Tag archives: Health Canada

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

By Sarah Pennington and Kristin Wall on August 9, 2021 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. The proposed amendments: 1) authorize the Minister of Health (the Minister) to impose terms and conditions on drug and medical device authorizations and to require a Risk Management Plan (RMP); 2) extend flexibilities currently in use for COVID-19 drugs to … Continue Reading

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

By Sarah Pennington, John Greiss and Kristin Wall on July 22, 2021 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 No. 2) if there is no longer an urgent public health need (UPHN) for those devices. The notice states that there is no longer an UPHN for thermometers and ventilators.

Background

As we reported, IO No. 2 (enacted … Continue Reading

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

By John Greiss and Kristin Wall on November 29, 2020 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 the Minister believes could cause Canadian drug shortages. For example, the US Food and Drug Administration (FDA) published a rule entitled Importation of Prescription Drugs (the US Importation Rule) which permits US pharmacists or wholesalers to bulk import certain … Continue Reading

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

By John Greiss and Kristin Wall on September 22, 2020 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 allows for addition of new indications related to COVID-19 that are not included in a currently-marketed product’s authorization.

Expedited Approval

The Interim Order establishes alternative pathways to the standard regulatory review process which helps expedite the authorization of eligible products.

Manufacturers will be permitted

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

By John Greiss and Randy Sutton on May 5, 2020 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 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

By Sarah Pennington, John Greiss and Randy Sutton on April 15, 2020 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 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

By John Greiss, Randy Sutton and Brian R. Daley on April 13, 2020 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 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

By John Greiss and Randy Sutton on March 5, 2020 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 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)

By Caroline Henrie, David Yi and Jordana Sanft on January 21, 2020 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 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

By Jordana Sanft and Kristin Wall on January 14, 2019 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 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

By Pharma in Brief team on May 2, 2017 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 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

By Kristin Wall and Brian R. Daley on April 21, 2017 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 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