New Product Submission Checklist - Vaccines

[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 product 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.	Material of Animal Origin (MAO) - SO	3 copies	1 copy (US) 3 copies (Cnd)	3 copies
11.	MAO - Supplier documents	1 copy	1 copy	1 copy
12.	Declaration of Compliance regarding TSE (original)
13(A).	Master seed(s): purity, safety and identity
13(B).	Genetic characterization data if biotechnology derived product
14.	Master cell stock(s): purity, safety and identity
15.	Efficacy/ Immunogenicity
15(A).	Preliminary data and proof of concept		N/A
15(B).	Protocol(s)
15(C).	Report(s)	Pending: tiered review		Pending: tiered review
15(D).	Copies of related correspondence with regulatory authorities of country of origin	N/A
16(A).	Non interference data, if applicable
16(B).	Copies of related correspondence with regulatory authorities of country of origin	N/A
17.	Safety
17(A).	Data on genetic stability/non-reversion to virulence (live or biotechnology products)
17(B).	Laboratory and containment safety studies
17(C).	Protocol(s) for field safety studies
17(D).	Report(s) for field safety studies	Pending: tiered review		Pending: tiered review
17(E).	Non target species (if applicable)
17(F).	Human safety (including food safety)
17(G).	Adjuvant safety, if novel
17(H).	Copies of related correspondence with regulatory authorities of country of origin
18(A).	Data on potency
18(B).	Copies of related correspondence with regulatory authorities of country of origin	N/A
19.	Virucidal and bactericidal data	If applicable	If applicable	If applicable
20(A).	Stability data to support expiry date
20(B).	Copies of related correspondence with regulatory authorities of country of origin	N/A
21.	Bluetongue virus testing	If applicable	If applicable	If applicable
22.	Pseudorabies (Aujesky's disease) virus testing	If applicable	If applicable	If applicable
23.	Environmental assessment	If applicable	If applicable	If applicable
24.	Template of Manufacturer's Serial Release Test Report Form to CCVB (3 copies)		N/A
25.	Results on 3 pre-licensing serials
26.	Other supporting documentation (identify)	If applicable	If applicable	If applicable