News & Analysis as of

New Regulations Canada Pharmaceutical Industry

Stikeman Elliott LLP

Regulatory Amendments Impacting Drug and Medical Device Recalls Coming Into Force

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On December 17, 2024, recent amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) relating to the recall of drugs and medical devices will come into force....more

Smart & Biggar

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

Smart & Biggar

PMPRB update: New regulations now coming into force July 1, 2022

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The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred for the fourth time, now until July 1, 2022. The news was announced on...more

Smart & Biggar

PMPRB Update — Ringing in the New Year with New Regulations In-Force?

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Update: The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred, once again, until July 1, 2022. Read more on the statement from...more

Smart & Biggar

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

Smart & Biggar

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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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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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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Publication of Final Regulations on Patent Linkage and Term Restoration

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On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017....more

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