VB product submission checklist – Diagnostic kits
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| 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 US Veterinary Biologics Product License, Authorization or permission to manufacture diagnostic kit 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 antigen inactivation |
Required | Required | |
| 06. | Bilingual draft or final labels (If applicable) Photocopies of approved labels in the country-of-manufacture |
Required | Required | |
| 07. | Declaration of Compliance regarding TSE Material of Animal Origin (MAO) Special Outline |
Required | Required | |
| 08. | Antigen and/or antibody Master seed(s): purity and identity; genetic characterization data if derived from biotechnology Cell line(s) for viral antigen(s) Hybridomas for monoclonal antibodies |
If applicable | If applicable | |
| 09. | Efficacy and kit performance: preliminary data and proof of concept; protocols and final reports on reproducibility (potency), repeatability, field performance, estimates of specificity and sensitivity Copies of correspondence with regulatory authorities of country of origin |
Required | Required | |
| 10. | Non-cross-reactivity: Data and related correspondence with regulatory authorities of country of origin | Required | Required | |
| 11. | Safety: laboratory biosafety studies, handling and disposal | Required | Required | |
| 12. | Stability: data to support expiry date, and related correspondence with regulatory authorities of country of origin | Required | Required | |
| 13. | Environmental Assessment | If applicable | If applicable | |
| 14. | Test results on 3 pre-licensing serials (If applicable) Template of Manufacturer's Serial Release Test Report to CCVB |
Required | Required | |
| 15. | Other supporting documentation (identify) | If applicable | If applicable |
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