Overview of the Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry 

From: Health Canada

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.

Important notice

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

  1. 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

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 Marketed Health Products Directorate to the attention of “Duplicate Reports Notice and/or Reporting AR Guidance Document for Industry Updates”.

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