Tag archives: Health Canada

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

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 these products was limited to physicians, dentists, veterinary surgeons and pharmacists. The regulatory amendments were made as part of Canada’s obligations under the Canada–United States–Mexico Agreement (CUSMA) and the passing of the CUSMA Continue Reading

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

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 products.

The Guidance Document, entitled Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs (the Guidance Document), is effective as of April 1, 2020.  It identifies information that will support requirements mandated under the PLL Regulations, and points to other FAQs, … 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 on March 30, 2020.

The Interim Order allows the Minister to permit the exceptional importation and sale of: (1) drugs, including biocide drugs (such as hand sanitizers and disinfectants) but not natural health products (NHPs); (2) medical devices; and (3) foods for … 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 efficacy of products.

The bulletin reminded DEL holders of their obligations to notify or report to Health Canada any events that could have an impact on pharmaceutical operations. Specifically, a DEL holder should notify Health Canada within 15 days if an event occurs that could … 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 Constitutes SaMD

Not all software falls within the scope of the Act and Regulations. The Guidance Document provides current interpretations of what constitutes a “device” or “medical device” in the Act and Regulations (including by reference to the definition … 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 CETA on single-track patent litigation under the newly amended Patented Medicines (Notice of Compliance) Regulations. Further, a number of IP and regulatory developments arose, such as: the potential for a national pharmacare program, advances to the self-care products framework for non-prescription drugs, natural health … 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 Union, or Switzerland. “Urgent public health need” is not a defined term in the regulations, but Health Canada identified treatment of opioid use disorder as a current example of an urgent need.

This scheme does not replace existing programs that provide access to drugs that … 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 the Federal Court decision that found Apotex was entitled to damages for misfeasance of public office and negligence, finding that Apotex was not required to mitigate its damages by providing Health Canada with evidence of bioavailability of Apo-Trazodone based on a comparison to a Canadian … Continue Reading

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