Registration process

The application for renewal of the active substance approval for a given PT should be submitted to the European Chemicals Agency (ECHA) at the latest 550 days before the expiry date of the approval of the active substance for this PT. If the application relates to more than one PT, it should be made at the latest 550 days before the earliest expiry date.

After receipt of the dossier, the evaluating competent authority (eCA) determines whether a full evaluation of the application is necessary or not. Depending on the outcome, the eCA has 365 days (full evaluation) or 180 days (no full evaluation needed) to complete the evaluation (see timeline – scheme).

AS renewal BPR EM

AS renewal BPR Evaluation Manual