This guidance document on submitting risk management plans, published on February 24, 2025, will come into effect on July 1, 2025.
In the meantime the Guidance Document – Submission of Risk Management Plan and Follow-up Commitments published in June 2015 will remain in effect, along with the supporting notices:
- Notice of clarification to drug manufacturers and sponsors – Risk Management Plans – Update (August 13, 2020)
- Notice of clarification to drug manufacturers and sponsors: Canadian-specific considerations in risk management plans (November 12,2020)
For more information on risk management plans guidance, and transitioning to the new regulations, consult:
