News & Analysis as of

Certificates of Supplementary Protection (CSPs) Amended Regulation

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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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Regulatory amendments provide permanent measures to address therapeutic product shortages

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On September 1, 2021, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were published in Part II of the Canada Gazette. These amendments are intended to provide...more

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PMPRB Update: Jurisdiction extends to CSPs effective June 30; coming into force of Patented Medicines Regulations and Guidelines...

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The coming into force of the amended Patented Medicines Regulations has been delayed a third time, now until January 1, 2022. The amendments, once in force, will add new price regulatory factors, revise the list of...more

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Brexit prompts amendment to CSP Regulations

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On December 21, 2020, the Certificate of Supplementary Protection Regulations were amended to add the United Kingdom as a “prescribed country” for the purpose of determining the timeliness of the Certificate of Supplementary...more

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2020 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more

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Amended PM(NOC) Regulations: Third Anniversary Update

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September 21, 2020 marked the third anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations), which heralded significant changes to the litigation landscape for...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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Amended PMNOC Regulations: Second Anniversary Update

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September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more

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2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

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