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Instruction for submission

Before submission

Before you submit the application for an extension with a minor uses in a major crop (for example due to the type of soil or unusual pest or disease) you require substantiation from the Minor Uses Desk of the Netherlands Food and Consumer Product Safety Authority. You can submit a request for this substantiation to this email address: loketkleinetoepassingen@minlnv.nl

Pre-submission support

When you have questions related to an extension with minor uses, you can contact the Service Desk.

Application forms and templates

The data content and structure of the dossier is defined in application form and appendices presented below.

Application forms, instructions and addenda

Form NLKUG and explanation

Instruction Drafting WG

Addenda
Instruction drafting GAP and
GAP table of uses (WORD-format)


Appendix Reference list (including extra data
protection and vertebrates

Milestones for data submission

  • Notification, contacting the Ctgb account manager for plant protection products
  • Submission of application for national extension of an authorisation with minor uses
  • Opportunity given by the authority to provide missing data (required to solve data gaps in the submitted dossier) or supplementary data (required when the assessment indicates that on basis of the submitted data no safe use can be demonstrated).  N.B. ambiguities, missing data and the need for supplementary data will delay the processing of the application.

Additional data protection pursuant to Article 51, extension for minor uses

For the NLKUG procedure, the Ctgb has produced a reference list in which applicants wanting to claim additional data protection must list all the information on data protection that is ongoing at the time. When submitting the reference list, the justification for claiming data protection must also be given.

What does the Ctgb require for a national application for extended authorisation with minor uses?

In support of the application, applicants should provide information that shows that the intended uses are small in nature (according to the Regulation PPPR 1107/2009: “minor”).

The application for extension of a national authorisation with minor uses should consist of the following:

  • a completely filled-in application form for minor use (NLKUG ).
  • a substantiation that the desired extension of uses concerns a minor crop, or in case of a minor use in a major crop, a substantiation from the Minor Uses Desk of the Netherlands Food and Consumer Product Safety Authority.
  • the Legal Conditions for Use (and instructions for use).
  • the GAP (Good Agricultural Practice) with data about the intended use.
  • available relevant studies or statements, for example concerning maximum residue levels.
  • if you are not the authorisation holder: a Letter of Access (LoA) from the authorisation holder.
  • Reference list (including extra data protection and vertebrates, if relevant)

Costs

For the corresponding costs, refer to the Ctgb Tariffs Decree. The Ctgb requires an advance payment and charges the actual fees for processing.

Forms