Veterinary biologics: guidelines and forms
On this page
- Legislation pertaining to veterinary biologics
- Forms
- Templates
- Product submission checklists
- Guidelines
- General information
- Relevant external standards
Legislation pertaining to veterinary biologics
- Health of Animals Act
- Health of Animals Regulations
- Canadian Food Inspection Agency Fees Notice see Part 11, Number 40 to 50
Forms
- CFIA/ACIA 4720 – Application for Services
- CFIA/ACIA 1493 – Application for Permit to Import Veterinary Biologics into Canada
- CFIA/ACIA 1503 – Veterinary Biologic Information
- CFIA/ACIA 2205 – Notification of Suspected Adverse Events to Veterinary Biologics
- CFIA/ACIA 5761 – Canadian Centre for Veterinary Biologics (CCVB) – Product Label Submission
- CFIA/ACIA 5212 – Canadian Centre for Veterinary Biologics – New or Revised Outline of Production (OP) or Special Outline (SO)
- 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
- CFIA/ACIA 5214 – Application for Renewal of Veterinary Biologics Establishment Licence and Product Licence
- CFIA/ACIA 5569 – Information Required for Prescription Platform Product and Autogenous Veterinary Biologics
- 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
- CFIA/ACIA 5986 – Veterinarian's application for an import permit for an unlicensed veterinary biologic for research or emergency use
Templates
Product submission checklists
- Vaccines, immunomodulators, and prescription products
- Allergenic extracts, serum, or plasma products
- Autogenous vaccines
- Antibody products
- Diagnostic kits
- Export only
- For further manufacture (FFM)
Guidelines
- VB-GL-3.1: Preparation of new product licensing (registration) submissions for veterinary biologics
- VB-GL-3.1.1: Preparation of new product licensing (registration) submissions for veterinary biologics manufactured in Canada
- VB-GL-3.1.2: Preparation of new product licensing (registration) submissions for veterinary biologics manufactured and/or licensed in the United States
- VB-GL-3.1.3: Preparation of new product licensing (registration) submissions for veterinary biologics manufactured in foreign countries other than the United States
- VB-GL-3.2: Regulation of biotechnology-derived veterinary biologics
- VB-GL-3.3: Labelling of veterinary biologics
- VB-GL-3.4: Pre-submission consultation meetings and advance notification of new product licensing submissions
- VB-GL-3.5: Advertising of veterinary biologics
- VB-GL-3.6: Bluetongue virus exclusion testing of veterinary biologics
- VB-GL-3.7: Preparation of outlines of production, special outlines, and summary of changes for veterinary biologics
- VB-GL-3.11: Inspection of veterinary biologics manufacturers and importers
- VB-GL-3.13: Autogenous veterinary biologics
- VB-GL-3.15: Reporting suspected adverse events related to veterinary biologics
- VB-GL-3.16: Registration of immunoglobulin supplements
- VB-GL-3.17: Reporting laboratory and field efficacy trials
- VB-GL-3.19: Licensing veterinary diagnostic test kits in Canada
- VB-GL-3.21: Importation and/or release of unlicensed veterinary biologics for research or emergency use
- VB-GL-3.22: Master seed stocks, master cell stocks and serial requirements
- VB-GL-3.23: Licensing veterinary nucleic acid vaccines
- VB-GL-3.24: Inspection of veterinary biologics importers
- VB-GL-3.26: Issuance of veterinary biologics export certificates
- VB-GL-3.28: Requirements for the personnel involved in the manufacturing, testing, and importation of veterinary biologics
- VB-GL-3.29: Safety requirements for veterinary biologics
- VB-GL-3.31: Pseudorabies virus exclusion testing of veterinary biologics
- VB-GL-3.32: Minimising the risk of introducing transmissible spongiform encephalopathy prions and other infectious agents through veterinary biologics
- VB-GL-3.33: Canadian commercial importers of veterinary biologics
- VB-GL-3.34: Requirements for veterinary biologics facilities
General information
- Veterinary Biologics Program service standards (response times)
- Licensing requirements for veterinary biologics – Overview
- The regulation of veterinary biologics in Canada – Overview
- Importation of veterinary biologics – Overview
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)
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