Service Standard for the Review of a New Product Licensing Submission for Veterinary Biologics

Review initial submission and prepare response.

The Canadian Centre for Veterinary Biologics completes the initial review of new licensing submission and prepares a response within 150 days (regardless of the country of origin). New veterinary biologics licensing submissions with major omissions will not be reviewed.

Performance Target

The target for achieving this standard is set at 90%

Performance Results

Annual performance:

• 2018-19: the Agency reviewed and prepared a response for 100% of the initial submissions within the service standard.

Applying for a New Licensing Submission Change in Formulation or Change in Label Claims for a Veterinary Biologic Manufactured in the United States (Review with Emphasis on Canadian Requirements)

Licensing submissions must conform with the:

• Veterinary Biologics Guideline 3.1-2 - Guidance for Preparation of New Product Licensing (Registration) Submissions for Veterinary Biologics Manufactured and/or Licensed in the United States
• Veterinary Biologics Guideline 3.3 - Guideline for Labelling of Veterinary Biologics
• Veterinary Biologics Guideline 3.7 – Guideline for Preparation of Production Outlines, Special Outlines, and Summary of Changes for Veterinary Biologics

Service feedback

If you have a service complaint, please complete a Feedback Form or communicate with one of our Contacts.

For more information

• Federal regulatory management and modernization
• Government-Wide Forward Regulatory Plans
• The Canada-United States Regulatory Cooperation Council

To learn about upcoming or ongoing consultations on proposed federal regulations, visit the Canada Gazette and Consulting with Canadians websites.