The European Medicines Agency Offers Recommendations on Pack Design and Labeling

The European Medicines Agency has released recommendations on pack design and labeling for centrally authorized non-prescription drugs and is accepting industry comments through June 30. While such labeling currently must comply with Title V of Directive 2001/83/EC, package design does vary depending upon member states. The EMA offers its advice on the placement and treatment of certain medication information in an effort to encourage proper selection and use.

The draft document summarizes general pack design and layout as well as the use of symbols and pictograms, offering specific recommendations. For instance, the medicine name should appear in a large font and be used in "three non-opposing sides of an outer carton (including one end panel)," reads the document. The administration route should be displayed "in the same field of vision as the rest of the critical information," and the "largest type size possible should be used on all components."

For multiple-language packaging, "the information should be grouped per language," and a "clear demarcation between each of the languages is recommended," the document reads.

Colour is described as a "useful way to differentiate between packs," and colour distinguishing different strengths is "strongly recommended." However, the use of "different colours in the name of a medicine" is "discouraged," as is the use of too many colours.

The document was prepared by the Working Group on Quality Review of Documents after consulting Member States on national practices regarding pack design and labeling. For more details, read the PDF on the EMA's website.

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