On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended
Regulatory
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…
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…
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…
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…
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…
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: 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…
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…
Ontario reduces restrictions on ordinary commercial term benefits and private label products


The Ontario Ministry of Health and Long-Term Care (the Ministry) introduced changes to regulations (collectively, the Regulations) made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA).…