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:

eCA agreement

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.

Request for Meeting (RFM)

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

Submission must be done via R4BP3. Instructions are given in ECHA’s Manual on using R4BP3. 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.