Post-Notice of Compliance changes: Guidance for safety and efficacy of veterinary drugs: Reporting categories
Contact Health Canada before filing a submission if any of the following conditions apply to the proposed change:
- For Level 1 changes, the data package is comprised solely of publications.
- The clinical study makes use of an end point or statistical method that is new or not validated.
- The clinical study does not reach statistical significance for the primary endpoint or the endpoint used to support the change.
- The clinical study made use of a comparator authorized but not available on the Canadian market.
- For subsequent entry products (generic drugs) where the:
- Canadian reference product is no longer marketed
- clinical study or publication makes use of a non‐Canadian reference product as a comparator
- sponsor seeks approval of a strength outside of the Canadian reference product dosing range
Sponsors should also contact us before filing a submission if:
- you wish to discuss product specific data requirements
- the existing guidance or policies are unclear or do not cover specific situations
Depending on the issue or concern, we may arrange a pre‐submission meeting to allow for more in-depth discussion.
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