Instruction for submission NL=CMS
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 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 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)
Forms
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Zonal application The Netherlands CMS
Application for authorisation or amendment of an authorisation of a plant protection product, including micro-organisms, for ...
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Template to notify intended zonal applications
Template to notify intended zonal applications under Article 33 and Article 43 of Regulation (EC) No 1107/2009