The preparation of an application dossier for a Biocidal Product Family (BPF) can be a big challenge depending on the number of biocidal products, co-formulants, PTs claimed and intended uses to be included. As you might know, a Working Party (WP) has been set up to clarify certain aspects of the BPF concept and to support the updating of the Note for Guidance “Implementing the new concept of biocidal product families” dated from November 2014. The issue of ‘similarity’ was one of the WP objectives in addition to provide the Commission with recommendations allowing applicants to submit more robust BPF application dossiers.
Key aspects covered:
An understanding of the BPF concept is necessary to allow applicants limiting as far as possible the resources and time required to prepare those applications. Are you a prospective authorisation holder for a BPF facing the upcoming Note for Guidance on BPF and/or uncertainties and ongoing discussions concerning splitting and restructuring the families on BPR level?
Then, this event offers you an overview of the new BPF concept and focuses on the following aspects:
- Similarity of uses
- Similarity of composition and grouping of co-formulants
- Similar levels of risk and efficacy
- Best practices for BPF pre-submission meetings
- Splitting of families for ongoing applications
Nathalie Hanon and Cyril Durou (CEHTRA) will drive you through the BPF concept and the steps necessary for grouping biocidal products into a BPF and the challenges to be faced when applying this new BPF concept according to the latest regulatory guidance and regulations.