Prior to submission of your application, you need to
- contact the evaluating competent authority (eCA) you wish to evaluate your application. Their written confirmation must be included in the application.
- Have all EU member states confirm that the conditions of use are similar across the Union. For details see Instructions for submission.
Prior to submission, it is possible to get support from Ctgb via the Service Desk in case you have specific questions about your application.
Request for Meeting (RFM)
Once during the preparation of your dossier, at any stage of dossier preparation you prefer, Ctgb can offer you a meeting to discuss the set-up of your dossier or any problems you run into.
After submission of your application, ECHA will perform a check of the dossier. A fee needs to be paid. The application will then be transferred to the eCA. The eCA will send you an invoice for the application, validate your application. When the application is found to be complete, the evaluation will be started. The applicantwill have the opportunity to comment on the draft assessment report, the eCA will send the draft assessment report to ECHA, which will prepare a Biocidal products Committee (BPC) opinion for approval by the BPC and finally by the Commission.
More information about the procedure can be read on the ECHA website in the BPC Working procedure for Union authorisation applications.
Timelines for of applications for Union authorisations are described in the BPR Art. 43 and 44 and explained on the ECHA website for both submission and evaluation.
- as for national applications, difference: after 365 days the eCA send the assessment report and conclusions to ECHA
- Within 180 days after receipt of the conclusions, ECHA prepares an opinion and sends it to the Commission.
- Within 30 days after sending the opinion to the Commission, ECHA sends the draft SPC to the Commission.
- Commission takes a decision (no timeline given in BPR)