Instruction for submission (NL=zRMS)

Before submission

When preparing the application, applicants should contact the zonal Rapporteur Member State of their choice, with the request to process the application. For the Netherlands, applicants can contact Mr Geert-Jan Molema, at least six months before you intend to submit the application. When agreement has been reached with the zRMS, the completed form 'notification zonal application' must be submitted to the zRMS and all cMS (only necessary for application for new authorisations and amendmends (art 33 of PPPR), not necessary for applications for renewal (art. 43 of PPPR).

If required, the central zone Steering Committee (czSC) will coordinate the distribution of the work amongst the Member States. Six months before submitting the application, the applicant can propose a Member State as zonal rapporteur to the czSC.

If the Netherlands is the rapporting memberstate, the Ctgb highly recommends the applicant to request a Pre-submission Meeting before the application is submitted. During this meeting, the content of the application is discussed and inventoried with the applicant (see Pre-Application Support).

Application forms and templates

The content and structure of dossiers is precisely and comprehensively defined in several guidance documents.  From January, 1, 2017, the revised templates for the draft registration report have to be used for applications for authorisation as well as for applications for extension or renewal of authorisations for which the data requirements of Regulation (EU) No. 284/2013 apply. If the active ingredient is a microorganism, the old dRR format (B1-B7) is still applicable.

Reference lists:

Part A and each section of Part B (including national addenda) should have 4 reference lists of tests and studies as Appendix 1. Two lists need to be filled by the applicant (“All studies required to address the data points in the dRR and not previously evaluated at EU level” & “All studies required to address the data points in the dRR and already evaluated at EU level”). Each reference should only appear in one of the two lists. All 4 reference lists need to be considered by the zRMS (i.e. the first two lists and ”Data not relied on” & “Data not submitted but relied on”). Such data lists should be prepared in the format as required in SANCO 12580/2012.  If additional data are submitted during the evaluation, they should be added to the lists in the dRR. An updated data list should be supplied by the applicant. Note that the applicant must also indicate in the list in part A (provided separately for each country in the zonal/interzonal application) for which studies protection was claimed, as necessary to meet the requirements of Art 60 (2 b).  For more information about the dRR format please refer to SANCO/6895/2009 rev 2.2:  Technical guidelines on the presentation and evaluation of plant protection product dossiers in the format of a (draft) Registration Report.

Minor uses: in the GAP table, minor uses have to be specified and identified separatly, by using a separate line in the GAP table for every minor use (see also explanation in template of the GAP). Note: when a minor use is not identified as such in the GAP table  and draft label, it will not be assessed like a minor use and not registered as one.

 Application forms, instructions and addenda

Form notification zonal application

Form G-zRMS

dRR template

Instruction and forms Legal use (WG)

professional  and non professional use

Addenda:

LoA (Part A section 1)

GAP (Part A section 2)

Reference list

Reference list vertebrates

National addenda:

Efficacy NL (Part B section 3)

Environmental Fate NL (Part B section 8)

Ecotoxicology NL (part B section 9)

Check for completeness application

The application for a zonal authorisation should consist of the following documentation:

  • Cover letter
  • Form Notify Zonal Application (already sent 6 month before product application)
  • Form G – zRMS
  • dRR + National addenda
    • LoA (Letter of Access)
    • Concept WG (Legal instructions for use)
    • GAP (Description of use)
  • Reference list
  • Supporting data, if relevant. Summaries + Trial/study reports (Caddy)

When The Netherlands is zonal Rapporteur member state, but no authorization of the product is applied for in The Netherlands, the application for a zonal authorization should consist of the following documentation:

  • Cover letter
  • Form Notify Zonal Application (already sent 6 month before product application)
  • Form G – zRMS
  • dRR (without part A and other national addenda)
  • LoA (Letter of Access)
  • GAP (Description of use)
  • Reference list
  • Supporting data, if relevant. Summaries + Trial/study reports (Caddy)