New Product Submission Checklist - Antibody Products

[Date: yyyy-mm-dd]

No. Name of product: Canadian origin United States (US) origin Other countries origin Check (Checkmark) to confirm inclusion
1. Cover letter introducing submission and identifying regulatory contact Checkmark Checkmark Checkmark  
2. Application for Services - Form CFIA/ACIA 4720 and applicable fees Checkmark Checkmark Checkmark  
3. Veterinary Biologics Information - Form CFIA/ACIA 1503 Checkmark Checkmark Checkmark  
4. Application for Permit To Import Veterinary Biologic into Canada - Form CFIA/ACIA 1493 N/A Checkmark Checkmark  
5. Copy of Veterinary Biological Establishment License, Manufacturing Authorization, or equivalent N/A Checkmark Checkmark  
6. Copy of Veterinary Biological Product License, Marketing Authorization, or equivalent N/A Checkmark Checkmark  
7. Justification for use of veterinary biologic in Canada Checkmark Checkmark Checkmark  
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). (C) Validation data referenced in OP including data for reference standards and product inactivation Checkmark Checkmark Checkmark  
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 Checkmark Checkmark  
10(C). Summary of Product Characteristics N/A N/A Checkmark  
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) Checkmark Checkmark Checkmark  
13. Antigen for hyperimmunization        
13(A). Application for Permit to release of unlicensed vaccine if applicable N/A N/A  
13(A). Master seed(s): purity, safety and identity Checkmark Checkmark Checkmark  
13(C). Genetic characterization data if biotechnology-derived product Checkmark Checkmark Checkmark  
13(D). Master cell stock(s): purity, safety and identify Checkmark Checkmark Checkmark  
14. Efficacy        
14(A). Preliminary data and proof of concept Checkmark N/A Checkmark  
14(B). Protocol(s) Checkmark Checkmark Checkmark  
14(C). Report(s) Pending: tiered review Checkmark Pending: tiered review  
14(D). Copies of related correspondence with regulatory authorities of country of origin N/A Checkmark Checkmark  
15(A). Non interference data, if applicable Checkmark Checkmark Checkmark  
15(B). Copies of related correspondence with regulatory authorities of country of origin N/A Checkmark Checkmark  
16. Safety        
16(A). Laboratory and containment safety studies Checkmark Checkmark Checkmark  
16(B-1). Protocol(s) for field safety studies Checkmark Checkmark Checkmark  
16(B-2). Report(s) for field safety studies Pending: tiered review Checkmark Pending: tiered review  
16(C). Copies of related correspondence with regulatory authorities of country of origin N/A Checkmark Checkmark  
17(A). Data on potency (Antibody content) Checkmark Checkmark Checkmark  
17(B). Copies of related correspondence with regulatory authorities of country of origin N/A Checkmark Checkmark  
18(A). Stability data to support expiry date Checkmark Checkmark Checkmark  
18(B). Copies of related correspondence with regulatory authorities of country of origin N/A Checkmark Checkmark  
19. Environmental assessment If applicable If applicable If applicable  
20. Template of Manufacturer's Serial Release Test Report Form to CCVB (3 copies) Checkmark N/A Checkmark  
21. Results on 3 pre-licensing serials Checkmark Checkmark Checkmark  
22. Other supporting documentation (identify) If applicable If applicable If applicable