Registration process (NL=CMS)
The basic procedure for the authorisation of a new plant protection product and subsequent authorisation in other EU Member States is as follows:
Zonal application
- The applicants are requested to submit a notification at the latest 6 month before submission of the application. The applicant indicates which Member State will be the zonal rapporteur and to which concerned Member States the application will be submitted for authorisation.
- At T = 0, the application is formally submitted. The applicant has to submit the dRR (core dossier) to Ctgb as intended concerned Member State simultaneously with submission of the dRR to zonal rapporteur. An application is made to the EU member state(s) where the plant protection product is intended to be placed on the market via the PPP Application Management System. Ctgb supports the use of PPPAMS.
After submission, the zonal rapporteur Member State has 6 – 8 (at the latest) months to complete the draft registration report; this period may be extended by 6 month Stop-the-clock to allow the applicant the delivery of additional data. The applicant should submit the national addenda for the Netherlands up to 6 months after submitting the dRR (core dossier). This means that the national addenda must be submitted to the Ctgb before the commentary round begins. - In the commentary round concerned Member States of the zone peer review the assessment made by the zRMS . From the time of delivery of the zRMS draft registration report, the concerned Member States involved have 6 weeks to provide written commentary. After receiving the commentary, the zRMS has the time remaining until T = 12 months after the submission, to complete the final zRMS registration report and decide on the zRMS product authorisation.
- After publication of the zRMS registration report and the product registration in the zRMS, the concerned Member States have a period of 120 days to decide on the product authorisation on their territory. All requested uses must fall under the risk envelope, as evaluated in the RR. Consequently, it is not possible to add additional uses to the CMS application if these were not assessed in the RR.
Note:
Uses in “walk-in tunnels” are assessed in a zonal procedure. These uses have to be taken up in the zonal core dRR. for more explanation, see: Evaluation manual chapter fate and behaviour.
