Netherlands Concerned Member State Zonal Application

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).

Realignment of policy on mutual recognition and CMS applications

In 2025, the mutual recognition policy and CMS applications were realigned. Effective January 1, 2026, the Ctgb will no longer actively monitor the core assessment for completeness and accuracy when processing national elements of the application. Our guiding principle here is "accept, unless." This approach will lead to faster and more consistent decisions. See our policy Realignment of policy on mutual recognition and CMS applications.