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Articles by John Greiss
Animal Testing Ban For Cosmetics To Come Into Force On December 22, 2023
On December 22, 2023, amendments to the federal Food and Drugs Act1 (F&DA) will come into force effectively prohibiting cosmetic brands from relying on animal testing to support the safety of their products (the amendments). The amendments were introduced as part of the Budget Implementation Act, 2023, No. 1,2 which received royal assent on June 22, 2023.
Federal Court finds Health Canada breached procedural fairness by relying on an undisclosed internal guidance document (Canada)
The Federal Court has held that, in relying on an internal guidance document concerning the classification of health products when issuing a Notice of Non-Compliance, Health Canada had breached procedural fairness.
Federal Court finds that Health Canada breached procedural fairness by relying on an undisclosed internal guidance document
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 Canada only published after rendering its decision. Organigram Inc. manufactures Edison Jolts (Jolts), which are cannabis products in lozenge form.
Updated guidance from Health Canada on the distinction between advertising and other activities for health products (Canada)
Health Canada has released updated guidance on the distinction between advertising and other activities for health products.
Drug advertising: Updated guidance from Health Canada on the distinction between advertising and other activities for health products
On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in nature. Promotional messages and activities are subject to the advertising provisions of the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR).
Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices
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.
Health Canada reports on a national strategy for rare disease drugs
Health Canada has published a report on its public consultation on building a national strategy to address access to drugs for rare diseases. This report follows the Government of Canada’s commitment to create a national strategy for drugs for rare diseases based on recommendations made by the Advisory Council on the Implementation of National Pharmacare.
Food And Drug Regulations Amended: COVID-19 Drugs And Vaccines Transitioned Out Of Interim Order Framework
Canada: Food And Drug Regulations Amended: COVID-19 Drugs And Vaccines Transitioned Out Of Interim Order Framework 14 April 2021 by John Greiss , Sarah Pennington and Kristin Wall Norton Rose Fulbright Canada LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com.
Food and Drug Regulations amended: COVID-19 drugs and vaccines transitioned out of interim order framework
The Food and Drug Regulations (FDR) have been amended to allow for continued expedited review of COVID-19 drugs (including vaccines) while transitioning to authorizations by way of a full notice of compliance (NOC) under the FDR. Certain provisions of the amendments came into force on March 18, 2021, while others will come into force on the date that the IO expires.
Two New Interim Orders Update Previous Orders On Medical Devices And Foreign Products During Pandemic - Food, Drugs, Healthcare, Life Sciences - Canada
Canada: Two New Interim Orders Update Previous Orders On Medical Devices And Foreign Products During Pandemic 06 April 2021 by John Greiss and Kristin Wall Norton Rose Fulbright Canada LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com. The Minister of Health has issued two new interim orders (IOs) regarding authorizations for COVID-19-related products.
Two new interim orders update previous orders on medical devices and foreign products during pandemic
The Minister of Health has issued two new interim orders (IOs) regarding authorizations for COVID-19-related products. The first new order extends interim authorizations for COVID-19 medical devices until transition regulations can be passed. The second new order extends and updates the Minister’s authority to permit the import and sale of foreign drugs, medical devices, and foods for a special dietary purpose to alleviate domestic shortages of those products.
Health Canada Consults On Proposed Guidelines For The Use Of Electronic Media In Prescription Drug Labelling
Canada: Health Canada Consults On Proposed Guidelines For The Use Of Electronic Media In Prescription Drug Labelling 22 March 2021 by Sarah Pennington , John Greiss and Randy Sutton Norton Rose Fulbright Canada LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com.
Health Canada consults on proposed guidelines for the use of electronic media in prescription drug labelling
Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. The intent of the draft guidance document is to describe Health Canada’s expectations for manufacturers who distribute prescription drug information through an electronic means, such as a website or mobile app, that is directly linked to a product’s packaging or label.
Health Canada Consults On Transition Of Interim Order Drugs, Vaccines, And Medical Devices To Permanent Approval Pathways - Food, Drugs, Healthcare, Life Sciences - Canada
Canada: Health Canada Consults On Transition Of Interim Order Drugs, Vaccines, And Medical Devices To Permanent Approval Pathways 08 December 2020 by John Greiss and Kristin Wall Norton Rose Fulbright Canada LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com.
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 COVID-19 (Interim Order for Medical Devices) on March 18, 2020.
Health Canada Issues New Interim Order To Prevent Bulk Exportation Of Prescription Drugs From Canada - Food, Drugs, Healthcare, Life Sciences - Canada
Canada: Health Canada Issues New Interim Order To Prevent Bulk Exportation Of Prescription Drugs From Canada 30 November 2020 by John Greiss and Kristin Wall Norton Rose Fulbright Canada LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com. 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.
Federal Court Weighs In On Mandatory Quarantine Upon Re-entering Canada
To print this article, all you need is to be registered or login on Mondaq.com. To contain the spread of COVID-19, the federal government has imposed a mandatory 14-day quarantine for individuals re-entering Canada, with certain exemptions in place.
Health Canada Finalizes Regulations Relating To Sale Of Veterinary Drugs Under The Emergency Drug Release Program
Canada: Health Canada Finalizes Regulations Relating To Sale Of Veterinary Drugs Under The Emergency Drug Release Program 24 November 2020 by John Greiss and Bryan Walker Norton Rose Fulbright Canada LLP Your LinkedIn Connections with the authors To print this article, all you need is to be registered or login on Mondaq.com. Regulatory amendments to the Food and Drug Regulations and Natural Health Products Regulations were published in Canada Gazette (Part II) on October 14.
Health Canada Finalizes Regulations Relating To Sale Of Unapproved Drugs For Emergency Treatment Under The Special Access Program
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Health Canada finalizes regulations relating to sale of unapproved drugs for emergency treatment under the Special Access Program
Regulatory amendments to the Food and Drug Regulations (FDR) and the Natural Health Products Regulations (NHPR) were published in Canada Gazette (Part II) on October 14, 2020. We previously reported on these changes, which seek to reduce the administrative burden associated with the Special Access Program (SAP) (for human drugs) and the Emergency Drug Release (EDR) (for drugs for veterinary use).
New Interim Order To Address COVID-19-related Drug Shortages In Canada
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New Interim Order to address COVID-19-related drug shortages in Canada
On October 16, 2020, the Minister of Health (the Minister) signed the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to Covid-19 (the IO), which introduces new tools for the Minister to address actual or potential drug shortages caused, or exacerbated, by COVID-19. The scope of the IO excludes shortages of veterinary or natural health products. This IO is the 4th Interim Order to be issued by Health Canada in the context of COVID-19.
New Interim Order To Expedite The Approval Of COVID-19 Drugs And Vaccines
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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 allows for addition of new indications related to COVID-19 that are not included in a currently-marketed product’s authorization.
Ontario Lifts Recommendation To Limit Prescription Dispensing To 30 Days' Supply
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Ontario lifts recommendation to limit prescription dispensing to 30 days’ supply
We previously reported on the Ontario government’s efforts to manage the risk of drug shortages in the early days of the pandemic. Those efforts included a recommendation that pharmacies dispense no more than a 30-days’ supply of medication to patients under the Ontario Drug Benefit (ODB) program.
Publicité Et Commercialisation De Produits De Santé Liés À La Pandémie
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Santé Canada A Pris Un Arrêté D'urgence Pour Endiguer La Pénurie De Produits De Santé
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Considerations When Advertising The Health Benefits Of Your Products
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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.
How Canada is streamlining the food supply chain - The Lawyer's Daily
Bryan Walker Geoff Poelman John Greiss Self-isolation measures and COVID-19 have had a significant impact on the ability of Canada’s grocery stores to keep products on their shelves. In response, the Canadian Food Inspection Agency (CFIA) is suspending a number of low-risk compliance enforcement activities in an effort to alleviate supply disruptions and avoid food waste.
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Html.Raw(Health Canada Issues Interim Order To Address Shortages Of Health Products - Food, Drugs, Healthcare, Life Sciences - Canada)
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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.
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.
Ontario And Quebec Introduce Changes To Pharmacy Practice And Highlight The Drug Supply Chain As An Essential Service
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Ontario introduces formulary changes for generic drugs to mitigate risk of drug shortages
On March 30, 2020, the Ontario government launched two one-day consultations on changes to regulations concerning the listing of generic drug products under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). These consultations end March 31, 2020. Both changes are said to be needed to help mitigate the risk of drug shortages in Ontario during the COVID-19 pandemic.
Ontario and Quebec Introduce Changes to Pharmacy Practice and Highlight the Drug Supply Chain as an Essential Service
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 is limited to no more than a 30-days’ supply.
COVID-19: Health Canada Simplifies Regulatory Requirements For COVID-19-Related Products
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COVID-19: Health Canada simplifies regulatory requirements for COVID-19-related products
Health Canada is taking measures to help expedite the importation and sale of certain licensed products required to combat COVID-19. Expedited review of Health Product Submissions and Applications Health Canada has announced that it will expedite the review of any COVID-19 related vaccines, therapeutic products and other health product submissions and applications.
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 help “flatten the curve”, many interactions between HCPs and companies are moving to the virtual world.
COVID-19: Health Canada Issues Bulletin Confirming Obligations Of DEL Holders
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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.
Should Homeopaths Be Allowed to Self-Regulate?
For all the science geeks, let’s get one thing out of the way: homeopathy is bunk. A homeopathic remedy is about as likely to cure anything as Bill Gates’ poop water will cure C. difficile. Just so that’s out of the way. For some, that’s enough to reject the current effort by the Transitional Council of the College of Homeopaths of Ontario to bring the Homeopathy Act, 2007 into effect this April. This legislation would bring homeopaths under the Regulated Health Professions Act in Ontario.
A Response to Heather Mallick's Column
Everyone makes mistakes. I certainly do; and when I do, I like to be corrected. That means hearing criticisms which are sometimes emotionally delivered. But hey, we’re all human. Conversely and unapologetically, I feel people should want to be corrected when they’re wrong too. And if you say something publicly — like on a blog, Twitter, or other forms of media — then I think it’s fair to expect others to volunteer their criticism.
Physician Activism May be Bad for Healthcare
There has been an increasing number of physician-backed cases that challenge our societal norms and which, I think, do more harm than good in the struggle to advance health law and policies in the current system.
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