VB product submission checklist – Export only

No. Documentation requirement Canadian applicant File or document name, version and date (yyyymmdd), if applicable
00. Index of submission contents Required

Cover letter introducing the licensing submission and identifying regulatory contact

Official document from the regulatory authorities of the importing country indicating consideration or acceptance of the product

02. Veterinary Biologics information - Form CFIA/ACIA 1503 Required

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


Draft or final labels for each importing country

(If applicable) Certified translation in English or French of the foreign language labels to be used in the importing country or countries


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
07. Master cell stock(s): purity, safety and identity If applicable
08. Efficacy: laboratory data and proof of concept or, for a diagnostic kit, data on laboratory performance Required
09. Safety: laboratory and containment safety studies Required

Other supporting documentation (identify)

(Live or biotechnology products) Environmental assessment

If applicable