Guidelines and agencies

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

Readability guideline

European Commission, 2009

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

CMDh 2011, Rev. 1, December 2016

Guidance on the user testing of patient information leaflets

MHRA, 2005

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, December 2017

QRD bridging form

EMA, 2014, Rev. 1

QRD bridging form

CMDh, 2017

Readability guideline

European Commission, 2009

QRD template in all European Union languages

EMA, 2016

Always Read the Leaflet

MHRA, 2003

Excipients guideline in all European Union languages

European Commission, 2017

Position paper on the use of QR codes to provide information about the medicinal product

CMDh, 2016

Guideline on the packaging information of medicinal products for human use

Europaen Commission, 2015

European Medicines law: unofficial amended version of the Directive 2001/83/EC

British Medicines Act

German Medicines Law

Austrian Medicines Law

Swiss Medicines Law

Contact points of European medicines agencies

Last update: 09.04.2019

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