Veterinary biologics: guidelines and forms

On this page

• Group 1 – Legislation pertaining to veterinary biologics
• Group 2 – Veterinary biologics forms
• Group 3 – Guidelines and information on veterinary biologics
• Group 4 – General information
• Group 5 – Relevant external standards

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 see Part 11, No. 40-50

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 – Canadian Centre for Veterinary Biologics – New or Revised Outline of Production (OP) or Special Outline (SO)
• 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 Prescription Platform Product and Autogenous Veterinary Biologics
• 2.10 – CFIA/ACIA 5936 – Application for permit to release mink coronavirus experimental vaccine for emergency use
• 2.11 – CFIA/ACIA 5977 – Application to authorize a Canadian importer to sell rabies vaccine for use in remote communities where veterinary services are not readily available

Veterinary biologics templates

• Manufacturer's Serial Release Test Report

New product submission checklist

• Vaccines, immunomodulators, and prescription products
• Allergenic extracts, serum, or plasma products
• Autogenous vaccines
• Antibody products
• Diagnostic kits
• Export only
• For further manufacture (FFM)

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
  • 3.21.1 – Guideline for the Release of Unlicensed Veterinary Biologics Manufactured in Canada
  • 3.21.2 – Guideline for the Importation of Unlicensed Veterinary Biologics Manufactured in a Foreign Country
• 3.22 – Requirements for master seed stocks, master cell stocks and veterinary biologic serials
• 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 prions and other infectious agents through veterinary biologics
• 3.33 – Guideline for Commercial Importers of Veterinary Biologics in Canada
• 3.34 – Guideline on Facility Requirements for Veterinary Biologics

Group 4 – General information

• 4.1 – Veterinary Biologics Program Service Standards (Response Times)
• 4.5 – Licensing Requirements for Veterinary Biologics – Overview
• 4.10 – The Regulation of Veterinary Biologics in Canada – Overview
• 4.12 – Importation of Veterinary Biologics – Overview

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)