News & Analysis as of

Minister of Health Prescription Drugs

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Minister of Health releases statement on drug and other health product shortages

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On June 5, 2023, the Minister of Health released a statement on drug and other health product shortages, providing an update on actions being taken aimed at minimizing shortages and their impacts. ...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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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 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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Quebec Government Announces Shift to Biosimilar Drugs

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On May 18th, Christian Dubé, the Minister of Health and Social Services for Quebec announced that the government will begin a shift in favor of the use of biosimilar drugs. The announcement stated that similar to other...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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JULUCA CSP application remitted to Minister of Health for reconsideration

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UPDATE: On January 13, 2021, the Minister of Health refused the application on reconsideration. Viiv sought but later discontinued a second application for judicial review (T-258-21). In a decision dated July 10, 2020,...more

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National Pharmacare Update: Publication of the final report of the Advisory Council

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On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the Advisory Council on the Implementation of National Pharmacare (the Council) (see also: news...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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