Instruction for Submission
Technical guides, application instructions and process manuals can be found on the ECHA website. Particularly useful is ECHA’s Practical guide on Renewal of an approval of active substance.
Before submission of your application, you must approach the evaluating competent authority you wish to evaluate your application, and ask them for a written agreement. The agreement needs to be included in your application.
If you wish The Netherlands (Ctgb) to act as eCA, please contact Cindy van der Meer.
Pre-submission meeting (PSM)
At any stage of the preparation of your dossier, Ctgb can offer you a meeting to discuss the set-up of your dossier or any problems you run into. For details, see our information on Pre Application Support.
Submission must be done via R4BP. Instructions are given in ECHA’s Manual on using R4BP. The application must refer to the active substance dossier in IUCLID and must include a draft Assessment Report in Word format. Instructions can be found on the ECHA website. All documents should be in English.