New Product Submission Checklist - Export Only
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[Date: yyyy-mm-dd]
| No. | Name of product: | Canadian origin | Check (Check) to confirm inclusion |
|---|---|---|---|
| 1. | Cover letter introducing submission and identifying regulatory contact | R | |
| 2. | Application for Services - Form CFIA/ACIA 4720 and applicable fees | R | |
| 3. | Veterinary Biologics Information - Form CFIA/ACIA 1503 | R | |
| 4. | Official document from the regulatory authorities of the importing country indicating acceptance of the product | R | |
| 5. | Outline of Production (OP) | 2 copies | |
| 6(A). | Related Outlines of Production | 2 copies of each | |
| 6(B). | Referenced Special Outlines (SO) and SOPs (if not already on file at CCVB) | 2 of each if new | |
| 6(C). | Validation data referenced in OP including data for reference standards and product inactivation | R | |
| 7(A). | Draft or final labels for each importing country | 2 copies of each, including insert | |
| 7(B). | Certified translation in English or French of the labels in foreign language(s) used in the importing country(ies) | R | |
| 8(A). | Material of Animal Origin (MAO) - SO | 2 copies | |
| 8(B). | MAO - Supplier documents | 1 copy | |
| 9. | Declaration of Compliance regarding TSE (original) | R | |
| 10(A). | Vaccines - Master seed(s): purity, safety and identity | R | |
| 10(B). | Genetic characterization data if biotechnology-derived product (vaccines) | R | |
| 11. | Vaccines - Master cell stock(s): purity, safety and identity | R | |
| 12. | Vaccines - Proof of efficacy/ immunogenicity data | R | |
| 13. | Vaccines - Laboratory safety data | R | |
| 14. | Diagnostic kits - Data on laboratory performance | R | |
| 15. | Other supporting documentation (identify) | If applicable |
Legend
R: Required
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