Overview of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry
Health Canada is clarifying expectations for manufacturers, importers and market authorization holders on the requirement to report adverse reactions and medical device problems during the pandemic.
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.
In the event a report contains no new information relative to the causality assessment of a health product’s safety and effectiveness, MAH reports originating from the CV Online Database are not required to be re-submitted to the CVP by the MAH. Health Canada expects this information will continue to be captured in annual summary reports (ASRs).
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
- 1 Introduction
- 2 General Procedures for Expedited Adverse Reaction Reporting
- 2.1 Domestic and Foreign Adverse Reaction Reports
- 2.2 Other Adverse Reaction Report Types
- 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
- 4.1 Unsolicited Reports
- 4.2 Solicited Reports
- 4.3 Regulatory Authority Sources
- 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
Details and history
Published: May 23, 2018
Part of topic(s): Guidance on legislation
Contact the Canada Vigilance Program.
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