EMEA Guidance

Guidance Concerning Consultations with Target Patient Groups
for the Package Leaflet
Article 59(3) and 61(1) of the Directive 2001/83/EC as amended by Directive 2004/27/EC

A Guideline on the Readability of the Label and Package Leaflet
of Medicinal Products for Human Use
European Commission, Pharmaceutical Comittee, 1998