Packungsbeilagen / Packmittel
Guideline on the packaging information of medicinal products for human use
Europäische Kommission, 2016
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
Excipients-Guideline in den Sprachen des Europäischen Wirtschaftsraums
Europäische Kommission
Always Read the Leaflet
MHRA, 2005
QRD Template in den Sprachen des Europäischen Wirtschaftsraums
EMA
Lesbarkeitstest
Guidance on the user testing of patient information leaflets
MHRA, 2005
Position paper on user testing of package leaflets - consultation with target patient groups
CMDh 2011, Rev. 1, Dezember 2016
Readability guideline
Europäische Kommission, 2009
Bridging
QRD Bridging Formular
CMDh, 2017
QRD Bridging Formular
EMA, 2014, Rev. 1
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
Arzneimittelgesetze
Europäisches Arzneimittelgesetz: Direktive 2001/83/EG
Deutsches Arzneimittelgesetz
Österreichisches Arzneimittelgesetz
Britisches Arzneimittelgesetz
Schweizerisches Arzneimittelgesetz
Zulassungsbehörden