This page provides you some useful hyperlinks with Directives, Guidelines and articles concerning the regulatory requirements around readability and usability of patient information leaflets.
Guideline on the readability of the label and package leaflet of medicinal products for human use (September 1998) :
Law (07/05/2004) modified on 27/12/2004.pdf
Guidance concerning ‘consultations with target patient groups’ for the package leaflet :
Guidance concerning consultations with target patient groups.pdf
MHRA guidance on the user testing of patient information leaflets :
Guidance on the user testing of patient information leaflets.pdf
Always Read the Leaflet, Getting the best information with every medicine. Report of the Committee on Safety of Medicines, Working Group on Patient Information (2005) :
http://www.mhra.gov.uk/home/groups/pl-a/documents/publication/con2018041.pdf
Quality Review of Documents group (QRD) annotated template that provided the format for all patient leaflets in Europe :
QRD.pdf
