Instruction for Submission
Technical guides, application instructions and process manuals can be found on the ECHA website. Particularly useful are the 'Practical guide on Approval of active substance' and the 'Biocide Submission Manual Application instructions for active substances'.
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 the account manager 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.
Submission
Submission must be done via R4BP. Instructions are given in ECHA’s Biocides Submission 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.
Note: The only point in time when new information can be added during the peer review is during the Working Group discussions where it can be decided that and if so which specified information will be added. See also: Possibility of introducing new data or new information during the peer review process