Netherlands Rapporteur 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).
The regulation defines 3 zones based on the comparability of the agricultural, phytosanitary and ecological (including climatological) conditions: North, Central and South. The Netherlands is in the Central zone. For climate independent uses (e.g. indoor uses, seed treatment) the zonal partition is not used. For these uses all member states cooperate (“interzonal assessment”).
A company that wishes to place a plant protection product on the market in any EU member State, will first have to ensure that the active substance is approved, and submit a zonal application together with a complete dossier consisting of an active substance dossier for the active substances contained in the product and a product dossier to a Member State of his own choice. This member state will act as the reporting Member State (RMS). The RMS conducts a risk assessment based on active substance data and product data, the proposed instructions for use. The RMS takes a decision to grant or refuse the product authorisation applied for.
Companies can apply for product registration in other Member States at the same time an application for product registration is assessed by the Rapporteur memberstate. An application for authorisation of the product is submitted in a concerned memberstate (cMS), referring to the assessment that is carried out by the RMS (an application in concerned Member State).
Minor uses (art 51, PPPR 1107/2009) can be part of a zonal application.
An application for registration can be submitted at any point after the zonal application for initial authorisation has been granted by a zRMS (see mutual recognition).