Update des QRD-Templates und daraus resultierende Änderungen in Packungsbeilagen und Fachinformationen
Dr. Jörg Fuchs1,2, Elke Anna Götze1, Christin Scheunpflug1
PAINT-Consult®1, Jena, und Lehrstuhl für Drug Regulatory Affairs, Universität Bonn2, Bonn
Update of the QRD Template and Resulting Changes in Package Inserts and SmPCs
Version 8 of the QRD template for centralised procedures, published in 2011, contains a number of positive changes which especially affect package inserts. For example, in the package insert there is now more information pertaining to children as well as stronger phrasing of the medicines’ benefits. Additionally, headings and general texts were amended. The following article provides options for implementing these new requirements while avoiding an increase in the volume of text, particularly in package inserts.
pharmind 2011, Nr. 4, Seite 670