Submission of an application dossier

The dossier

The application dossier must be drawn up in accordance with a package system. For applications for a new authorisation, the following packages need to be sent:

  1. administration
  2. physico-chemistry
  3. toxicology
  4. residues
  5. behaviour in the environment
  6. ecotoxicology
  7. efficacy
  8. First Aid

You can find our address at our contact page. Correspondence must also contain an accompanying letter with information about the application addressed to the dossier manager.

Upon reception of these packages, an invoice will be drawn up which will indicate the reference number attributed to the dossier (dossier number or N-number).

The presentation in packages must also be taken into account:

  • for the completion of a dossier (the subsequent supply of additional data during the course of the assessment process)
  • for applications regarding pre-existing authorisations.

In these cases, the N-number, which is always unchanged for the same formulation, is already known and the applicant can immediately send all packages with a clear indication of this N-number. Naturally, a given package is only necessary if there are underlying data that need to be assessed by the relevant expert. For example, for applications for existing authorisations, such as an application for an extension, usually no package of physico-chemistry or toxicology will be necessary.

In order to simplify the procedure, the following practical observations apply:

  • limit the number of sent items per application (preferably all packages together for the same address),
  • one type of application and one product per dispatch in order to keep procedures separate.

You can find additional details regarding our administrative requirements for the various types of dossiers in our manual.

The commercial name

There are a number of conditions with which the commercial name must comply. You can find the general rules in our manual.

The label

The proposal for the label must be submitted in at least 2 languages (Dutch and French). However, the label will not be approved by the Authorisation Committee: the authorisation holder bears responsibility for the label, which must correspond with the approved authorisation certificate. You can find more information regarding the obligations and restrictions relating to the label in our manual.

First Aid

You can find the instructions for drawing up the instructions for First Aid here.

Letter of access

In order to refer to the protected data from other authorisation holders for the authorisation of a product, a letter of access is required. You can find more information regarding letters of access in our manual.