Veterinary biologics services: Step 2. Eligibility requirements

What the Canadian Centre for Veterinary Biologics (CCVB) regulates

The CCVB regulates veterinary biologics (VB) under the:

The Health of Animals Act defines a VB as follows:

  • a product that is manufactured, sold or represented for use in restoring, correcting or modifying organic functions in animals or for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state – or its symptoms – in animals and that is:
    • a helminth, protozoa or micro-organism
    • a substance or mixture of substances derived from animals, helminths, protozoa, micro-organisms or plants, or
    • a substance of synthetic origin

What the CCVB does not regulate

The CCVB does not regulate certain products, including:

Refer to the overview of the regulation of veterinary biologics in Canada for more information on what and how the CCVB regulates.

The intended use of the product and its mode of action are also important elements in determining how a product is regulated in Canada. Based on shared characteristics, products for use in animals may also fall into 1 of several regulatory categories. If you're unsure whether your product is considered as a VB you may submit a request to Health Canada's Veterinary Drugs Directorate (VDD) which acts as a single-window for product classifications. For more information, consult Health Canada's classification of products for use in animals.

Find out if you're eligible to apply for VB services

VB manufacturers, importers, and veterinarians are subject to different sets of requirements when applying for services.

The CCVB accepts VB product licensing applications from manufacturers in Canada and other countries with similar animal health status and recognized regulatory systems:

Canadian manufacturers

  • Canadian manufacturers of VB are required to hold:
    • a valid Canadian Veterinary Biologics Establishment Licence
    • a corresponding Canadian Veterinary Biologics Product Licence listing all products produced for sale or distribution

Foreign manufacturers

  • Foreign manufacturers wishing to sell/distribute VB in Canada must designate a Canadian importer to serve as their legally responsible Canadian representative
    • When a VB is licensed in Canada but produced by a foreign manufacturer, it's up to the foreign manufacturer to identify potential Canadian importers
    • The CCVB will issue import permits to suitable designated importers

Importers

  • To apply for Canadian licensing, all imported products must be manufactured and tested in a regulated VB manufacturing facility, in accordance with the foreign country's VB facility licensing requirements and product licensing requirements
    • The foreign country's regulatory approval could be for unrestricted sale within that country, or it could be to authorize manufacturing for export-only sale to importers in other countries
  • If you'd like to be named as a designated importer, please contact the manufacturer of the products in which you're interested in importing
  • Importers of VB in Canada are subject to inspection by Veterinary Biologics Operations inspectors of the Canadian Food Inspection Agency (CFIA)
  • Refer to the requirements for commercial importers of veterinary biologics in Canada (VB-GL-3.33) for more details on the standards that importer-distributors must meet

Veterinarians importing or releasing unlicensed VB for research or emergency use

  • Under certain circumstances, Canadian veterinarians can apply for permission to import a VB that is unlicensed in Canada for use under their supervision for research or emergency situations

Additional information

Refer to veterinary biologics guidelines and forms for resources to help you complete your application, including links to:

  • all necessary forms
  • templates
  • submission checklists
  • relevant guidelines
  • general information
  • external standards
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