VB product submission checklist – Export only
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|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
|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
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