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.

Application forms and templates

Form notification zonal application

Form G-CMS

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)