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Food & Drug Regulations Health Canada

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Health Canada proposes amendments to the Medical Devices Regulations to address future public health emergencies

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Health Canada has proposed amendments to the Medical Devices Regulations (Regulations) that would expand the regulatory framework for COVID-19 medical devices to apply to future public health emergencies...more

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Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices

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UPDATE: The consultation period has been extended until April 26, 2023. On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under...more

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Updates to Health Canada’s regulatory initiatives for 2022-2024, and amendments to Food and Drug Regulations (Exports and...

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Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more

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Restricted drugs now possible through the Special Access Program

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On January 5, 2022, amendments came into force amending the Food and Drug Regulations to allow practitioners to request access to restricted drugs through the Special Access Program (SAP), which was previously prohibited....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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Health Canada – COVID-19 update highlights

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UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more

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Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

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The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

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Proposed amendments to Food and Drug Regulations and the Medical Devices Regulations to publicly release clinical data after...

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Following release of a white paper in March, on December 9, 2017, Health Canada released proposed amendments to the Food and Drug Regulations under which “clinical summaries, reports and supporting data of clinical trials...more

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Rx IP Update - July 2017

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Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

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