Notice to industry: Clarification of section 4.3 of the Reporting adverse reactions to Marketed Health Products – Guidance Document for Industry
Published: February 19, 2026
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Intended audience
Market Authorization Holders (MAHs) for drugs (pharmaceuticals, biologics, and radiopharmaceuticals) and natural health product (NHPs).
Objective
The intent of this notice is to clarify Health Canada's expectations regarding the reporting of cases identified from the Canada Vigilance (CV) Adverse Reaction (AR) Online Database by MAHs. In particular, this notice replaces section 4.3 of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry (2018) and the Notice to Industry (2020).
This initiative supports the Government of Canada’s commitment to reduce red tape by simplifying regulations, streamlining processes and addressing unnecessary requirements that burden industry.
Issue
The current guidance has given rise to a significant increase in duplicate reporting and industry burden. The revised guidance in this notice is intended to reduce these issues.
We refer to Health Canada as "us", and to MAHs as "you" or "your".
Revised guidance
4.3 Regulatory Authority Sources
Reports from the CV Online Database and the Health Product InfoWatch
For Individual Case Safety Report (ICSR) reporting obligations (section C.01.017 of the Food and Drug Regulations, and section 24 of the Natural Health Products Regulations), MAHs are not required to scan the CV Online Database or the Health Product InfoWatch.
Reports from foreign regulatory authority databases
You must report to Health Canada individual serious unexpected adverse reaction reports, which occurred outside of Canada; for example, those originating from foreign regulatory authorities.
You are not required to submit ICSRs from these foreign databases if you can determine that the product is not yours, based on the following “Exclusion Criteria for Product Identification”:
- country of marketing,
- product name,
- active ingredient name,
- pharmaceutical form,
- batch number,
- marketing status, or
- other characteristics.
If unable to determine if the product is yours, then you should presume that it is, report the ICSR to us, and indicate that you couldn't identify the specific brand.
Note: You may also apply these “Exclusion Criteria for Product Identification” to foreign adverse reaction reports coming from any sources; for example, scientific literature reports.
Additionally, these exclusion criteria override the criteria mentioned in sections “2.1.2 Foreign Adverse Reaction Reports” and “4.1.3 Scientific Literature Reports” of the current Health Canada guidance document, Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry (2018).
Implementation
This modified guidance is effective as of the date of posting of this notice.
Contact us
If you have any questions, please contact the Canada Vigilance Program by email: canadavigilance@hc-sc.gc.ca.