New Product Submission Checklist - Autogenous Vaccines
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Documents to be Submitted by the Manufacturer
| No. | Name of product | Origin | ||
|---|---|---|---|---|
| Canada (CAN) | United States (US) | Check (Check) to confirm inclusion |
||
| 1. | Cover letter introducing submission and identifying regulatory contact | R | R | |
| 2. | Application for Services (Form CFIA/ACIA 4720) and applicable fees | R | R | |
| 3. | Veterinary Biologics Information (Form CFIA/ACIA 1503) | original | original | |
| 4. | Copy of US Veterinary Biologics Establishment License | N/A | 1 copy | |
| 5. | Copy of US Veterinary Biological Product License | N/A | 1 copy | |
| 6. | Outline of Production (OP) [Note: specific OP or Special Outline (SO) required for autogenous viral vaccine] | 2 copies | 1 copy (2 for viral) | |
| 7(A). | All related OP's, if applicable | 2 copies | 1 copy | |
| 7(B). | All referenced SO and SOPs if not already on file at CCVB | 2 copies | 1 copy | |
| 8(A). | Draft generic or final labels (and inserts if applicable) | 2 copies | 2 copies | |
| 8(B). | Photocopies of labels and inserts approved by USDA-CVB | N/A | 1 copy | |
| 9(A). | Material of Animal Origin (MAO) - SO | 2 copies | 1 copy | |
| 9(B). | MAO - Supplier documents | 1 copy | 1 copy | |
| 10. | Declaration of Compliance regarding TSE | original | original | |
| 11. | Data on master cell stock(s): purity, identity etc. | 1 copy | 1 copy | |
| 12. | Validation data on materials and methods used for inactivation | 1 copy | 1 copy | |
| 13. | Adjuvant safety data to support withdrawal claim | 1 copy | 1 copy | |
| 14. | Sample copy of Manufacturer's Serial Release Test Report | 2 copies | N/A | |
| 15. | Copies of all correspondence with USDA-CVB | N/A | 1 copy | |
| 16. | Facility and personnel documents | N/A | 1 copy | |
| 17. | Latest inspection report of USDA-CVB | N/A | 1 copy | |
| 18. | Additional supporting documents (please identify) | as applicable | as applicable | |
Documents to be Submitted by the Attending Veterinarian
| No. | Name of product | Origin | ||
|---|---|---|---|---|
| Canada (CAN) | United States (US) | Check (Check) to confirm inclusion |
||
| 19(A). | Application for Permit to Import Veterinary Biologic into Canada (Form CFIA/ACIA 1493) | N/A | original | |
| 19(B). | CFIA-CCVB Form for submitting the required information and justification for using the autogenous biologic | submit to manufacturer | original | |
| 19(C). | Laboratory report identifying the causative organism(s) | submit to manufacturer | 1 copy | |
| 19(D). | Application for Services (Form CFIA/ACIA 4720) with fees | N/A | R | |
Legend
N/A: Not Applicable
R: Required
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