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Biocide Authorization Timeline
1.
BIOCIDE AUTHORIZATION Timeline Translate SPC files Prepare translated versions
of SPC files (required for mutual recognition in parallel) TIME IN MONTHS DGA Data Gap Analysis (DGA) Structure product family Translate SPC files Risk assessment Dos.Prep / R4BPDossier preparation (Dos. prep.) Structure product family Long term storage stability Other testing Dossier preparation Risk assessment Dos. prep. Translate SPC files 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 R4BP Perform literature search Collate and evaluate existing data (including composition of products, uses, and exisiting study data) Data gap analysis Generate and review AELs and PNECs Development of exposure scenarios Risk assessment preparation Final dossier updates Prepare supporting documents Dossier submission via R4BP Required where a customer wishes to authorize multiple similar products Create product family structure, split into Meta SPC's Propose testing strategy, identify worst case products to test Competent Authority correspondence Complete Iuclid dataset for product including prepartion of robust study summaries, data waivers, C&L, packaging, safe use, composition sections and attach supporting information Complete Iuclid dataset for the active substance, composition and data waivers Prepare dPAR Prepare SPC file (in xml, excel and word formats) Prepare PBT / vPvB assessment Covance is the drug, medical device and diagnostics business segment of LabCorp, a leading global life sciences company. COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world. The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440 Europe/Africa +00.800.2682.2682 +44.1423.500888 Asia Pacific +800.6568.3000+65.6.5686588 © Copyright 2019 Covance Inc. INFCPC001-1019
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