreningen i Danmark (Danish Association of the Pharmaceutical Industry).

Folding Labels with More Pages

Customers are unsure whether compliance with the new recommendation can be achieved within the physical framework of existing user instructions – which are either designed as a folding label or an insert – when the number of pages increases by 20 per cent. Converting to alternative solutions would be very expensive. It is often possible to create space for extra text by About the Author adding pages to the existing label construction. Normally, a folding label could contain up to 40 pages, but the use of thinner paper could increase the number of pages. Even small format changes can reduce the need for more pages. On occasions, a special construction using up to 80 pages could be used.


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Kurt Kjellerup is Director of New Business Development, Healthcare division at CCL Label in Copenhagen (previously Iwaco A/S). Kurt is an industry veteran who pioneered the use of folding labels on medicinal products. He has worked in the label industry for almost 25 years, and he introduced the Fix-a-Form® folding label format for the pharmaceutical industry in Northern Europe.
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Kurt Kjellerup
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