VB product submission checklist – Allergenic extracts, serum, or plasma products
| 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 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 Veterinary Biologics Establishment License, if not previously filed with the CCVB Copy of Veterinary Biologics Product License |
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 (If applicable) Photocopies of approved labels in the country-of-manufacture (If applicable) Allergenic extracts: dosage and administration schedule |
Required | Required | |
| 07. | Declaration of Compliance regarding TSE Material of Animal Origin (MAO) Special Outline |
Required | Required | |
| 08. | Antigen for hyperimmunization /desensitization Master seed(s): purity, safety and identity Master cell stock(s): purity, safety and identity |
If applicable | If applicable | |
| 09. | Animal donor information: pre-qualification testing, vaccination, prevention/treatment for parasites, etc. Schedule of collection from donor animals |
If applicable | If applicable | |
| 10. | Efficacy: preliminary data and proof of concept; protocols, final reports, and related correspondence with regulatory authorities of country of origin | If applicable | If applicable | |
| 11. | Safety: laboratory and containment safety studies; field safety study protocol, final report, and related correspondence with regulatory authorities of country of origin | Required | Required | |
| 12. | Potency: data to support antibody content or product strength, and related correspondence with regulatory authorities of country of origin | Required | Required | |
| 13. | Stability: data to support expiry date, and related correspondence with regulatory authorities of country of origin | Required | Required | |
| 14. | Quality control test results on 3 pre-licensing serials | Required | Required | |
| 15. | Other supporting documentation (identify) | If applicable | If applicable |
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