John Greiss

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New interim order continues expedited authorization pathway for COVID-19 medical devices

The Minister of Health has issued a new interim order regarding expedited authorizations for COVID-19-related medical devices. Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (IO No. 3) maintains all of the flexibilities of its predecessor, including the consideration of urgent public health needs (UPHN). … Continue reading

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. … Continue reading

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

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

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 … Continue reading

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 … Continue reading

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 … Continue reading

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 … Continue reading

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

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

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 … Continue reading

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 … Continue reading

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 … Continue reading

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. Because the policy resulted in additional dispensing fees … Continue reading

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 … 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 … 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 … Continue reading

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 … Continue reading

Ontario and Quebec Introduce Changes to Pharmacy Practice and Highlight the Drug Supply Chain as an Essential Service

Changes Affecting Ontario 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 … Continue reading

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. Until a vaccine … Continue reading

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 … 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 … Continue reading
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