Netherlands Concerned Member State Zonal Application
Regulation 1107/2009 introduced a zonal system, encouraging cooperation and worksharing between Member States.
Applications for new authorisations, major amendments to existing authorisations, extending the scope of the authorisation and extending the authorisation period must be submitted according to the zonal procedure. One Member State shall act as zonal rapporteur (zRMS); this Member State assesses the application on behalf of all Member States for which the application is intended (the concerned Member States or cMS).
The zonal process consists of a zRMS part and a cMS part, that strongly intertwined act together. For information on this process of zonal application and assessment see zonal application Netherlands Rapporteur Member State (NL=zRMS).