College voor de toelating van gewasbeschermingsmiddelen en biociden

4 Submission of application to Ctgb

4.1 Submission deadline and requirements

In all cases, when Ctgb acts as CMS or ZMRS, the submission deadline for the application for a PPP renewal to Ctgb as ZRMS or CMS is 3 months after the DoA set in the EC renewal regulation of the active substance (art. 43.2 of Regulation 1107/2009).

  • If no postponements were agreed in advance (see section 3.5 and 3.6), the application should contain a complete dossier (see section 4.2 below) including all studies and the dRR.
  • In case the ZRMS or Ctgb as ZRMS agreed to allow time for generating category 4 studies (EU GD art 43), the application should contain a complete dossier (see section 4.2 below) minus the new studies and the dRR. Submission of the dRR can be postponed to the date agreed for the submission of new studies.
  • In case the ZRMS or Ctgb as ZRMS agreed to combine the renewal for two active substances in a single evaluation, the application should contain a complete dossier (see section 4.2 below) for the first active substance minus the dRR. Submission of the dRR can be postponed to the submission deadline of the application for the second active substance.

Please also refer to the appendix II of EU GD art 43.

4.2 Dossier requirements

For the general dossier requirements, Ctgb refers to the EU GD art 43 section 3.3 and the Ctgb application forms and general instructions. Applicants should use the application form G-ZRMS for Zonal application Netherlands = ZRMS or application form G-nZRMS for Zonal application Netherlands = CMS. 
Additional information is set out below:

  • dRR with Core and national addenda in the new dRR format with new data requirements (submission dRR from 1 January 2016).

    Exceptions for AIR2 renewals

    • Ctgb will accept a dossier based on the old data requirements in the old dRR format for dRRs submitted before 1st January 2017.
    • For submitting a dRR after 1st January 2017 the new dRR format has to be used, the new data requirements may be left open.
    • Applicants are free to use the new dRR format before 1st January 2017.
    • Applicants should stick to the chosen dRR format for the whole dRR and not mix old and new format within or between Core and National addendum.
    • Applicants are free to use the new data requirements, but this should be confirmed in the submission letter and is irrevocable.
  • If the ZRMS accepts the old dRR format for AIR 2 renewals after 1st January 2017, Ctgb will accept the same for the CMS application.
  • The dRR should be submitted in MSWord file format.
  • The dRR should be updated for the active substance under evaluation. The data for the other active substance will not be evaluated and therefore do not have to be updated except that combitox has to be worked out.
  • A renewal dRR for Ctgb evaluation should include updates for conditions and restrictions in the renewal regulation of the active substance, new endpoints and new Guidance Documents in force on the date the application is received by Ctgb. New data requirements apply for dossiers of AIR3- and AIR 4-based PPP renewals.
  • An electronic copy of all underlying studies in PDF or MS word file format.

Specific dossier requirements that apply to double PPP renewals (CMS and ZRMS): To be filled in.

4.3 Specific points of attention for aspects

Still to be elaborated for all aspects.

Efficacy

In the standard case that the GAP does not contain major changes, the efficacy section should contain only a well-build update of the resistance paragraph and monitoring data when applicable. No fully filled dRR has to be submitted. For the other sections of the dRR B7 you can refer to previous evaluations. No national addendum is foreseen. In this case no BAD or underlying studies are required.

In the case that GAP changes are accepted, Ctgb as ZRMS and the applicant should discuss if and if yes, how many, new efficacy trials are needed for the changed uses. Such studies may be categorized as category 4 studies for which extension the submission deadline of the dRR can be agreed on. Applicants are advised to address this subject in the presubmission phase (see in section 3). In this case, a BAD and more efficacy sections in the dRR likely need to be updated.

4.4 Confirmatory data

Confirmatory data set in the renewal regulation of the active substance may lead to a data gap in the PPP dossier. Ctgb will not evaluate these subjects, conform the EU GD art 43 section 3.3 but leave this to the RMS of the active substance. Ctgb may re-evaluate PPP authorizations for these particular points after renewal if the CD evaluation of the active substance gives reason to do so.

