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MerkenQRD Template Texts Intended for Package Inserts
Rubrik: Originale
(Treffer aus pharmind, Nr. 09, Seite 1540 (2012))
Wolf##8201; A | Fuchs
QRD Template Texts Intended for Package Inserts / Development from the first QRD template up to the new draft of July 2012 · Wolf##8201; A, Fuchs2 J | Schweim H2 J, Schweim H · 1Department of Drug Regulatory Affairs at the Institute of Pharmacy, University of Bonn, Bonn, Germany und 2PAINT-Consult®, Jena, Germany
Package insert Package leaflet QRD group QRD template Readability guideline Readability test When Directive 92/27/EEC came into force in 1999, it became mandatory that a patient information leaflet was provided with all medicines distributed within the European Union (EU) [ 1 ]. This information – also known as the package insert – should enable patients to use their medicines properly and create awareness of when to seek further medical advice. With the intention of harmonising the structure and content of this product information, the Working Group on the Quality Review of Documents (QRD) was established in June 1996 by the ...
