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. The Regulatory Amendments build upon the regulatory flexibilities introduced in the Interim … Continue reading
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. … Continue reading
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 to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers … Continue reading
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
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
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 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
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
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
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
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
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). These changes will remove the financial caps on ordinary commercial term (OCT) payments made by drug manufacturers to pharmacies and allow … Continue reading
The Ontario Ministry of Health and Long-Term Care (the Ministry) has proposed draft amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act. The proposed changes are intended to reduce technical requirements for listing a product on the Ontario formulary and align policies with industry … Continue reading