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Regulatory cooperation - Canadian Guidance on Veterinary Drug Simultaneous Reviews with the United States: Cancellation process, contact us

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Cancelling

Sponsors who wish to continue to seek marketing authorization in Canada but not continue with the simultaneous review process must file a new drug submission (NDS) or supplement to a new drug submission (SNDS) to Health Canada's Veterinary Drug Directorate (VDD).

For more information, please consult the following guidance:

The standard VDD review process and targets will apply to the newly submitted submission.

Contact us

For questions on the Canadian RCC regulatory process, contact:

Veterinary Drugs Directorate
Health Products and Food Branch
Health Canada

To express interest in the Regulatory Cooperation Council (RCC) pathway before filing a submission, email:

For questions on the Experimental Study Certificate, protocol review, pre-submission meeting and general submission-related inquiries, email:

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2022-12-16

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