Tag archives: COVID-19

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 No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO … Continue reading

Federal Court of Appeal Restores Suspension Period

On April 21, 2021, the Federal Court of Appeal (FCA) announced that it will restore the Suspension Period by default for all new matters and begin reinstating the Suspension Period on existing matters by removing them from its Selected Files List. Selected Files As previously reported in June 2020 (June 2020 Update), the FCA began … Continue reading

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 16, 2020 and the Interim order respecting the importation and sale of medical devices for use in relation to … Continue reading

New Interim Order to expedite the approval of COVID-19 drugs and vaccines

On September 16, 2020, the Minister of Health signed an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order) which provides new regulatory pathways to expedite the approval of COVID-19 drugs and vaccines that have not yet been approved for sale in Canada. It also … Continue reading

Federal Courts update guidance on COVID-19

The Federal Court of Appeal (FCA) provided updated guidance for resuming hearings starting September 1, 2020 and clarified the effect of the federal Time Limits and Other Periods Act (COVID-19) on timelines for commencing and conducting litigation in the FCA. Both the FCA and the Federal Court confirmed that all Practice Directions, judgments, orders and … Continue reading

Federal Courts Extend Suspension Periods to June 15

The Federal Court of Appeal (FCA) and the Federal Court (FC) have extended their Suspension Periods to June 15, 2020. Federal Court of Appeal On May 28, 2020, the FCA issued a Notice to the Parties and the Profession extending the Suspension Period to June 15, 2020. Federal Court On May 29, 2020, the FC issued … Continue reading

Update: Expanded Federal Funding for Research and Innovation

As we reported in March, the Federal Government pledged $275 million to research relating to COVID-19. On April 23, 2020, an additional $1.1 billion in funding was announced and includes funding for: Research and Data: $114.9 million for research to accelerate the development, testing, and implementation of medical and social countermeasures to COVID-19. This will … Continue reading

Health Canada issues Interim Order to address shortages of health products

Health Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. It was signed by the Minister … Continue reading

Ontario and Quebec Introduce Changes to Pharmacy Practice and Highlight the Drug Supply Chain as an Essential Service

Changes Affecting Ontario The Government of Ontario has made changes to the Ontario Drug Benefit (ODB) Program in an effort to reduce the risk of drug shortages in the province during the COVID-19 outbreak. Effective immediately, ODB eligible drugs are subject to the following changes to rules on dispensing and fees: The dispensing of medication … Continue reading

COVID-19: Sharing information for licensed health products during a pandemic

The public health call for social distancing to help curb the COVID-19 pandemic has no doubt already affected how companies will be sharing information about pharmaceuticals and other licensed health products with healthcare professionals (HCPs), patients, and the public. As industry plays its part in keeping sales representatives and medical science liaisons (MSLs) home to … Continue reading

COVID-19: Health Canada Issues Bulletin Confirming Obligations of DEL Holders

In light of recent developments relating to the to the 2019 novel coronavirus (COVID-19), Health Canada recently sent a reminder to all Drug Establishment License (DEL) holders of their obligations under the Food and Drug Regulations (FDR) regarding reporting of events that could affect operations and lead to shortages or issues affecting quality, safety, and … Continue reading
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