News & Analysis as of

Minister of Health Canada Pharmaceutical Industry

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Federal Court of Appeal dismisses appeal relating to Minister of Health’s decision to disclose records pursuant to Access to...

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On November 1, 2023, the Federal Court of Appeal (FCA) dismissed Actial’s appeal from an application for judicial review of the Minister of Health’s decision to disclose records pursuant to a request under the Access to...more

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Minister of Health reasonable in concluding successor second person was entitled to benefit of NOA served by predecessor

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On May 26, 2023, the Minister of Health issued a decision that Biosimilar Collaborations Ireland Limited (BCIL) was entitled to the benefit of a notice of allegation (NOA) served by the previous owner of a new drug submission...more

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Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection

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As previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, following the...more

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2021 PMPRB Annual Report

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On November 21, 2022, the Minister of Health tabled the 2021 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The Report includes information on the PMBRB’s regulatory activities, pharmaceutical sales and...more

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PMPRB releases 2020 Annual Report and April 2022 NEWSletter

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On March 30, 2022, the Minister of Health tabled the 2020 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The 2020 Annual Report outlines the PMPRB’s mandate, structure and regulatory activities and...more

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Slam dunk! New basket of countries for PMPRB reporting remain, controversial amendments to Patented Medicines Regulations dropped

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On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the “Regulations”), originally released on August 18, 2019, would come into force on July 1, 2022 in a...more

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New guidance documents and regulatory amendments regarding therapeutic product shortages

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As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more

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Federal Court sets aside decision by the Minister of Health to issue RUZURGI NOC for the second time

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On March 10, 2022, for the second time, the Federal Court set aside a decision by the Minister of Health (Minister) to issue Médunik Canada (Médunik) a Notice of Compliance (NOC) for its amifampridine product, RUZURGI,...more

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Federal Court remits BELSOMRA CSP timing refusal for redetermination

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On August 9, 2019, the Minister of Health denied Merck’s application for a Certificate of Supplementary Protection (CSP) for Canadian Patent No 2,670,892 relating to the drug suvorexant (Merck’s BELSOMRA). On September 29,...more

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Proposed amendments to Food and Drug Regulations and Medical Devices Regulations would modernize the regulatory system for...

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On July 31, 2021, the Minister of Health provided notice of proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations. The amendments are planned for spring 2022 and are intended to modernize...more

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Federal Court of Appeal confirms Janssen’s SPRAVATO not eligible for data protection

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Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...more

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Federal Court quashes RUZURGI NOC and returns matter to the Minister of Health for redetermination

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Update: On redetermination, Health Canada issued a new notice of compliance for RUZURGI on June 24, 2021. Catalyst and Kye have sought judicial review (Court File No T-1047-21). On May 31, 2021, the Federal Court quashed a...more

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Federal Court of Appeal finds Minister of Health’s refusal to grant a CSP for SHINGRIX is reasonable

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In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court judgment....more

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Transition measures released for Interim Order for COVID-19 drugs

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As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more

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Federal Court denies stay of decision issuing NOC for RUZURGI

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On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc (Catalyst) and KYE Pharmaceuticals Inc (KYE) (collectively, the applicants) for an interlocutory injunction to stay the...more

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Rx IP Update - March 2019

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

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