VB product submission checklist – Antibody products

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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 authorization or permission to manufacture antibody product 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	Required	Required
06.	Bilingual draft or final labels (If applicable) Photocopies of approved labels in the country-of-manufacture (If applicable) Summary of Product Characteristics	Required	Required
07.	Declaration of Compliance regarding TSE Material of Animal Origin (MAO) Special Outline	Required	Required
08.	Antigen for hyperimmunization Application for permit to release unlicensed vaccine (Canada only) Master seed(s): purity, safety and identity Master cell stock(s): purity, safety and identity	If applicable	If applicable
09.	Efficacy: preliminary data and proof of concept; protocols, final reports, and related correspondence with regulatory authorities of country of origin	Required	Required
10.	Non-interference: Data and related correspondence with regulatory authorities of country of origin	If applicable	If applicable
11.	Safety: laboratory and containment safety studies; field safety study protocols, final reports All safety-related correspondence with regulatory authorities of country of origin	Required	Required
12.	Potency: data to support antibody content or product strength, and related correspondence with regulatory authorities of country of origin	Required	Required
13.	Stability: data to support expiry date, and related correspondence with regulatory authorities of country of origin	Required	Required
14.	Environmental Assessment	If applicable	If applicable
15.	Test results on 3 pre-licensing serials (If applicable) Template of Manufacturer's Serial Release Test Report to CCVB	Required	Required
16.	Other supporting documentation (identify)	If applicable	If applicable

Date modified:: 2023-02-15