Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals - Overview

From Health Canada

Overview

This guidance document provides hospitals with information on how to comply with the Food and Drug Regulations and the Medical Devices Regulations with respect to the mandatory reporting of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) to therapeutic products. Serious ADRs and MDIs for marketed therapeutic 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 serious ADR and MDI reports by MHPD for the following marketed therapeutic products:

Important notice
Please note that a discrepancy in the section numbering related to the amended regulations appears in the June 2019 publication of the guidance document. The correct new sections refer to C.01.020.1 of the Food and Drug Regulations and 62 of the Medical Devices Regulations, making it mandatory for hospitals to provide reports to Health Canada about serious adverse drug reactions and medical device incidents. This correction will be included in the next iteration of the guidance document.

Who this guide is for

In this guide

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Details and history

Published: June 26, 2019
Consulted: June 28, 2017

For assistance

Canada Vigilance Program
Health Products Surveillance and Epidemiology Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1908C
Ottawa, Ontario
K1A 0K9

E-mail: hc.canada.vigilance.sc@canada.ca
Telephone: 1-866-234-2345 (toll-free)
Facsimile: 1-866-678-6789

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