Why does the information provided in the package leaflet vary between generic products?
The information provided on the package leaflet provided with a generic medicine may differ slightly from that of the reference product or another generic product. This is due to the requirements imposed during the marketing authorisation application process. Under the EU arrangements, one member state will be responsible for assessing marketing authorisation applications for a single generic product on behalf of the other member states. The member state in question will compare the information provided on the generic package leaflet to the information provided in the reference medicine package leaflet in that country. Thus, the information provided may vary between member states unless the information has already been harmonised.