Guidelines and agencies

We support you with an overview of guidelines and agencies relating to package inserts and readability user tests.  

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

Readability guideline

European Commission, 2009

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

Always Read the Leaflet

MHRA, 2005

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

Readability guideline

European Commission, 2009

QRD template in all European Union languages


Excipients guideline in all European Union languages

European Commission

Guideline on the packaging information of medicinal products for human use

European Commission, 2016

British Medicines Act

Austrian Medicines Law

Swiss Medicines Law

European Medicines law: Directive 2001/83/EC

German Medicines Law

Contact points of European medicines agencies

Last update: 13.07.2024

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