Service Standard for the Review of 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)

Review initial submission and prepare response.

Performance Target

The target to review initial submissions and prepare a response is four months.

Performance Results

Annual performance:

  • 2016-17: the Agency reviewed and prepared a response for 79% of the initial submissions within the service standard. Footnote 1
  • 2015-16: the Agency reviewed and prepared a response for 50% of the initial submissions within the service standard.
  • 2014-15: the Agency reviewed and prepared a response for 68% of the initial submissions within the service standard.
  • 2013-14: the Agency reviewed and prepared a response for 87% of the initial submissions within the service standard.

Applying for a New Licensing SubmissionFootnote 2 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:

Service feedback

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

For more information

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

Date modified: