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.

Learn more about:

• Use of a foreign‐sourced reference product as a Canadian reference product

Contact us

Email: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca.