Guidelines/ Laws / Competent Authorities

The relevant Guidelines, local Drug Laws and contacts to Competent Authorities with respect to the Patient Instruction Leaflet and Readability User Tests / Bridgings.

Readability User Testing

Readability guideline

European Commission, 2009

Position paper on user testing of package leaflets - consultation with target patient groups

CMDh/234/2011,Rev. 01, December 2016

Guidance on the user testing of patient information leaflets

MHRA, 2005

Q&A - Product Information/ Information on Medicinal Products

CMDh/275/2012, Rev.1, October 2017

Bridging Studies

Consultation with target patient groups -meeting the requirements of Article 59(3) without the need fora full test- recommendations for bridging

CMDh/100/2007, Rev. 3, December 2017

QRD Bridging Formular

EMA, 2014, Rev. 1

QRD Bridging Formular

CMDh/365/2017, Rev. 0, September 2017

Patient Instruction Leaflet

Readability guideline

European Commission, 2009

QRD Template in den Sprachen des Europäischen Wirtschaftsraums

EMA, 2016

Best Practice Guidance on Patient Information Leaflet

MHRA, July 2012

Excipients-Guideline in the languages of the European Economic Area
(First published: 09/10/2017
Last updated: 19/11/2018)

EMA/CHMP/302620/2017 Corr.1

CMDh position paper on the use of mobile scanning and other technologies to provide information about themedicinal product

CMDh/313/2014, Rev.8, December 2018

Guideline on the packaging information of medicinal products for human use

European Commission, July 2015

Drug Laws

European Drug Law:
Directive 2001/83/EG


Drug law of Great Britain


Drug law of the
Federal Republic of Germany


Drug law of Austria


Drug law of Switzerland


Competent Health Authorities

Contact addresses of European Health Authorities:

see button "Contact Points"