Guide

Veterinary biologic manufactured in Canada: prepare the product-licensing dossier

Check first

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.

Official procedure

Requirements and supporting information

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Official sources consulted August 30, 2026. Orientation guide: confirm current rules, documents, deadlines and conditions with the responsible authority.

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