4.10E The Regulation of Veterinary Biologics in Canada – Overview

The Canadian Centre for Veterinary Biologics' (CCVB) regulatory program for veterinary biologics (VB) is implemented under the authority of the Health of Animals Act and Regulations. The mandate of the VB regulatory program is to help protect the health of Canadian animals (including domestic livestock, poultry, companion animals, wildlife, and aquatic species) as well as safeguard public health and food safety by controlling indigenous animal diseases and preventing the introduction and dissemination of foreign animal diseases.

Veterinary biologics are a diverse range of products such as vaccines, antibody products, and diagnostic kits which are used for the diagnosis, prevention, control, or treatment of infectious diseases of animals. These VB are derived from microorganisms or materials of animal and/or plant origin, and may be produced by conventional microbiological methods or by modern techniques of biotechnology (for example, plasmid DNA, subunit protein or RNA replicon).

The CCVB is responsible for regulating the manufacturing, testing, labelling, import, export, distribution, and use of VB in Canada. This includes oversight of VB manufacturing facilities, Canadian VB importers, use of experimental unlicensed VB and of autogenous vaccines, and oversight of suspected adverse reactions arising from the use of any VB. The licensing, policy development and inspection activities of the CCVB are supported by CFIA Operations veterinarians responsible for activities such as importer facility inspections, monitoring of field trials and investigating reports of illegal importation.

To license a VB for sale or distribution in Canada, the VB manufacturer must demonstrate the purity, potency, safety and efficacy of the VB when used according to the manufacturer's label claims and indications. To obtain a Veterinary Biologics Establishment Licence and a corresponding CFIA Veterinary Biologics Product License or, in the case of a foreign manufacturer, a CFIA Import Permit for VB, the VB manufacturer must demonstrate that the facilities and manufacturing procedures meet CFIA requirements for manufacturing, testing, labeling, storage, and distribution of VB. These requirements are outlined in the Health of Animals Act and Regulations and related interpretive and technical VB Guidelines and Memoranda.

VB manufacturers are required to implement a quality management program with validated quality controls to ensure the safety and consistency of their VB. The quality controls and processes are subject to regulatory oversight through the CCVB approval of the VB manufacturer's production outline, supporting procedures and labels. VB manufacturers are inspected periodically to verify their conformance with these requirements.

To demonstrate the consistency of the manufacturing process, VB manufacturers are required to submit a summary of the test results for consecutively manufactured pre-licensing serials (batches). In addition, once a VB has been licensed, Canadian and foreign manufacturers require CCVB approval for release of each serial identified for sale or distribution in Canada.

The CCVB is also responsible for review and approval of applications for 'restricted use' of unlicensed VB. This is done in special situations where a licensed VB is not available in Canada, or where studies to support product licensing are to be carried out, or where a VB is required for emergency use. This is done through the issuance of a CFIA Import Permit (for foreign-manufactured VB) or of a Permit to Release Veterinary Biologics (for VB manufactured in Canada). Restrictions and conditions are applied to the proposed use of the VB, depending on the nature of the product, country of origin, target species, intended use (i.e., investigational, research, or emergency purposes), and the associated risks.

VB must be imported directly from a foreign manufacturer's premises, and not from a third party. The importation of any VB into Canada requires a valid import permit issued by the CCVB. There is no exemption from the import permit requirement for small shipments, "personal use" or for emergency or research use.

Post-licensure compliance monitoring is done through the reporting and review of suspected adverse reactions and other consumer complaints. The Health of Animals Regulations require manufacturers to report to the CCVB any information or any evidence of a significant deficiency in safety, potency or efficacy of a VB, within 15 days from the date the information is known.

Canadian licensing requirements for VB and related interpretive and technical VB Guidelines and Memoranda are available on the CFIA-CCVB web site. Further enquiries may be directed to the Canadian Centre for Veterinary Biologics.