“Blue Box” for Norway in package leaflet and label
From 31 October, 2005 there will be harmonised texts for package leaflets and labels for medicinal product which have marketing authorisations through mutual recognition or decentralised procedures.
The European Commission has accepted that the “Blue Box” consept is used for the package leaflet and for the labelling of such products. This means that necessary national information will be added. The information in the package leaflet is to be placed under the adequate headings, as shown below. The national requirements will be included in the Chapter 7 of Notice to Applicants, Volume 2A and 6A.
Sist gjennomgått: 28.03.2006
Første gang publisert: 28.03.2006