Tag archives: Health Canada

What is a natural health product? Health Canada’s findings upheld by Federal Courts

Photo of Paul JorgensenPhoto of Kristin WallBy Paul Jorgensen and Kristin Wall on Posted in Life sciences and healthcare
In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations.  These distinctions are important as … Continue reading

Federal Court finds that Health Canada breached procedural fairness by relying on an undisclosed internal guidance document

Photo of John GreissPhoto of Paul JorgensenPhoto of Kristin WallBy John Greiss, Paul Jorgensen and Kristin Wall on Posted in Life sciences and healthcare
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 fairness by relying on a product classification factor in an internal guidance document that Health … Continue reading

Health Canada releases updated Certificate of Supplementary Protection guidance

Photo of Sarah PenningtonPhoto of Paul JorgensenPhoto of Kristin WallBy Sarah Pennington, Paul Jorgensen and Kristin Wall on Posted in Pharmaceuticals and life sciences
On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance).  The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative … Continue reading

Canada announces its first-ever national strategy for drugs for rare diseases

Photo of Sarah PenningtonPhoto of Paul JorgensenPhoto of Kristin WallBy Sarah Pennington, Paul Jorgensen and Kristin Wall on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
On March 22, 2023, Canada’s federal government announced its first-ever National Strategy for Drugs for Rare Diseases, including an investment of up to $1.5 billion over three years to help increase drug access and affordability.  Investments made as part of the National Strategy The lion’s share of the federal government’s investment – up to $1.4 … Continue reading

Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices

Photo of John GreissPhoto of Paul JorgensenPhoto of Kristin WallBy John Greiss, Paul Jorgensen and Kristin Wall on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
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 open until March 27, 2023. The Regulatory Amendments build upon the regulatory flexibilities introduced in the Interim … Continue reading

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Photo of Sarah PenningtonPhoto of Kristin WallBy Sarah Pennington and Kristin Wall on Posted in Life sciences and healthcare
On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. … Continue reading

Certain COVID-19 medical devices no longer hold urgent public health need status under Interim Order No. 2

Photo of Sarah PenningtonPhoto of John GreissPhoto of Kristin WallBy Sarah Pennington, John Greiss and Kristin Wall on Posted in Life sciences and healthcare
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

Health Canada issues new Interim Order to prevent bulk exportation of prescription drugs from Canada

Photo of John GreissPhoto of Kristin WallBy John Greiss and Kristin Wall on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
On November 27, 2020, the Minister of Health (the Minister) issued the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (the Interim Order), pursuant to s. 30.1(1) of the Food and Drugs Act. Summary The current Interim Order is a response to international frameworks which allow for bulk importation of drugs from Canada, which … Continue reading

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

Photo of John GreissPhoto of Kristin WallBy John Greiss and Kristin Wall on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
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

Health Canada amends regulations to permit distribution of OTC and NHP samples to general public

Photo of John GreissPhoto of Randy SuttonBy John Greiss and Randy Sutton on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences, Uncategorized
Health Canada has finalized amendments to the Food and Drug Regulations (FDR) and Natural Health Product Regulations (NHPR) to allow for the distribution of samples of non-prescription drugs (NPDs, or “over-the-counter” (OTC) drugs) and natural health products (NHPs) to a larger scope of healthcare professionals as well as the general public. Previously, the distribution of … Continue reading

Health Canada releases Guidance Document addressing the Plain Language Labelling Regulations requirements for non-prescription drug products

Photo of Sarah PenningtonPhoto of John GreissPhoto of Randy SuttonBy Sarah Pennington, John Greiss and Randy Sutton on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
Health Canada recently published a new Guidance Document that provides information on how Health Canada interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) (colloquially known as the Plain Language Labelling Regulations or PLL Regulations) for non-prescription (i.e. over-the-counter or OTC) drug … Continue reading

Health Canada issues Interim Order to address shortages of health products

Photo of John GreissPhoto of Randy SuttonPhoto of Brian R. DaleyBy John Greiss, Randy Sutton and Brian R. Daley on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
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

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

Photo of John GreissPhoto of Randy SuttonBy John Greiss and Randy Sutton on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
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)

Photo of Caroline HenriePhoto of David YiBy Caroline Henrie and David Yi on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
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

Photo of Kristin WallBy Kristin Wall on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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

Photo of Kristin WallPhoto of Brian R. DaleyBy Kristin Wall and Brian R. Daley on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
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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