Guidance for industry on notifying Health Canada of foreign actions: Notice
On this page
- New guidance for notifying Health Canada of foreign actions
- Consultations
- Transitioning to the new guidance
- Contact us
New guidance for notifying Health Canada of foreign actions
The current Notifying Health Canada of Foreign Actions guidance was published on November 20, 2018.
A revised guidance will come into effect on October 1, 2026.
The revised guidance clarifies the requirements to notify Health Canada of foreign actions, updates notification forms, and addresses issues that have led to duplicate or unnecessary reporting. Consistent with Health Canada’s red tape reduction efforts, it also decreases the reporting burden on market authorization holders by reducing the number of foreign regulatory authorities to which these regulatory requirements apply, by more than half.
These changes reinforce Health Canada’s support for a life cycle approach to drug regulation within the existing regulatory framework.
- Revised guidance on notifying Health Canada of foreign actions
- List of regulatory authorities for the purpose of notifying Health Canada of foreign actions
Consultations
The proposed revisions were published in September 2025 for a 60-day consultation period.
We received a total of 184 comments from industry stakeholders and individuals. The key themes of these comments were:
- Challenges of reporting within the prescribed period
- Requests to update and reduce the list of foreign authorities
- Requests to clarify when obligations arise from foreign actions related to label changes
- Interpretation of triggers and thresholds for notification
We considered all comments when updating the guidance document and related internal processes.
Transitioning to the new guidance
Changes have been made to the previous guidance to clarify policy, streamline the reporting process, and improve the reporting tool. The revised guidance will take effect on October 1, 2026 to allow sufficient time for industry to implement the necessary changes.
While no further formal consultations on this guidance are planned, we welcome feedback for consideration in future updates to the guidance and regulations. You may submit your feedback by email to mhpdpolicy-politiquesdpsc@hc-sc.gc.ca.
Contact us
Integrated Policy and Stakeholder Engagement Section
Marketed Health Products Directorate
Health Canada
Email: mhpdpolicy-politiquesdpsc@hc-sc.gc.ca