Instructions for submission

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.

Pre-submission

Before submission, you need to do a pre-submission to check whether the conditions of use are similar across the Union. Hereto, all member states will check your draft SPC and confirm the possible use of your product in their countries. Additionally, there may be a pre-submission meeting (usually teleconference) with ECHA and the eCA. The application for a pre-submission needs to be done via R4BP. More details can be found on the ECHA website.

Submission

Submissions must be done via R4BP. Instructions are given in ECHA’s Biocides Submission Manual on using R4BP.

The application must refer to the product dossier in IUCLID and must include a draft Product Assessment Report (PAR) in Word format (see ECHA formats and templates) and a Summary of Product Characteristics (SPC) in i6z format (preparation in IUCLID). Additionally, if applicable, Ctgb requires an overview of the product family structure (download the open standard file and open with Excel). Please note there are different SPC templates available either for single products or for biocidal product families.

On the ECHA website also instructions and manual on Union authorisations are available. All documents should be in English.