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
Group 2 – Veterinary Biologics Forms
- 2.1 – CFIA/ACIA 4720 – Application for Services
- 2.2 – CFIA/ACIA 1493 – Application for Permit to Import Veterinary Biologics into Canada
- 2.3 – CFIA/ACIA 1503 – Veterinary Biologic Information
- 2.4 – CFIA/ACIA 2205 – Notification of Suspected Adverse Events to Veterinary Biologics
- 2.5 – CFIA/ACIA 5761 – Canadian Centre for Veterinary Biologics (CCVB) – Product Label Submission
- 2.6 – CFIA/ACIA 5212 – Revisions to Outlines of Production and Special Outlines for Veterinary Biologics (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
- 2.8 – CFIA/ACIA 5214 – Application for Renewal of Veterinary Biologics Establishment Licence and Product Licence
- 2.9 – CFIA/ACIA 5569 – Information Required for Autogenous Veterinary Biologics
Veterinary Biologics Templates
New Product Submission Checklist
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 – General Information
- 4.5 – Licensing Requirements for Veterinary Biologics in Canada
- 4.10 – The Regulation of Veterinary Biologics in Canada
- 4.11 – Reporting Suspected Adverse Events Related to Veterinary Biologics
- 4.12 – Importation of Veterinary Biologics - Overview
- 4.13 – Veterinary Biologics Program Service Standards (Response Times)
Group 5 – Relevant External Standards
- The Canadian Biosafety Standards and Guidelines
- Canadian Council on Animal Care (CCAC) Guidelines
- Codes of Practice for Care of Farm Animals
- Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)
- Date modified: