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Federal Court finds that Health Canada breached procedural …

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. Background. Organigram Inc. manufactures Edison Jolts (Jolts), which are cannabis products in lozenge form. Organigram

Actived: 2 days ago

URL: https://www.pharmainbrief.com/2023/09/federal-court-finds-that-health-canada-breached-procedural-fairness-by-relying-on-an-undisclosed-internal-guidance-document/

What is a natural health product

WEBHealth Canada made this finding as part of a Court-ordered redetermination of TWC’s licence application. In the redetermination, the key question was whether Resolve’s …

Category: Health Go Health

Health Canada’s proposed amendments to the Food and Drug …

WEBOn 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 …

Category: Food, Medical Go Health

Health Canada disclosing more information on pending generic …

WEBOn February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. Specifically, for generic …

Category: Health Go Health

Health Canada consults on transition of interim order drugs, …

WEBHealth Canada has published a proposal titled “Consultation on amending the Food and Drug Regulations (FDR) to expedite access to COVID-19 drugs”. The proposed …

Category: Food Go Health

Health Canada releases updated Certificate of Supplementary …

WEBHealth Canada has also updated its fee for CSP applications. Background. A CSP can extend, for up to two years, patent protection for a drug containing a new medicinal …

Category: Health Go Health

Drug advertising: Updated guidance from Health Canada on the

WEBHealth Canada’s stance on the meaning of the “general public” is important, as the FDA and FDR place limits on advertising to the general public. Clinical trial …

Category: Health Go Health

Health Canada reports on a national strategy for rare disease …

WEBHealth 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 …

Category: Health Go Health

Health Canada consults on proposed guidelines for the use of …

WEBHealth 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 …

Category: Health Go Health

Health Canada consulting on draft guidance distinguishing …

WEBHealth Canada is consulting on a draft guidance document entitled The Distinction Between Promotional and Non-promotional Messages and Activities for …

Category: Health Go Health

Health Canada amends regulations to permit

WEBHealth 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 …

Category: Food Go Health

Health Canada consulting on clinical trial requirements and “new …

WEBAs we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced …

Category: Health Go Health

Pharma in Brief Norton Rose Fulbright LLP Pharmaceuticals

WEBBy Christopher A. Guerreiro, Brian R. Daley & Pardeep Heir on February 5, 2024. The Federal Court of Appeal ( FCA) has held that the sale of a single dose of a patented …

Category: Health Go Health

Health Canada releases Guidance Document addressing the Plain …

WEBHealth Canada recently published a new Guidance Document that provides information on how Health Canada interprets and applies the 2014 Regulations Amending the Food …

Category: Food Go Health

Federal Court finds Minister of Health’s refusal to grant CSP based …

WEBSUMMARY. The Federal Court has granted Merck Canada Inc.’s (Merck) application for judicial review of a decision of the Minister of Health (Minister) denying a Certificate of …

Category: Health Go Health

Health Canada issues new Interim Order to prevent bulk …

WEBOn November 27, 2020, the Minister of Health (the Minister) issued the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (the Interim Order), …

Category: Health Go Health

Health Canada consulting on the contents of the Generic …

WEBOn January 7, 2019, Health Canada opened a consultation on whether to include the names of sponsor companies on the generic submissions under review list …

Category: Health Go Health

Health Canada Releases Updated Guidance on Amended …

WEBBy Kristin Wall & Pharma in Brief team on August 13, 2018. As we reported, Canada implemented sweeping amendments to the Patented Medicines (Notice of Compliance) …

Category: Medicine Go Health

Health Canada Provides Guidance on Regulation of Software as a …

WEBOn December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document).The …

Category: Medical Go Health

Health Canada issues Interim Order to address shortages of health

WEBHealth 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 …

Category: Food, Medical Go Health

Health Canada collaborates with international partners to address

WEBHealth Canada recently published a notice to industry detailing its collaborations with international partners during the COVID-19 pandemic. These cooperative efforts aim to …

Category: Health Go Health