National authorisation evaluation process
Once the receiving MSCA has accepted the application for the renewal of the national authorisation of a biocidal product (or a biocidal product family), the evaluation process starts.
This graphic shows an overview of the dossier evaluation process
The evaluation process for the renewal of national authorisation has the following steps:
The receiving MSCA has 90 days to assess whether a full evaluation of the dossier is required.
The receiving MSCA drafts an assessment report and the conclusions of its evaluation within 365 days of validating the application, where a full evaluation is required. The assessment report includes the reasons for deciding to renew or not, the authorisation.
In case a full evaluation is not needed, the receiving MSCA shall decide on the renewal of the authorisation within 180 days of accepting the application.
If the receiving MSCA considers that additional information is necessary to carry out the evaluation, it can request this from the applicant. The applicant has to provide the requested information within 180 days unless a delay is justified by the nature of the data requested or by exceptional circumstances.
The draft AR is sent to the applicant through R4BP 3 who is provided with the opportunity to submit comments within 30 days. The reference MSCA must take account of any comments from the applicant when finalising the assessment report.
The receiving MSCAs decides on the renewal of the national authorisation
The main actors in the evaluation process are:
Applicants are responsible for providing all necessary information in their dossiers. They should pay attention to the various deadlines throughout the process. Applicants have the possibility to comment the draft assessment report on their dossier during the process.
The receiving MSCA is responsible for carrying out the evaluation of the dossiers submitted by the applicants. It has to assess if a full evaluation of the dossier is needed. In this case the evaluating competent authority has 365 days to evaluate a dossier. It can, however request additional information from the applicant who has a defined number of days to provide it, normally 180 days. The time given to the applicant for providing the additional information extends the 365-day evaluation period.
In case a full evaluation is not needed the receiving MSCA shall decide whether to renew, or not, the authorisation for the product within 180 days from the date of acceptance of the application.