Registration process (NL=zRMS)
Zonal Application
The basic procedure for the authorisation of a new plant protection product (PPP) and subsequent authorisation in other EU Member States is as follows:
- An application is made to the EU country/countries where the Plant Protection Product is intended to be placed on the market via the PPP Application Management System. A zonal Rapporteur Member State (zRMS) is selected for each zone where the PPP shall be authorised. For interzonal applications some uses may be assessed by a single Member State on behalf of all zones.
- The zRMS carries out an assessment of the application.
- The concerned Member States in the zone comment on the zRMS's evaluation (dRR, core assessment).
- The zRMS finalizes the registration report and makes a decision on whether to grant or refuse an authorisation.
- Concerned Member States make a decision to grant or refuse an authorisation.
In case an authorisation is already issued in zRMS and the applicant wishes to place the same product on the market in another Member State(s), an application is made for 'mutual recognition' of the product in the concerned Member State.
Note 1:
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.
Note 2:
In the EFSA conclusion regarding the (renewal of the) approval in some cases data gaps are defined. What does this mean for applications for registration of products based on this active substance? For each of the following cases a harmonised procedure has been agreed within Europe:
- Data gap in EFSA conclusion for an active substance and/or its metabolite that is not identified as ecotoxicologically or toxicologically relevant in the Review Report:
Data gap is not to be considered at PPP level because it is not relevant. - Data gap in EFSA conclusion for an active substance and/or its metabolite that is identified as ecotoxicologically or toxicologically relevant in the Review Report:
Data gap needs to be considered at PPP level because it is relevant.* - Data gap in EFSA conclusion, and set as confirmatory data in the Review Report:
Data gap needs to be considered at active substance level, in line with the confirmatory information guidance.**
Confirmaory data may not be taken into account at PPP level until “taken note” at Standing Committee - PAFF.
However, an exemption is made when the data is essential to exclude serious human health and environmental risks for the PPP use(s); then it needs to be taken into account at PPP level.* - Data gap in EFSA conclusion, and set as a Member State issue in the Review Report:
Data gap needs to be considered at PPP level unless it concerns active substance data; which should be dealt with by the RMS at active substance level, in line with the guidance on new a.s. data post approval.*** - Data gap in EFSA conclusion, and not identified in Review Report:
In principle, the evaluation of the data gap will not be performed before the next active substance approval/renewal. However, an exemption is made when the data is essential to exclude serious human health and environmental risks for the PPP use(s); then it needs to be taken into account at PPP level.*
* Provided that the data do not implicate a change of a toxicological endpoint; AOEL, ARfD or ADI. In such cases consideration by the RMS at EU level is needed, and the new list of endpoints need to be taken note at SCoPAFF before it can be used at product level.
** Guidance document on the procedures for submission and assessment of confirmatory information following approval of an active substance in accordance with Regulation (EC) No 1107/2009 (SANCO/5634/2009).
*** Guidance document on the evaluation of new active substance data post approval (SANCO/10328/2004)(note: new version expected in 2021).
Timeline Zonal Application
Within 12 month the zRMS must decide on the authorisation of a zonal application. This period may be extended by max. 6 months Stop-the-clock (while waiting for additional data of the applicant).
- Applicants are requested to submit a notification 6 month before submission of the application at the latest. The applicant indicates which Member State will be the zonal rapporteur and to which concerned Member States the application will be submitted for authorisation. Notification only necessary for Applications art 33 PPPR (new authorisations and amendments) not necessary for renewal of product authorisations (art 43 PPPR).
In the six months before receiving the application, a pre-submission meeting is recommended , during which the applicant presents the dossier and the zRMS gives a first indication of the quality of the dossier and a strategy for open points can be discussed. - At T = 0, the application is formally submitted. After the submission, Ctgb has 12 months to complete the final zRMS registration report and decide on the zRMS product authorisation. For applications based on active substances that are approved as low risk the legal timeline is not 12 moths, but 120 days.
The Ctgb starts with the intake (an inventory of the dossier). If data are missing, the Ctgb can request the applicant to submit these data. The deadline is suspended (stop-the-clock 1) for max 2 weeks.The agreements made in the pre-submission meeting will also be taken into account. - After receiving the missing data, Ctgb will start with the preparation of the core draft Registration Report (dRR) and the draft national addendum. Within 6 months after receiving the application, the Ctgb must indicate whether additional information is required to demonstrate a safe use.
- If additional information is required, then again the deadline will be suspended (stop-the-clock 2) enabling the applicant to supply the additional information within the time period specified by the Ctgb. As defined in the PPPR 1107/2009, the total duration of ‘stop-the-clock 1’ + ‘stop-the-clock 2’ can be no more than 6 months. The time period specified by Ctgb to supply additional information, should leave the Ctgb at least 2 months to finalize the core dRR. For product applications based on a low risk active substance, the stop the clock period for answering additional questions is also max. 6 months.
- Excluding the stop-the-clock period, the core dRR must be ready for peer review by the EU member states at T = 8 months at the latest. Before a dossier is sent out for the EU commenting round, the Board will give its consent on the dossier. During the commenting round, also the applicant will receive the dRR and has the opportunity to comment on the dRR. The applicant is also asked to check if the dossier includes confidential information. It is not possible to add studies or new information in this stage of the evaluation.
- Member States of the zone(s) can 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. For low risk applications this commenting period is 3 weeks.
- After receiving the commentary, the Ctgb has the time remaining until T = 12 months (± 2,5 month) to finalize the zRMS registration report + 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.
In its decisions (published on the internet), the Ctgb includes Part A and B of the Registration Report (RR). Parts C contains confidential information and is therefore not published. The applicant will also receive the Parts A, B and C (digitally), and these parts are also placed on CIRCA BC so that all competent authorities in Europe have access to the complete RR.
Timeline zonal low risk application
