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 | |
04. | 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 | |
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 to be used for FFM product shipment | 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 |
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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