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New Product Submission Checklist - Export Only

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[Date: yyyy-mm-dd]

No. Name of product: Canadian origin Check (Check) to confirm inclusion
1. Cover letter introducing submission and identifying regulatory contact R
2. Application for Services - Form CFIA/ACIA 4720 and applicable fees R
3. Veterinary Biologics Information - Form CFIA/ACIA 1503 R
4. Official document from the regulatory authorities of the importing country indicating acceptance of the product R
5. Outline of Production (OP) 2 copies
6(A). Related Outlines of Production 2 copies of each
6(B). Referenced Special Outlines (SO) and SOPs (if not already on file at CCVB) 2 of each if new
6(C). Validation data referenced in OP including data for reference standards and product inactivation R
7(A). Draft or final labels for each importing country 2 copies of each, including insert
7(B). Certified translation in English or French of the labels in foreign language(s) used in the importing country(ies) R
8(A). Material of Animal Origin (MAO) - SO 2 copies
8(B). MAO - Supplier documents 1 copy
9. Declaration of Compliance regarding TSE (original) R
10(A). Vaccines - Master seed(s): purity, safety and identity R
10(B). Genetic characterization data if biotechnology-derived product (vaccines) R
11. Vaccines - Master cell stock(s): purity, safety and identity R
12. Vaccines - Proof of efficacy/ immunogenicity data R
13. Vaccines - Laboratory safety data R
14. Diagnostic kits - Data on laboratory performance R
15. Other supporting documentation (identify) If applicable

R: Required

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