4.5 Amendments are not accepted (with a few exceptions)

In contrast with the procedures for reregistration, the EU GD art 43 for renewal applications does not allow for any amendments from the current authorization on a national level, even if the use is already authorized in another member state and included in the Core.
This rule can be explained as the evaluation for a renewal is focussing on the changed details of the dossier for only a single active substance, and not on all aspects of the PPP as a whole.

Exceptions:

 

  • Non-significant changes in the formulation as defined in GD SANCO/12638/2011.
  • Restrictions of the GAP needed to bring the authorization in compliance with new endpoints and new conditions and restrictions confirmed at the active substance renewal, or new guidance and data requirements applicable at the date the application is received by Ctgb.
  • Ctgb considers withdrawal of complete uses (GAP lines) from the label as permissible. However, applicants should consider that this may have consequences for other uses as well in case these were based on a risk envelope approach.
  • Spray volumes: The Dutch national standards for spray volumes have changed in the course of time. Amendments in the spray volume to comply with the current list are permissible, but may have consequences for the risk assessment (especially operator exposure), that should be covered. However, Ctgb cannot foresee how other ZRMSs will handle this point as it can be considered as a national Dutch guidance. Applicants can use this as their argument to incorporate the change in spray volume for ZRMSs.
Applicants are advised to discuss amendments in advance during a presubmission meeting, Request for Meeting or Service Desk question with Ctgb before the application is submitted. In case Ctgb is ZRMS, and the changes apply to a use in another CMS, we also advise to contact the CMS authorities to get their agreement.

Amendments should be submitted with a justification which will be evaluated by Ctgb in the intake phase of the application process. In case of CMS applications, Ctgb may need to charge additional fees as the CMS standard tariffs for renewals are based on standard dossiers without amendments.

How to apply for new uses, voluntary GAP changes and significant formulation changes?

Applicants that wish to make amendments in their Dutch authorization, e.g. because of their wish to harmonize GAPs or formulations across the zone in their renewal dossiers, or to add new uses, are advised to apply for these well in advance of the renewal application via an article 33 or art 40 application. If finished before the submission deadline for the PPP renewal applications, the amendments should again be included in the renewal application.  However, under no circumstances Ctgb can guarantee that any individual application will be finished before the submission deadline of the renewal application. Alternatively these changes can be applied for after the renewal of the PPP, again via art 33 or art 40.
It may be possible to run applications for renewal and applications for extensions or other amendments in parallel, leading to efficiency gain.

Ctgb currently studies the legal and practical aspects of applications for amendments around and during PPP renewal evaluations. Product authorizations may otherwise be ‘fixed’ for a considerable period of time as a consequence of the no-amendments policy in article 43 and the possible extension deadlines for submitting category 4 data. To be further filled in.

4.6 Minor uses

Existing minor uses should be included in the renewal Core dossier as far as the applicant has access to the supporting data (owner, via LoA, or data protection has expired). This is usually the case for Dutch minor use authorizations.

In case the data for the minor uses are exclusively owned by a grower association they may be included in the national addenda as long as the corresponding risk assessment is presented in the addenda. These will be checked by the individual CMSs or Ctgb if Ctgb is CMS for the application.

In case an existing minor use can no longer be registered as such and has to fulfil the criteria for a major use, this is regarded a major amendment of the GAP which should be applied for under art 33.

New minor uses cannot be incorporated in the renewal application. See above in section 4.5 on amendments. New minor uses can be applied for during the renewal evaluation via the Ctgb NLKUGH procedure based on the new List of Endpoints. See also: Minor uses.

4.7 Fees

For renewal applications, Ctgb will apply the standard fee structure for zonal applications ZRMS and CMS to be paid at the submission date of the application (3 months after DoA of the renewal regulation of the active substance). [Link fee structure].

Voluntary presubmission meetings, requests for meetings and/or Service Desk questions in advance of the application are invoiced separately. See Service Desk.


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