Estimates for the year 2018 03 Argumentation for estimated no. of submissions for UA based on the progress of the Review Programme in 2018 Active substances PTs Results from MSCA data on No. of markets the Results from our survey and Drop out rate Ratio BP/BPF based Estimates 2018 with deadline in registered BPs product is on according AISE/EBPF survey on based on on surveys 2018 to the MSCA data appropriateness of the PT the AS surveys falls under for UA 2, 3 Only in France, 4 under PT02 1 out of 19 markets For all PTs falling under main group 25% A high percentage of 0 0 0 and 8 under PT03. 1, UA is perceived as a valid products will be placed alternative to NA+MR. on the market under Calcium oxide / lime / BPFs rather than as burnt lime / quicklime separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 2, 3 Only in France, 13 BPs in total 1 out of 19 markets For all PTs falling under main group 25% A high percentage of 0 0 0 4 PT02, 5 PT02 and 03 and 4 1, UA is perceived as a valid products will be placed Calcium dihydroxide / PT03 alternative to NA+MR. on the market under calcium hydroxide / BPFs rather than as caustic lime / separate products. hydrated lime / slaked According to the lime AISE/EBPF survey 60% of dossiers will be BPF. 2, 3 Only in France 7 BPs 2 out of 19 markets For all PTs falling under main group 25% A high percentage of 0 0 0 PT02 and Germany 1 BP 1, UA is perceived as a valid products will be placed Calcium magnesium under PT03 alternative to NA+MR. on the market under tetrahydroxide / BPFs rather than as calcium magnesium separate products. hydroxide / hydrated According to the dolomitic lime AISE/EBPF survey 60% of dossiers will be BPF.
Estimates for the year 2018 03 Argumentation for estimated no. of submissions for UA based on the progress of the Review Programme in 2018 Active substances with deadline in 2018 PTs Results from MSCA data on registered BPs No. of markets the product is on according to the MSCA data Results from our survey and AISE/EBPF survey on appropriateness of the PT the AS falls under for UA Drop out rate based on surveys Ratio BP/BPF based on surveys Estimates 2018 Calcium oxide / lime / burnt lime / quicklime 2, 3 Only in France, 4 under PT02 and 8 under PT03. 1 out of 19 markets For all PTs falling under main group 1, UA is perceived as a valid alternative to NA+MR. 25% A high percentage of products will be placed on the market under BPFs rather than as separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 0 0 0 Calcium dihydroxide / calcium hydroxide / caustic lime / hydrated lime / slaked lime 2, 3 Only in France, 13 BPs in total 4 PT02, 5 PT02 and 03 and 4 PT03 1 out of 19 markets For all PTs falling under main group 1, UA is perceived as a valid alternative to NA+MR. 25% A high percentage of products will be placed on the market under BPFs rather than as separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 0 0 0 Calcium magnesium tetrahydroxide / calcium magnesium hydroxide / hydrated dolomitic lime 2, 3 Only in France 7 BPs PT02 and Germany 1 BP under PT03 2 out of 19 markets For all PTs falling under main group 1, UA is perceived as a valid alternative to NA+MR. 25% A high percentage of products will be placed on the market under BPFs rather than as separate products. According to the AISE/EBPF survey 60% of dossiers will be BPF. 0 0 0
CA-May16-Doc.7.8%20-%20BPR%20fee%20model%20final%20report.docx