Earlier this year, ECHA has announced that several applications for Union Authorisation (UA) have been submitted without a prior pre-submission consultation, a legal requirement according to BPR Annex III, point 2. Prospective applicants for UA application should submit a pre-submission application through R4BP (UP-APP), at the latest 6 months before the intended date of UA submission. A draft SPC for the relevant biocidal product/family together with the relevant supporting documents will be necessary to confirm that the product falls within the scope of BPR. The aim of this pre-submission application is to confirm that the product will have similar conditions of use across the Union. This is not the same as pre-submission meetings with your evaluating CA or the reference MS in the context of BPF or PA dossier, which are strongly recommended but not legally binding.
If you need regulatory support for biocides please contact Kerona’s expert team at email@example.com or call our office at +3530(0)1 849 5284