According to the Biocidal Products Regulation (BPR), product dossiers for existing products must be submitted at the latest by the date of approval of the respective active substance(s) contained in the product. If this requirement is not met, the products lose their marketing licence for the European market. The exact dates by which product dossiers must be submitted are provided in the active-substance-specific implementing regulations.
We help you define the appropriate dossier strategy:
- Is the biocidal product family concept applicable?
- Is Union authorisation or a mutual recognition application more suitable?
- Which member state should be approached for the role of the reference member state?
We support you throughout the compilation of your dossier, from the initial preparatory work through to submission:
- Review of available data on your biocidal product: Are there any gaps in the data? Is read-across or a non-submission justification possible?
- Planning and monitoring of required product studies
- Identification of substances of concern and definition of necessary regulatory activities
- Definition of intended uses
- Performance of exposure and risk assessments for human health, animal health and the environment
- Identification of possible critical issues and clarification of a way forward with the selected reference member state in a pre-submission meeting
- Preparation of the dossier (product assessment report, IUCLID file and SPC document)
- Dossier submission via R4BP3
Follow-up & defence
We assist you in the defence of your dossier:
- Timely and competent response to questions raised by the authorities
- Representation and support of the applicant in ECHA working group meetings in Union authorisation cases
Biocidal product consortia
SCC GmbH helps consortia of interested companies obtain joint authorisation for biocidal products. For more information, please refer to our website on biocidal product consortia management.
We provide tailor-made solutions to offer the exact level of support that you need: Whether you require assistance with a few specific questions or want us to take overall responsibility for the preparation of entire product dossiers.
Don’t hesitate to contact us to discuss the best solution for your biocidal product dossier.