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Food and Drug Act Canada

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Amendments to Food and Drug Regulations (Exports), Natural Health Products Regulations (Labelling)

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The Federal Government has published the following proposed amending regulations in Part 1 of the Canada Gazette: - Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs): The amendments...more

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Special Access Program and Emergency Drug Release Program amendments in force

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On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more

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Clinical trials relating to COVID-19

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UPDATE: The Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice was made on May 3, 2021 (see Notice here) and repeals the Interim Order respecting clinical trials for...more

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Welcome to Canada! 8 important life sciences IP issues for innovators doing business in Canada

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Spanning 5525 miles, the United States-Canada border is the longest border between any two countries. U.S. goods and services trade with Canada totaled an estimated $718.5 billion in 2018, possibly the largest bilateral trade...more

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COVID-19 Update: CIPO, Federal Courts, Health Canada

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This article was last updated on July 10, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more

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Federal Court dismisses application for judicial review of Health Canada’s refusal to grant NHP licence for BOLUOKE oral...

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Update: On November 2, 2021, the Federal Court of Appeal dismissed C-RNA’s appeal from McHaffie J.’s decision: Canada RNA Biochemical Inc v Canada (Minister of Health), 2021 FCA 213. On June 4, 2020 the Federal Court...more

Smart & Biggar

COVID-19 Update: CIPO, Federal Courts, Health Canada

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This article was last updated on June 26, 2020. In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more

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From regulatory flexibility to reimbursement changes, how Canadian regulators and payers are managing the COVID-19 crisis

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UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more

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2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

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FTC Crackdown on Health Claims for CBD Products and the Canadian Side of the Story

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The U.S. Federal Trade Commission (FTC) announced last week it had sent warning letters to three companies advertising cannabidiol products with unproven claims that their products were able to treat or cure serious ailments...more

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Rx IP Update - April 2019

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PMPRB amendments expected to come into force no earlier than Spring 2020 - On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief...more

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First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data

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In the first case calling upon a court to interpret and apply Vanessa’s Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic...more

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Rx IP Update - May 2018

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An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more

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An Update on Vanessa’s Law

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This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act (“FDA”) and granting new powers to...more

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