| 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 | |
| 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 |