Assessment framework and start of time lines
The application requirements are fulfilled when also the application fee is received by Ctgb.
- For the timelines, Ctgb starts counting from the formal registration date (= the date when both the application and payment have been received).
- For setting the assessment framework for the evaluation, Ctgb considers the date the application letter is received by Ctgb. In case the renewal for 2 or more active substances is done in a single evaluation the assessment framework is determined on the date receiving the application for the product renewal for the second active substance. See LINK B - Renewal for 2 actives in a single evaluation.
The basic procedure for the renewal of a Plant Protection Product authorisation is as follows:
The basic procedure for the authorisation of a PPP renewal and subsequent authorisation in other EU Member States is as follows (art 43 of PPRE (EU) 1107/2009):
- The Central Zone Steering Committee will take the initiative for an inventory with all authorization holders of their intentions to renew their current PPP formulations within the Central Zone and divide the zRMS workload among the Member State Competent Authorities. The inventory is done by AIR batch of active substances.
- Within 2 months after publication of the EFSA conclusion for the active substance renewal, the authorization holder needs to submit a notification for the intended product renewals to Ctgb as intended zRMS or CMS.
- Within 3 months of the DoA (Date of Application) set in the renewal regulation of the approval of an active substance, authorisation holders must apply to renew the authorisations of PPPs containing that active substance. The applicant has to submit applications in all the Member States in which he wishes to renew existing PPP authorisations (article 43 of PPPR (EC) 1107/2009).
- The zRMS carries out an assessment of the application within 6 months after submission (article 43 of PPPR (EC) 1107/2009).
- The concerned Member States in the zone comment on the zRMS’s evaluation; the commenting period for renewals is 3 weeks and should be scheduled in the 5th month after application in order to meet the 6 months-deadline.
- The zRMS finalizes the registration report and if applicable decides to grant or refuse an authorisation on a national level in the 6th month after application.
- Based on the core Registration Report, concerned Member States evaluate the national addenda and decide to grant or refuse an authorisation on their national level within 3 months after the final RR is published by the zRMS (article 43 of PPPR (EC) 1107/2009);
Once an authorisation is issued and the applicant wishes to place the same product on the market in other than the CMS Member States, an application for ‘mutual recognition’ under article 40 of PPPR (EC) 1107/2009 may be submitted.
Ctgb aims to follow the time lines set out in article 43 of PPPR (EC) 1107/2009. However, it is generally acknowledged that the timelines set in article 43 are very tight for most renewal applications. Originally the renewal evaluation was seen as an update of the evaluation on a few specific aspects in the dossier. However, in many cases, the last complete evaluation of the product is 10 or more years old and for many aspects Guidance has been updated in the meantime. Additionally, for many products it also is the first evaluation in dRR format. So the re-assessments turn out to much more extensive than originally foreseen and Ctgb, like other Member State competent authorities, is challenged to complete the renewal evaluations in a short time frame and may not always succeed. In such cases Ctgb will inform the applicant and CMSs as soon as a delay can be foreseen.
Extension of submission deadline for the dRR
The EU GD art 43 PPP renewals defines two reasons for which the deadline for submission of the dRR may be extended
- ‘category 4 studies’
- Renewal for 2 actives in a single evaluation
The decision for such an extension lays with the zRMS for the product renewal.
IMPORTANT NOTICE !
Even though the zRMS has agreed to postpone the deadline for submission of the dRR, an application should always be submitted 3 months after the Date of Application (DoA) of the (first) active substance renewal. See details on our page Extension of submission deadline for the dRR.
Data matching check by RMS of the active substance renewal
In case the applicant for a PPP renewal is not the notifier of the active substance renewal, the applicant has to prove access to active substance data; either through a Letter of Access from the notifiers, by submitting a matching study or prove of access to it, or by argumentation based on public literature or non-protected data that the study is not required. In such cases the product renewal application should include a data matching check, which is executed by the RMS of the active substance. A list of data relied upon for the active substance renewal prepared by the RMS of the active substance is published on the EU pesticide database.
So applicants wishing to use matching active substance data, need to apply for the data matching check with the RMS of the active substance, next to their applications in the ZRMSs and CMSs in various EU-zones.
See details on our page Data matching check.