New Product Submission Checklist - Diagnostic Kits

[Date: yyyy-mm-dd]

No.	Name of product:	Canadian origin	United States (US) origin	Other countries 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
4.	Application for Permit To Import Veterinary Biologic into Canada - Form CFIA/ACIA 1493	N/A
5.	Copy of Veterinary Biological Establishment License, Manufacturing Authorization, or equivalent	N/A
6.	Copy of Veterinary Biological Product License, Marketing Authorization, or equivalent	N/A
7.	Justification for use of veterinary biologic in Canada
8.	Outline of Production (OP) *S of C = Summary of Changes	3 copies	1 copy + APHIS 2015 and S of C*	3 copies
9(A).	Related Outlines of Production	3 copies of each	1 of each	3 copies of each
9(B).	Referenced Special Outlines (SO) and SOPs (if not already on file at CCVB)	3 of each if new	1 of each if new	3 of each if new
9(C).	Validation data referenced in OP including data for reference standards and antigen inactivation
10(A).	Draft or final labels	4 copies of each including insert	4 copies of each including insert	4 copies of each including insert
10(B).	Photocopies of approved labels in the country-of-manufacture for reference only	N/A
10(C).	Summary of Product Characteristics	N/A	N/A
11(A).	Material of Animal Origin (MAO) - SO	3 copies	1 copy (US) 3 copies (Cnd)	3 copies
11(B).	MAO - Supplier documents	1 copy	1 copy	1 copy
12.	Declaration of Compliance regarding TSE (original)
13.	Antigen in the kit
13(A).	Master seed(s): purity and identity
13(B).	Genetic characterization data if biotechnology-derived product
14.	Master cell stock(s): purity and identity
14(A).	Cell lines(s) for viral antigen(s)
14(B).	Hybridomas for monoclonal antibodies
15.	Efficacy/ Performance
15(A).	(A) Preliminary data and proof of concept		N/A
15(B-1).	Protocol(s) on reproducibility (Potency)
15(B-2).	Report(s) - Data on reproducibility	Pending: tiered review		Pending: tiered review
15)C-1).	Protocol(s) on repeatability
15(C-2).	Report(s) - Data on repeatability	Pending: tiered review		Pending: tiered review
15(D-1).	Protocol(s) on field performance
15(D-2).	Report(s) of field performance from different laboratories	Pending: tiered review		Pending: tiered review
15(D-3).	Summary report of field performance from the manufacturer	Pending: tiered review		Pending: tiered review
15(E).	Estimates of specificity and sensitivity
15(F).	Copies of related correspondence with regulatory authorities of country of origin	N/A
16(A).	Non cross-reactivity data
16(B).	Copies of related correspondence with regulatory authorities of country of origin	N/A
17.	Guidance on laboratory bio-safety, handling and disposal
18(A).	Stability data to support expiry date
18(B).	Copies of related correspondence with regulatory authorities of country of origin	N/A
19.	Environmental assessment	If applicable	If applicable	If applicable
20.	Template of Manufacturer's Serial Release Test Report Form to CCVB (3 copies)		N/A
21	Results on 3 pre-licensing serials
22.	Other supporting documentation (identify)	If applicable	If applicable	If applicable