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 | |
01. | 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 |
Required | |
02. | Veterinary Biologics information - Form CFIA/ACIA 1503 | Required | |
03. | 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 |
Required | |
04. | 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 |
Required | |
05. | Declaration of Compliance regarding TSE Material of Animal Origin (MAO) Special Outline |
Required | |
06. | 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 | |
10. | Other supporting documentation (identify) (Live or biotechnology products) Environmental assessment |
If applicable |
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