Dossier submission for union authorisation

Applications are submitted through R4BP 3 in the form of a IUCLID file.

This graph shows an overview of the dossier submission process. 

Steps

Authorisation proceeds in several steps. Each step needs to be completed before the application can move to the next step. It is important that the applicant makes sure that all relevant deadlines are met, otherwise the application will be rejected during the course of the process.

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ECHA checks that the application and data have been submitted in the correct format.

 
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The applicant pays the related fees to ECHA within 30 days from the invoice date.

 
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ECHA accepts the application and the evaluating competent authority has 30 days to validate the application (completeness check).

 
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The applicant pays the related fees to the evaluating competent authority within 30 days.

 
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If the dossier is deemed to be incomplete, the evaluating competent authority will ask for the missing information and the applicant will have 90 days to provide it.

 
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Evaulation of the dossier starts

 

Actors

The main actors in the dossier submission process are:

Applicants

Applicants are responsible for the quality of the data in their dossiers. They need to provide information about their biocidal product either in the form of a dossier or letter of access. If requested by the evaluating competent authority, they need to provide additional information within the set deadlines. Applicants also need to submit a draft summary of biocidal product characteristics and either a dossier or a letter of access on each active substance contained in the biocidal product.

ECHA

ECHA is responsible for ensuring that the information in the dossiers is in a correct format. ECHA also makes sure that the submission process proceeds within the set timelines.

Evaluating competent authority

The evaluating competent authority is responsible for carrying out the validation of the application dossiers and for the evaluation of the dossier submitted by the applicant.

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