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May 24 , 2016

The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) introduces a new power to require certain healthcare institutions to report serious adverse drug reactions and medical device incidents. This requirement is intended to improve the reporting of these types of events and enable the timelier identification and communication of emerging safety issues associated with the use of drugs and medical devices. This power will come into effect when accompanying changes are made to both the Food and Drug Regulations and the Medical Devices Regulations. The regulatory changes will define the applicable healthcare institutions, the data to be provided, and when it must be provided to Health Canada.

 

On May 13, 2016, Health Canada published an Issue Identification Paper on Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Healthcare Institutions.

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The Issue Identification Paper outlines the comments received to date in consultations on how a new reporting requirement could affect the provincial and territorial healthcare environments (HealthCareCAN and the Vanessa’s Law Ottawa Working Group participated in these consultations).

 

Health Canada’s consultations on this initiative continue.  Health Canada is currently seeking feedback of interested parties on the issues identified in the Issue Identification Paper - Mandatory Reporting of Serious Adverse Drug Reactions and Medical Device Incidents by Healthcare Institutions. The consultation is open until July 11, 2016.

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