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VB product submission checklist – Autogenous vaccines

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No. Documentation requirement Canadian applicant US
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

Copy of US Veterinary Biologics Establishment license, if not previously filed with the CCVB

Copy of US Veterinary Biologics Product License

N/A Required

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

Bilingual generic draft or final labels and inserts

(If applicable) Photocopies of labels and inserts approved by USDA-CVB

Required Required

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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