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
On December 16, 2019, amendments to the Food and Drug Regulations and Medical Devices Regulations will come into force making it mandatory for hospitals to provide reports to Health Canada about serious adverse drug reactions and medical device incidents.

Who this guide is for

In this guide

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Download PDF (657 KB, 46 pages)

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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