New Product Submission Checklist - Export Only

[Date: yyyy-mm-dd]

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