EUROPE-EFSA: Guidance on active substance applications for approbation and renewal

EFSA published a technical report to describes  the administrative requirements for the preparation  and submission of the dossier to support an application  for the approval, the amendment of approval or the renewal  of an existing approval of a pesticide active substance.

The  procedure  and the associated  timelines for handling  applications for approval,  from their submission to the adoption and publication of the EFSA conclusion are also described.

This document also provides additional guidance with the aim to enhance the quality of dossiers and assessment  reports. It provides instructions, guidance and templates for both the applicant and Rapporteur Member  State on how data should be presented in the dossier and in the assessment report.

The  document finally presents  the different possibilities applicants  have to interact with EFSA staff under this peer review process and the support initiatives available during the different stages of the application life-cycle.

To download:

Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances

Lynxee consulting’s team is at your disposal to answer your questions.

Contact us! https://lynxee.consulting/en/contact/