Guidelines and Forms

Group 1, Group 2, Group 3, Group 4

Group 1 – Legislation pertaining to Veterinary Biologics

• 1.1 – Health of Animals Act
• 1.2 – Health of Animals Regulations
• 1.3 – Canadian Food Inspection Agency Fees Notice – Part 11, Health of Animals Fees
• 1.4 – Veterinary Biologics Program Service Standards (Response Times)

Group 2 – Veterinary Biologics Forms

• 2.1 – CFIA/ACIA 4720 – Application for Services – PDF (311 kb)
• 2.2 – CFIA/ACIA 1493 – Application for Permit to Import Veterinary Biologics into Canada – PDF (163 kb)
• 2.3 – CFIA/ACIA 1503 – Veterinary Biologics Information Form – PDF (93 kb)
• 2.4 – CFIA/ACIA 2205 – Notification of Suspected Adverse Events to Veterinary Biologics – PDF (254 kb)
• 2.5 – CFIA/ACIA 5189 – Summary of Fees and Services Related to Veterinary Biologics – PDF (98 kb)
• 2.6 – CFIA/ACIA 5212 – Revisions to Outlines of Production and Special Outlines for Veterinary Biologics – PDF (165 kb) (Licensed in the United States)
• 2.7 – CFIA/ACIA 5213 – Application for the Renewal of Product Licensing and Renewal of Import Permits for Licensed Veterinary Biologics Manufactured in the USA or in Other Foreign Countries – PDF (139 kb)
• 2.8 – CFIA/ACIA 5214 – Application for Renewal of Veterinary Biologics Establishment Licence and Product Licence – PDF (134 kb)
• 2.9 – CFIA/ACIA 5569 – Information Required for Autogenous Veterinary Biologics – PDF (97 kb)

Veterinary Biologics Templates

• Manufacturer's Serial Release Test Report

New Product Submission Checklist

• Vaccines
• Autogenous Vaccines
• Antibody Products
• Diagnostic Kits
• Export Only

Group 3 – Guidelines and Information on Veterinary Biologics

• 3.1 – Guidance for Preparation of New Product Licensing (Registration) Submissions for Veterinary Biologics
• 3.2 – Guideline for Regulation of Biotechnology-Derived Veterinary Biologics
• 3.3 – Guideline for Labelling of Veterinary Biologics
• 3.4 – Guideline for Pre-Submission Consultation Meetings and Advance Notification of New Product Licensing Submissions
• 3.5 – Guideline for Advertising of Veterinary Biologics
• 3.6 – Guideline for Bluetongue Virus Exclusion Testing of Veterinary Biologics
• 3.7 – Guideline for Preparation of Production Outlines, Special Outlines, and Summary of Changes for Veterinary Biologics
• 3.11 – Guideline for Inspection of Veterinary Biologics Manufacturers and Importers
• 3.13 – Guideline for Autogenous Veterinary Biologics
• 3.15 – Guideline for Reporting Suspected Adverse Events Related to Veterinary Biologics
• 3.16 – Guideline for Registration of Immunoglobulin Supplements
• 3.17 – Guideline for Reporting Laboratory and Field Efficacy Trials
• 3.19 – Guideline for Licensing Veterinary Diagnostic Test Kits in Canada
• 3.21 – Guideline for the Importation and/or Release of Unlicensed Veterinary Biologics for Research or Emergency Use
• 3.22 – Guideline for Submission, Testing and Reporting of Veterinary Biological Samples
• 3.23 – Guideline for Licensing Veterinary Nucleic Acid Vaccines
• 3.24 – Guideline for Inspection of Veterinary Biologics Importers
• 3.26 – Guideline for Issuance of Veterinary Biologics Export Certificates
• 3.28 – Guideline for Personnel Requirements
• 3.29 – Guideline for Safety Requirements for Veterinary Biologics
• 3.31 – Guideline for Pseudorabies Virus Exclusion Testing of Veterinary Biologics
• 3.32 – Guideline for Minimising the Risk of Introducing Transmissible Spongiform Encephalopathy Agents through Veterinary Biologics
• 3.33 – Guideline for Commercial Importers of Veterinary Biologics in Canada

Group 4 – References

• 4.1 – Public Health Agency of Canada Laboratory Biosafety Guideline
• 4.3 – Canadian Council on Animal Care (CCAC) Guidelines
• 4.4 – Codes of Practice for Care of Farm Animals
• 4.5 – Licensing Requirements for Veterinary Biologics in Canada
• 4.7 – Containment Standards for Veterinary Facilities
• 4.10 – The Regulation of Veterinary Biologics in Canada

Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)

Although the CCVB intends to adopt VICH guidelines as primary guidance documents, they are to be viewed as administrative instruments and not specified requirements of the Health of Animals Act and Regulations and therefore allow for flexibility of approach.

• Guidelines