Consultation for guidance on notifying Health Canada of foreign actions

This was 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We invited stakeholders to provide their comments on the draft guidance document and notification forms.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.

Who was the focus of this consultation

We invited 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)

Contact us

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