According to its articles 59(3) and 61(1) Directive 2001/83/EC, as amended by Directive 2004/27/EC, requires that since 30 October 2005 all new marketing authorization applications in Europe must include a section on “consultation with patient target groups” in Module 1.3.4.
Patient Information Leaflet has to “reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use”.
Legal basis
