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 (checkmark)
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 (checkmark)
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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