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Canada Amended Regulation

Smart & Biggar

Regulation to amend mainly the Regulation respecting the language of commerce and business: key takeaways from a recent discussion...

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On January 10, 2024, the Regulation to amend mainly the Regulation respecting the language of commerce and business (the “Draft Regulation”) was published in the Gazette officielle du Québec. The Draft Regulation was eagerly...more

Stikeman Elliott LLP

Regulations Amending the Ability of Foreign Workers to Buy Residential Property in Canada

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On March 27, 2023, the Federal Government of Canada announced amendments to the Regulations accompanying the Prohibition on the Purchase of Residential Property by Non-Canadians Act (together “the Amended Regulations”) which...more

Dorsey & Whitney LLP

Implications of SEC Amendment to Insider Trading Safe Harbor for Canadian Issuers

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On December 14, 2022, the SEC adopted final rules amending Rule 10b5-1, a safe harbor from liability under the U.S. insider trading rules. The safe harbor permits directors, executive officers and others, including issuers,...more

Bergeson & Campbell, P.C.

Canada Amends Hazardous Products Regulations to Align with GHS Revs 7 and 8

On January 4, 2023, the Department of Health in Canada published in the Canada Gazette, Part II the revisions to the Hazardous Products Regulations (HPR). The HPR is the federal level legislation that sets forth the...more

Stikeman Elliott LLP

Patent Rules Amendments In Force as of October 3, 2022, Reflecting Canada’s Commitments Under CUSMA

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On October 3, 2022, the majority of the amendments introduced by the Rules Amending the Patent Rules on June 2, 2022, came into force and effect. The amendments aim to streamline the patent examination process and bring...more

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Draft revised PMPRB Guidelines released for comment by December 5, 2022

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On October 6, 2022, the Patented Medicine Prices Review Board (PMPRB) released its revised draft Guidelines to give effect to the July 1, 2022 amendments to the Patented Medicines Regulations. Submissions are due by December...more

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PM(NOC) Regulations: Five-year anniversary of major amendments

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September 21, 2022, marked the fifth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fifth year...more

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New PMPRB regulations registered, in force July 1, 2022, interim approach to pricing announced

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As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more

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Key Changes to Alberta's Business Corporations Act

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Alberta’s Bill 84, Business Corporations Amendment Act, 2021 (Alberta) received Royal Assent on December 2, 2021, and came into force on May 31, 2022. Bill 84 introduced significant amendments to the Business Corporations...more

Smart & Biggar

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

Stikeman Elliott LLP

First Stage of Competition Act Amendments Released: Canada Joins the Global Chorus With Harsher Antitrust Penalties, Stricter...

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Earlier this year, the Minister of Innovation, Science and Industry announced that amendments to the Competition Act would come in two stages. The first round of changes were revealed in the Budget Implementation Act (the...more

Smart & Biggar

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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Confidential rebate reporting and new price regulatory factors of the amended Patented Medicines Regulations declared invalid by...

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On February 18, 2022, the Court of Appeal of Quebec released its decision in Merck Canada Inc c Procureur général du Canada (2022 QCCA 240). This is the appeal of the Quebec Superior Court decision declaring price and revenue...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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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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PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more

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The Lights Could Go Out on Over-the-Counter Companies on September 28, 2021

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On September 28, 2021, companies trading in the United States over-the-counter securities markets (“OTC Markets”) that do not comply with amended Rule 15c-211 will no longer be eligible for quotation on the OTC Markets,...more

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PMPRB Update: new consultation on PMPRB Guidelines, including revised international price tests

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Update: On October 28, 2021, the PMPRB provided an update on this consultation, announcing that patentees will have at least two reporting periods to comply with any forthcoming changes to either the current Guidelines or the...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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PMPRB proposes to modify Guidelines definition of "gap medicine" to include medicines sold by July 1, 2021

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Update: See our March 30, 2021 article, which reports the outcome of the consultation, and our April 29, 2021 article reporting an update to compliance timelines for Grandfathered and Gap medicines. Further updates, including...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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Amendments to PMPRB Regulations will now be in force July 1, 2021

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Update: See our January 26, 2021 article, which links to the Canada Gazette copy of the further amendments and discusses proposed consequential modifications to the Guidelines definition of “gap medicine” and compliance...more

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Quebec Court finds price and revenue calculation provisions of amended PMPRB Regulations unconstitutional

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Update: The decision has been appealed. On December 18, 2020, the Quebec Superior Court issued its decision from a constitutional challenge to the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act...more

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New Federal Court Guidelines for Complex Proceedings consolidate and update previous guidelines

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Update: The Federal Court updated the Guidelines on May 18, 2021, which can be found here. The Federal Court has released a new consolidated practice direction, Case and Trial Management Guidelines for Complex...more

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