New Product Submission Checklist - Diagnostic Kits

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[Date: yyyy-mm-dd]

No. Name of product: Origin
Canada
(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 antigen 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. Antigen in the kit
13(A). Master seed(s): purity and identity R R R
13(B). Genetic characterization data if biotechnology-derived product R R R
14. Master cell stock(s): purity and identity
14(A). Cell lines(s) for viral antigen(s) R R R
14(B). Hybridomas for monoclonal antibodies R R R
15. Efficacy/ Performance
15(A). (A) Preliminary data and proof of concept R N/A R
15(B-1). Protocol(s) on reproducibility (Potency) R R R
15(B-2). Report(s) - Data on reproducibility Pending: phased review R Pending: phased review
15)C-1). Protocol(s) on repeatability R R R
15(C-2). Report(s) - Data on repeatability Pending: phased review R Pending: phased review
15(D-1). Protocol(s) on field performance R R R
15(D-2). Report(s) of field performance from different laboratories Pending: phased review R Pending: phased review
15(D-3). Summary report of field performance from the manufacturer Pending: phased review R Pending: phased review
15(E). Estimates of specificity and sensitivity R R R
15(F). Copies of related correspondence with regulatory authorities of country of origin N/A R R
16(A). Non cross-reactivity data R R R
16(B). Copies of related correspondence with regulatory authorities of country of origin N/A R R
17. Guidance on laboratory bio-safety, handling and disposal R R R
18(A). Stability data to support expiry date R R R
18(B). Copies of related correspondence with regulatory authorities of country of origin N/A R R
19. Environmental assessment If applicable If applicable If applicable
20. Template of Manufacturer's Serial Release Test Report Form to CCVB (3 copies) R N/A R
21 Results on 3 pre-licensing serials R R R
22. 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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