VB product submission checklist – Diagnostic kits

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No.	Documentation requirement	Canadian applicant	US or foreign applicant
00.	Index of submission contents	Required	Required
01.	Cover letter introducing the licensing submission and identifying regulatory contact Justification for use of VB in Canada	Required	Required
02.	Veterinary Biologics information - Form CFIA/ACIA 1503	Required	Required
03.	Application for permit to import Veterinary Biologics into Canada - Form CFIA/ACIA 1493	N/A	Required
04.	Copy of US Veterinary Biologics Establishment License, Manufacturing Authorization, or equivalent from country of origin, if not previously filed with the CCVB Copy of US Veterinary Biologics Product License, Authorization or permission to manufacture diagnostic kit in country of origin	N/A	Required
05.	Outline of Production (OP) for the VB (If applicable) Referenced OP, Special Outlines (SO) and SOPs, if a current version is not on file with the CCVB. (If applicable) Validation data referenced in OP including data for reference standards and antigen inactivation	Required	Required
06.	Bilingual draft or final labels (If applicable) Photocopies of approved labels in the country-of-manufacture	Required	Required
07.	Declaration of Compliance regarding TSE Material of Animal Origin (MAO) Special Outline	Required	Required
08.	Antigen and/or antibody Master seed(s): purity and identity; genetic characterization data if derived from biotechnology Cell line(s) for viral antigen(s) Hybridomas for monoclonal antibodies	If applicable	If applicable
09.	Efficacy and kit performance: preliminary data and proof of concept; protocols and final reports on reproducibility (potency), repeatability, field performance, estimates of specificity and sensitivity Copies of correspondence with regulatory authorities of country of origin	Required	Required
10.	Non-cross-reactivity: Data and related correspondence with regulatory authorities of country of origin	Required	Required
11.	Safety: laboratory biosafety studies, handling and disposal	Required	Required
12.	Stability: data to support expiry date, and related correspondence with regulatory authorities of country of origin	Required	Required
13.	Environmental Assessment	If applicable	If applicable
14.	Test results on 3 pre-licensing serials (If applicable) Template of Manufacturer's Serial Release Test Report to CCVB	Required	Required
15.	Other supporting documentation (identify)	If applicable	If applicable

Date modified:: 2023-02-15