On August 8, 2023, the Federal Court overturned Health Canada’s decision that a cannabis product, Edison Jolts, was to be classified as edible cannabis and not cannabis extract. The Court found that Health Canada had breached the duty of procedural
Drug advertising: Updated guidance from Health Canada on the distinction between advertising and other activities for health products
On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in
Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices
Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1, is
New interim order continues expedited authorization pathway for COVID-19 medical devices
The Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3)
Health Canada reports on a national strategy for rare disease drugs
Health Canada has published a report on its public consultation on building a national strategy to address access to drugs for rare diseases. This report follows the Government of Canada’s commitment to create a national strategy for drugs for rare
Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2
Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order
Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework
The Food and Drug Regulations (FDR) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance (NOC) under the FDR.
Two new interim orders update previous orders on medical devices and foreign products during pandemic
The Minister of Health has issued two new interim orders (IOs) regarding authorizations for COVID-19-related products. The first new order extends interim authorizations for COVID-19 medical devices until transition regulations can be passed. The second new order extends
Health Canada consults on proposed guidelines for the use of electronic media in prescription drug labelling
Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers
Health Canada consults on transition of interim order drugs, vaccines, and medical devices to permanent approval pathways
As we have previously reported, the Minister of Health (Minister) approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order for Drugs and Vaccines) on September