Readability / user consultation

Applicants are obliged to conduct a readability test report and present its findings to the drug authority in the corresponding country. Since 2005, the European Directive for human medicines, requires that every product information leaflet (PIL) should be “legible, clear and easy to use”.

Since the aim of a marketing authorisation holder (MAH) is to reach every demographic group which can benefit from a given medicine, ensuring that the braille writing on the medicinal cardboard box is present is also of an importance and must be included in most cases.