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VB product submission checklist – For further manufacture (FFM)

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 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

Copy of US Veterinary Biologics Establishment License, Manufacturing Authorization, or equivalent from country of origin, if not previously submitted to the CCVB

Copy of Authorization or permission to manufacture FFM Product in country of origin

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
06. Bilingual draft or final labels to be used for FFM product shipment Required Required

Declaration of Compliance regarding TSE

Material of Animal Origin (MAO) Special Outline

Required Required

Master seed(s): purity, safety and identity

(If applicable) Genetic characterization data for biotechnology derived product

Required Required
09. Master cell stock(s): purity, safety and identity If applicable If applicable
10. Template of required tests and specifications, including antigenic content, of acceptable bulk product for further manufacture, or Summary of Bulk Product Characteristics Required Required
11. Other supporting documentation (identify) If applicable If applicable
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