We would like to ensure that you are still receiving content that you find useful – please confirm that you would like to continue to receive ILO newsletters.
08 August 2018
On 15 June 2018 Health Canada announced the publication of proposed Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals) and Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals). The regulations specify that for the purposes of Section 21.8 of the Food and Drugs Act, as amended by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), hospitals are the prescribed healthcare institutions that must provide information in their control to the minister of health.
Pursuant to the proposed amendments, all hospitals must provide the specified information relating to serious adverse drug reactions and medical device incidents (as defined in the proposed amendments) directly to Health Canada within 30 days of first documenting the reaction or incident in the hospital. The reporting requirements apply to:
However, the requirements exclude these products when used in clinical trials or as part of the Special Access Programme. The consultation period will end on 30 August 2018.
For further information on this topic please contact Urszula Wojtyra at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
The materials contained on this website are for general information purposes only and are subject to the disclaimer.
ILO is a premium online legal update service for major companies and law firms worldwide. In-house corporate counsel and other users of legal services, as well as law firm partners, qualify for a free subscription.