Consultation for guidance on notifying Health Canada of foreign actions

Health Canada is holding a 60-day consultation on revisions to:

• Notifying Health Canada of Foreign Actions - Guidance Document for Industry, now entitled
  "Guidance on notifying Health Canada of foreign actions"
• Notification of foreign actions reporting forms

We invite stakeholders to provide their comments on the draft guidance document and notification forms. We will consider all input and feedback received before publishing the final versions.

The update aims to address gaps and clarify issues identified in the existing guidance document. The update will also incorporate efficiencies associated with follow-up actions related to reporting, along with plain-language edits. The expected benefits of these updates include improved clarity and efficiencies for both the industry and Health Canada.

How to participate

Interested stakeholders should read and review the new draft guidance document and notification forms:

• Draft guidance on notifying Health Canada of foreign actions
• Draft form: Notifying Health Canada of foreign actions in respect of a serious risk of injury to human health (GMP or manufacturing site, product quality, product recall)
• Draft form: Notifying Health Canada of foreign actions in respect of a serious risk of injury to human health (safety signals or toxicity, adverse reactions, unsafe use)

Send your comments in an email to mhpdpolicy-politiquesdpsc@hc-sc.gc.ca. In the subject line, include "Notifying Health Canada of Foreign Actions – Consultation Comments"

The deadline for feedback is November 24, 2025.

Who is the focus of this consultation

We invite all interested Canadians and stakeholders to provide their comments, in particular:

• Market Authorization Holders (MAHs) of
  • Prescription drugs
  • Drugs that are required to be sold under a prescription by Part G of the Food and Drug Regulations, the Benzodiazepines and Other Targeted Substances Regulations or the Narcotic Control Regulations
  • Drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner
• Other industry stakeholders

Related links and information

• Existing guideline: Notifying Health Canada of Foreign Actions - Guidance Document for Industry - Canada.ca
• Current reporting forms:
  • Notifying Health Canada of foreign actions in respect of a serious risk of injury to human health (for foreign actions involving safety or toxicity, adverse reactions or unsafe use)
  • Notifying Health Canada of Foreign Actions in respect of a Serious Risk of Injury to Human Health - Canada.ca (for foreign actions involving GMP or the manufacturing site, a product quality issue, or a product recall)

Note: We are currently in the process of developing and updating other post-market vigilance guidance documents. Once published, these documents will provide additional guidance relevant to the notification of foreign actions. The relevant guidance documents include:

• Guidance on preparing and submitting summary reports for marketed drugs and natural health products
• Management of post-market vigilance submissions guidance
• Good pharmacovigilance practices (GVP) guidelines (GUI-0102)

Stakeholders will have the opportunity to review these guidance documents and provide comments. We will consider comments relating the relationship between the notification of foreign actions and these other guidance documents, where applicable.

Contact us

MHPD Policy-Regulatory Policy Section
Marketed Health Products Directorate
Health Canada
Email: mhpdpolicy-politiquesdpsc@hc-sc.gc.ca