VB product submission checklist – Vaccines, immunomodulators, and prescription products
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|No.||Documentation requirement||Canadian applicant||US or foreign applicant||File or document name, version and date (yyyymmdd), if applicable|
|00.||Index of submission contents||Required||Required|
Cover letter introducing the licensing submission and identifying regulatory contact
Justification for use of VB in Canada
|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|
Copy of US Veterinary Biologics Establishment License, Manufacturing Authorization, or equivalent from country of origin
Copy of Authorization or permission to manufacture VB Product in country of origin
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 product inactivation
|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|
Declaration of Compliance regarding TSE
Material of Animal Origin (MAO) Special Outline
Master seed(s): purity, safety and identity
(If applicable) Genetic characterization data for biotechnology derived product
(If applicable) Virucidal and bactericidal data
(If applicable) Bluetongue virus testing
(If applicable) Pseudorabies (Aujesky's disease) virus testing
|09.||Master cell stock(s): purity, safety and identity||If applicable||If applicable|
|10.||Efficacy: preliminary data and proof of concept; protocols, final reports, and related correspondence with regulatory authorities of country of origin||Required||Required|
|11.||Non-interference: Data and related correspondence with regulatory authorities of country of origin||If applicable||If applicable|
Safety: laboratory and containment safety studies; field safety study protocols, final reports.
(Live or biotechnology products) Data on genetic stability/non-reversion to virulence; safety in non-target species; human safety
(Novel adjuvant) Adjuvant safety
All safety-related correspondence with regulatory authorities of country of origin.
|13.||Potency: data to support measurements of product strength, and related correspondence with regulatory authorities of country of origin||Required||Required|
|14.||Stability: data to support expiry date, and related correspondence with regulatory authorities of country of origin||Required||Required|
Test results on 3 pre-licensing serials.
(If applicable) Template of Manufacturer's Serial Release Test Report to CCVB.
|16.||(Live or biotechnology products) Environmental Assessment for Canada and (if applicable) copy of USDA-CVB-filed Summary Information Format||If applicable||If applicable|
|17.||Other supporting documentation (identify)||If applicable||If applicable|
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