The application procedure for simplified authorisation of a biocidal product is similar to the procedure for national product authorisation except for the different data requirements. Applicants need to submit a draft summary of biocidal product characteristics, relevant efficacy data and any other relevant information demonstrating that the product meets the conditions for a simplified authorisation procedure.
Applications are submitted through R4BP 3 to ECHA in the form of a IUCLID file.
This graph shows an overview of the application procedure for simplified authorisation.
The process has 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.
ECHA checks that the application and data have been submitted in the correct format and informs the evaluating competent authority through R4BP 3.
The applicant pays the related fees to evaluating competent authority within 30 days from the invoice date and the evaluating competent authority accepts the application.
The evaluating competent authority has 90 days to assess the dossier and to authorise the placing of the product on the market.
If the dossier is incomplete, the evaluating competent authority will ask for the missing information from the applicant. This should normally be provided within 90 days. In this case, the evaluating competent authority shall authorise the product within 90 days of receiving the additional information.
A biocidal product authorised according to the simplified authorisation procedure in one Member State can be placed on the market of other Member States without the need for mutual recognition.
Nevertheless, the authorisation holder must notify all the concerned Member State competent authorities at least 30 days before placing the product on the market.
If another Member State disagrees on whether the biocidal product meets the criteria for simplified authorisation or considers that it has not been notified or labelled correctly, it may refer the matter to the coordination group to be resolved.