Guidelines/ Laws / Competent Authorities
The relevant Guidelines, local Drug Laws and contacts
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
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Drug law of Great Britain
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Drug law of the
Federal Republic of Germany
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Drug law of Austria
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Drug law of Switzerland
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Competent Health Authorities
Contact addresses of European Health Authorities:
see button "Contact Points"