VB product submission checklist – Autogenous vaccines
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No. | Documentation requirement | Canadian applicant | US 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 | Required | Required | |
02. | Veterinary Biologics information - Form CFIA/ACIA 1503 | Required | Required | |
03. | Copy of US Veterinary Biologics Establishment license, if not previously filed with the CCVB Copy of US Veterinary Biologics Product License |
N/A | Required | |
04. | 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 | |
05. | Bilingual generic draft or final labels and inserts (If applicable) Photocopies of labels and inserts approved by USDA-CVB |
Required | Required | |
06. | Declaration of Compliance regarding TSE Material of Animal Origin (MAO) Special Outline |
Required | Required | |
07. | Master cell stock(s): purity, safety and identity | If applicable | If applicable | |
08. | Adjuvant safety data to support withdrawal claim | If applicable | If applicable | |
09. | Template of Manufacturer's Serial Release Test Report to CCVB. | Required | Required | |
10. | Copies of all correspondence with USDA-CVB | N/A | Required | |
11. | Other supporting documentation (identify) | If applicable | If applicable |
Documents to be Submitted by the attending veterinarian
No. | Documentation requirement | Canadian autogenous vaccine manufacturer | US autogenous vaccine manufacturer | File or document name, version and date (yyyymmdd), if applicable |
---|---|---|---|---|
12. | Application for Permit To Import Veterinary Biologics into Canada - Form CFIA/ACIA 1493 | N/A | Required; submit to CCVB | |
13. | Information Required for Prescription Platform Product and Autogenous Veterinary Biologics – Form CFIA/ACIA 5569 | Required: submit to the Canadian manufacturer | Required; submit to CCVB | |
14. | Diagnostic laboratory report identifying the causative organism(s) | Required; submit to the Canadian manufacturer | Required; submit to CCVB |
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