The European Medicines Agency (EMA) has released recommendations concerning pack design and labelling for non-prescription medicines for a 3-month public consultation period, which will run until 30 June 2011. Such features are important for the safe use of all medicines, but are arguably more crucial for non-prescription medicines — especially when no intervention from a pharmacist is required. For this blog, I thought I’d take a an in-depth look at the recommendations and what pharma manufacturers will be required to provide, if the recommendations are enforced.
Information that should be included on the labelling and packaging leaflet is listed in Directive 2001/83/EC, while details on display and readability are provided in the European Commission’s (EC’s) Guideline on the readability of the labelling and package leaflet of medicinal products for human use. In Europe, however, packaging and labelling presentation can vary between different Member States. The new recommendations follow a consultation with Member States about their national practices. The recommendations summarise the basic principles to guide applicants and marketing authorisation holders when preparing mock-ups and specimens of sales presentations of non-prescription medicines within the centralised procedure.
Overall, the recommendations are designed to ensure that both the labelling and packaging leaflet are suitably presented and easy to understand. Some of the basic elements included in the recommendations concern the use of a clear layout, font type, and the use of colour or graphic design. The recommendations also highlight the type of information that must be featured, which includes the usual suspects of medicine name, active substance, route of administration, indications and instructions for use. Such important information should be brought together on the pack in the same field of view in clear large font.
But what’s not to be included? The recommendations advise against using italics and capital letters for entire sentences because they are hard to read (bold type is usually better). Also, careful consideration needs to be given to the colour of the package to ensure that it does not impact readability.
Companies will also need to take care when using symbols or pictograms. Although these are allowed (if relevant), they must not be confusing; for example, the number of tablets shown must not mislead about the dose. Images that are not allowed include those of leaves and fruits (text is considered sufficient to identify a medicine’s flavour), children, toys, balloons or other images that may cause confusion with other types of products.
More specific information about the recommendations is available on the EMA website.
Pharmaceutical Technology Europe will be publishing a special feature on packaging and labelling in our next issue. If you’d like to take part by giving your opinion on the new recommendations, or by discussing any other pharma packaging topics, then why not join our LinkedIn group? Or if you prefer, send us an email with your views at firstname.lastname@example.org.