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(Check) 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
- Date modified: