New Product Submission Checklist - Vaccines

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[Date: yyyy-mm-dd]

No. Name of product: Origin
Canadian (CAN) United States (US) Other countries Check (checkmark) to confirm inclusion
1. Cover letter introducing submission and identifying regulatory contact R R R
2. Application for Services - Form CFIA/ACIA 4720 and applicable fees R R R
3. Veterinary Biologics Information - Form CFIA/ACIA 1503 R R R
4. Application for Permit To Import Veterinary Biologics into Canada - Form CFIA/ACIA 1493 N/A R R
5. Copy of United States Veterinary Biologics Establishment License, Manufacturing Authorization, or equivalent N/A R R
6. Copy of United States Veterinary Biological Product License, Marketing Authorization, or equivalent N/A R R
7. Justification for use of veterinary biologic in Canada R R R
8. Outline of Production (OP) 2 copies 1 copy + APHIS 2015 and S of C 2 copies
9(A). Related Outlines of Production 2 copies of each 1 of each 2 copies of each
9(B). Referenced Special Outlines (SO) and SOPs (if not already on file at CCVB) 2 of each if new 1 of each
if new
2 of each if new
9(C). Validation data referenced in OP including data for reference standards and product inactivation R R R
10(A). Draft or final labels 2 copies of each, including insert 2 copies of each, including insert 2 copies of each, including insert
10(B). Photocopies of approved labels in the country-of-manufacture for reference only N/A R R
10(C). Summary of Product Characteristics N/A N/A R
11(A). Material of Animal Origin (MAO) - SO 2 copies 1 copy (US)
2 copies (CAN)
2 copies
11(B). MAO - Supplier documents 1 copy 1 copy 1 copy
12. Declaration of Compliance regarding TSE (original) R R R
13(A). Master seed(s): purity, safety and identity R R R
13(B). Genetic characterization data if biotechnology derived product R R R
14. Master cell stock(s): purity, safety and identity R R R
15. Efficacy/ Immunogenicity
15(A). Preliminary data and proof of concept R N/A R
15(B). Protocol(s) R R R
15(C). Report(s) Pending: phased review R Pending: phased review
15(D). Copies of related correspondence with regulatory authorities of country of origin N/A R R
16(A). Non interference data, if applicable R R R
16(B). Copies of related correspondence with regulatory authorities of country of origin N/A R R
17. Safety
17(A). Data on genetic stability/non-reversion to virulence (live or biotechnology products) R R R
17(B). Laboratory and containment safety studies R R R
17(C). Protocol(s) for field safety studies R R R
17(D). Report(s) for field safety studies Pending: phased review R Pending: phased review
17(E). Non target species (if applicable) R R R
17(F). Human safety (including food safety) R R R
17(G). Adjuvant safety, if novel R R R
17(H). Copies of related correspondence with regulatory authorities of country of origin R R R
18(A). Data on potency R R R
18(B). Copies of related correspondence with regulatory authorities of country of origin N/A R R
19. Virucidal and bactericidal data If applicable If applicable If applicable
20(A). Stability data to support expiry date R R R
20(B). Copies of related correspondence with regulatory authorities of country of origin N/A R R
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) R N/A R
25. Results on 3 pre-licensing serials R R R
26. Other supporting documentation (identify) If applicable If applicable If applicable

Legend
N/A: Not Applicable
R: Required
S of C: Summary of Changes

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