This document outlines the timeline and key steps involved in obtaining biocide authorization, which can take up to 30 months to complete: 1) An initial data gap analysis is conducted to structure the product family, identify existing data, and determine what additional testing may be required. 2) Dossier preparation involves completing Iuclid datasets for the active substance and products, drafting supporting documents like exposure scenarios, and finalizing the dossier for submission via R4BP. 3) Translation of dossier documents may be required for mutual recognition applications in other countries in parallel to the primary authorization process.

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