What happens during a pre-submission meeting?

During a Pre Submission Meeting the applicant receives procedural and substantive advice about the dossier that is to be submitted. ‘Dossier’ is defined as: the entire dossier,  therefore including the draft Registration Report and corresponding studies. The dossier must therefore include the risk assessment. The aim of the PSM is to ensure that the dossier has sufficient quality to proceed smoothly through the application process after submission.

During a PSM, the Ctgb does not conduct any assessments or partial assessments of the dossier, nor does it perform a completeness review. However, an applicant can use a PSM to indicate constraints and to include suggested solutions in his or her dossier.

The general course of affairs during a PSM is as follows:

  • the meeting starts with a plenary component, which includes a discussion of the Legal Conditions for Use and during which you are given the opportunity to make a general presentation focusing on the dossier, such as background, use, substance information, submission strategy and concerned Member States. During this part of the meeting, all assessors of all relevant aspects are present.
  • Subsequently, the meeting continues in a sequential setting; during this part of the meeting, each aspect of the dossier is discussed sequentially with the corresponding assessor. Preceding each aspect discussion, in your presentation you can indicate the constraints in your dossier.
  • Within three weeks after the meeting, you will receive a pre-submission report containing the recommendations for your dossier.

For the time being, a PSM can only be requested preceding the submission of an application for authorisation of a plant protection product.