New Product Submission Checklist - Autogenous Vaccines

Documents to be Submitted by the Manufacturer

#	Name of product	Canadian origin	United States (US) origin	Check () to confirm inclusion
1.	Cover letter introducing submission and identifying regulatory contact
2.	Application for Services (Form CFIA/ACIA 4720) and applicable fees
3.	Veterinary Biologics Information (Form CFIA/ACIA 1503)	original	original
4.	Copy of US Veterinary Biological 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 correspondance 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

#	Name of product	Canadian origin	United States (US) origin	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