Instruction for submission
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
Instruction and forms Legal use (WG)
LoA (Part A section 1)
GAP (Part A section 2)
Reference list vertebrates
Efficacy NL (Part B section 3)
Environmental Fate NL (Part B section 8)
Ecotoxicology NL (part B section 9)
Instruction Composition Statement
Appendix Composition Statement
Mile stones for data submission
- Submission application
Check for completeness application
For Mutual recognition, the applicant should submit digital files by CR-ROM to Ctgb of the documents necessary for the evaluation. Besides a signed application form and, if applicable, a signed Letter of Access should be sent on paper.
The Ctgb is legally obligated to comply with data protection regulations. In practical terms this means that if the application contains references to data owned by third parties, the applicant must demonstrate that they are entitled to access this data. This is arranged by means of a Letter of Access.
The following documents are requested and should be sent to Ctgb:
- Form WERG
- dRR Core Dossier
- dRR National Addenda*
- Wettelijk Gebruiksvoorschrift (WG: legal instructions for use)
- GAP Table NL
- Letter(s) of Access (LoA)
- Reference List
- Reference list vertebrate studies
- Part A for the Netherlands
- Efficacy NL-addendum (Part B section 3)
- Environmental Fate NL-addendum (Part B section 8)
- Ecotoxicology NL-addendum (part B section 9)
These documents should be brought in line with the RR. Minor changes that are requested in the Netherlands must always be covered in terms of risk by the RR. All requested uses must fall under the risk envelope, as evaluated in the RR. Consequently, it is not possible to assess additional uses if these were not assessed in the RR.
It happens that the zRMS shifts a core-specific point to the Member State level. These points must then be addressed by the applicant in the national addenda. In the core dossiers referred to in mutual recognition applications, shifting of core-specific points to the Member State level often is not defined as such. N.B. Lacking data on core-specific points will have consequences for the procedure and the foreseen time schedule.