Tag archives: Health Canada

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

Health Canada Provides Guidance on Regulation of Software as a Medical Device (SaMD)

On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) as well as information on classification of SaMD. What … Continue reading

Top Headlines of 2018

Last year ushered in a number of changes to the Canadian pharmaceutical and life sciences sector. 2018 also served as a year to explore the impacts of major intellectual property decisions and regulatory changes from 2017 including the impact of the Supreme Court’s decision in NEXIUM striking down the Promise Doctrine and the implementation of … Continue reading

Health Canada proposes regulations allowing importation of drugs not yet available in Canada for an urgent public health need

Health Canada has proposed regulations that will amend the Food and Drug Regulations to allow for importation of drugs that have not yet received regulatory approval from Health Canada. The new regulations will provide access to drugs that address an urgent public health need provided they have been approved in the United States, the European … Continue reading

FCA finds no failure to mitigate Apotex damages claim against Health Canada for delayed Apo-Trazodone NOC

Case: Apotex Inc v Her Majesty the Queen, 2017 FCA 73 (Court File No. A-553-14/A-554-14) Drug: Apo-Trazodone Nature of case: Appeal of action for damages in tort and breach of contract Successful party: Apotex Inc. (in part) Date of decision: April 6, 2017 Summary The Federal Court of Appeal allowed Apotex’s appeal, in part, from … Continue reading
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