Renewal of active substance approval
The process of active substance renewal is described in the EU implementing regulation no. 844/2012. A lot of administrative issues are described in the EFSA administrative guidance. The process has a lot of similarities with the process for active substance approval. Therefore, the most important differences are stated here.
Time lines for the submission of the renewal application and the dossier and the assessment procedure do differ from the timelines for Active substance approval.
Timeline Renewal active substance
In this scheme the simplified timelines for submission of application and supplementary dossier and the assessment process of the renewal of an active substance are drawn up. This timeline has been amended (Reg (EU) no 2020/103). Consequently, the timeline for the applications for renewal of active substances that expire before 13 May 2023 (Lower one in the scheme) differs from the timeline of the renewal process of active substances expiring after 13 May 2023 (timeline on top of the scheme).
From 27 March 2021 onwards the Transparency Regulation will be applicable to all applications for active substances and MRL’s. The text on this website is not (fully) adapted to the new situation. Please visit our page on the Transparency Regulation and EFSA for more information about the consequences.