- Biocidal Products Regulation
- Authorisation of biocidal products
- National authorisation and mutual recognition renewal
- Dossier submission
The national authorisation renewal applications, including those subject to or granted through mutual recognition, are submitted through R4BP 3. An IUCLID file may be required in certain conditions as described in the industry submission manual 4a.
This graphic shows an overview of the dossier submission process.
The national authorisation renewal 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.
ECHA checks that the application and data have been submitted in the correct format.
The competent authority of the receiving Member State and, in case of mutual recognition, the reference MSCA and all the concerned MSCAs, inform the applicant on the payable fees. The applicant pays the related fees to the MSCA(s) within 30 days from the invoice date. The application is formally accepted.
If the dossier is deemed to be incomplete, the reference or the receiving MSCA will ask for the missing information and the applicant will have a reasonable period (normally not exceeding 90 days) to provide it.
Within 30 days of the acceptance, or within 30 days from the date the requested additional information was received, the receiving or reference Member State shall validate the application.*
Evaluation of the dossier starts
The main actors in the dossier submission process are:
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 MSCA, they need to provide additional information within the set deadlines. Applicants also need to submit a draft summary of biocidal product characteristics.
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.
The receiving competent authority is responsible for carrying out the evaluation of the dossier submitted by the applicant in case of national authorisation renewal.
The reference competent authority is responsible for carrying out the validation of the application dossiers and for the evaluation of the dossier submitted by the applicant in case of mutual recognition renewal. It can be a different MSCA than the one that evaluated the original authorisation (upon agreement).
The concerned competent authorities are responsible for verifying that the application received for the renewal of the mutually recognised authorisation falls within the scope of the supplementary rules (as per Article 1(2) and (3) of Regulation (EU) No 492/2014).
*For mutual recognition renewal within 30 days of the acceptance the concerned Member State(s) will verify that the application it has received falls within the scope of the supplementary rules for renewal as per Article 1(2) and (3) of Commission Delegated Regulation (EU) No 492/2014 (i.e. authorisations granted subject to the same terms and conditions, subject to limited exceptions such as information which can be the subject of an administrative change). If not, the application for renewal must be processed under the regular renewal procedures set out in Article 31 of the BPR.