| 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 Copy of Authorization or permission to manufacture VB 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 and product inactivation |
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. | 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 |
Required | Required | |
| 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 | |
| 12. | 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. |
Required | Required | |
| 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 | |
| 15. | Test results on 3 pre-licensing serials. (If applicable) Template of Manufacturer's Serial Release Test Report to CCVB. |
Required | Required | |
| 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 |