Overview of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry
Update: Please note that a new notice to industry has been published February 19, 2026, providing additional details related to sections “2.1.2 Foreign Adverse Reaction Reports”, “4.1.3 Scientific Literature Reports” and "4.3 Regulatory Authority Sources" of this guidance document.
For more information, see Notice to industry: Clarification of section 4.3 of the Reporting adverse reactions to Marketed Health Products – Guidance Document for Industry.
Overview
This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products, but excluding blood and blood components and cells, tissues and organs. ARs for marketed health products within the scope of this guidance document are to be reported to the Canada Vigilance Program of the Marketed Health Products Directorate (MHPD) of Health Canada. This guidance document covers the collection of individual AR reports by MHPD for the following marketed health products:
- pharmaceutical drugs (which includes prescription and non-prescription pharmaceutical drugs);
- biologics as set out in Schedule D to the Food and Drugs Act (which include biotechnology products, vaccines and fractionated blood products);
- radiopharmaceutical drugs set out in Schedule C to the Food and Drugs Act; and
- natural health products as defined in Section 1 of the Natural Health Products Regulations.
Who this guide is for
- The guide is intended for regulated parties (industry) who are affected by the regulation as it pertains to the reporting of adverse reactions to marketed health products.
In this guide
Related guides and help
Related acts and regulations
Related program
- 1 Introduction
- 2 General Procedures for Expedited Adverse Reaction Reporting
- 3 Good Case Management Practices
- 3.1 Minimum Criteria for an Adverse Reaction Report
- 3.2 Assessing Patient and Reporter Identifiability
- 3.3 The Role of Narratives
- 3.4 Follow-up Information
- 3.5 Evaluation and Coding of Adverse Reaction Reports
- 3.6 Contractual Agreements
- 3.7 Records to be Held for Auditing (C.01.020)
- 3.8 Key Data Elements
- 4 Adverse Reaction Reports by Source
- Appendix 1 Glossary: Definitions and Terminology
- Appendix 2 References
- Appendix 3 Abbreviations
- Appendix 4 Contact Information
- Appendix 5 Other Adverse Reaction Reporting Programs Outside the Scope of this Document
- Appendix 6 World Health Organization Causality Algorithm
- Appendix 7 Summary of Expedited Post-Market AR Reporting Requirements to MHPD
View complete guide
Download PDF (394 KB, 21 pages)
Details and history
Published: May 23, 2018
Part of topic(s): Guidance on legislation
For assistance
Contact the Canada Vigilance Program.