We support you with an overview of guidelines and agencies relating to package inserts and readability user tests.
Readability user tests (RUT)
Readability guideline
European Commission, 2009
Position paper on user testing of package leaflets - consultation with target patient groups
CMDh 2011, Rev. 1, Dezember 2016
Guidance on the user testing of patient information leaflets
MHRA, 2005
Bridging
Consultation with target patient groups - meeting the requirements of article 59(3) without the need for a full test - recommendations for bridging
CMDh 2007 Rev. 3, Dezember 2017
QRD bridging form
CMDh, 2017
QRD bridging form
EMA, 2014, Rev. 1
Package leaflets / Labelling
Readability guideline
European Commission, 2009
QRD template in all European Union languages
EMA
Always Read the Leaflet
MHRA, 2005
Excipients guideline in all European Union languages
European Commission
CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product
CMDh, 2018
Guideline on the packaging information of medicinal products for human use