Open ProvincesVeterinary biologic manufactured in Canada: prepare the product-licensing dossier
Veterinary biologic manufactured in Canada: prepare the product-licensing dossier
Product licensing, establishment licensing and any import permit are separate authorizations.
Confirm the right process
Confirm that the product is a veterinary biologic and use the guidance for Canadian manufacturers.
Prepare the dossier
Compile purity, potency, safety and efficacy evidence with the required manufacturing and labelling information.
Submit the application
Coordinate the dossier with the Canadian Centre for Veterinary Biologics, including inspections and applicable prior approvals.
Follow up
Distribute only under issued authorizations; arrange serial release, renewal, amendments and adverse-event reporting.
Requirements and supporting information
Sources and limits
Official sources consulted August 30, 2026. Orientation guide: confirm current rules, documents, deadlines and conditions with the responsible authority.
General information based on federal and national rules; provincial rules may differ. Confirm with the official body before acting. Last reviewed : 2026-08-30.