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Health Canada

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Amended Recall Requirements for Medical Devices and Pharmaceutical Products in Canada

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Health Canada is making changes (via legislative amendments) to the manner in which medical devices and pharmaceutical products are recalled under the Medical Device Regulations, SOR/98-282 (MDR) and the Food and Drug...more

Stikeman Elliott LLP

The Pharmacare Act Receives Royal Assent

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On October 10, 2024, Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received Royal Assent. This legislation establishes a framework for a national universal pharmacare system, aiming to enhance the...more

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Proposed Changes to the Guidance on Recognized Standards for Medical Devices in Canada

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Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a Draft List of Recognized...more

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Pest Management Regulatory Authority is Seeking Stakeholder Input

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Draft Guidance and a Draft Section 66 Agreement Regarding Data Compensation in the Context of Re-Evaluations and Special Reviews - On September 10, 2024, Health Canada's Pest Management Regulatory Authority (PMRA)...more

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PMRA Publishes Draft Regulations Regarding Disclosure of Confidential Test Data for Consultation

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As noted in our Field Notes blog of earlier this year, the Pest Management Regulatory Agency (PMRA) has now published the draft regulations amending the Pest Control Products Regulations (Strengthening the Regulation of Pest...more

Smart & Biggar

2024 mid-year highlights in Canadian life sciences IP and regulatory law

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In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more

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Launch of pCPA temporary access process

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On April 5, 2024, the pan-Canadian Pharmaceutical Alliance (pCPA) announced that it was ready to accept drugs through the pCPA Temporary Access Process (pTAP) (see our previous article regarding the consultation)....more

Smart & Biggar

Generic Submissions Under Review List Will Identify Generic Filers

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On February 23, 2024, Health Canada announced that it will expand the information available on the Generic Submissions Under Review (GSUR) list to include the following...more

Smart & Biggar

Federal Court of Appeal affirms Minister of Health reasonable in concluding successor second person was entitled to benefit of NOA...

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On May 26, 2023, the Minister of Health determined that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations), including...more

Dechert LLP

Mass Tort Implications of FDA’s First of its Kind State Drug Importation Program

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For the first time, FDA approved a proposal that allows for the importation of Canadian-approved pharmaceuticals into the U.S., the first program of its kind to allow a state’s importation of pharmaceuticals approved by a...more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

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On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

ArentFox Schiff

Merry and Bright: Health Canada Recalls Artificial Christmas Trees for Potential Burn or Fire Hazard

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For folks who can’t wait for Christmas, when to put up their tree can be a dilemma. Should they wait until after Thanksgiving? December 1? Or throw all caution to the wind and put up their decorations as soon as the last...more

Smart & Biggar

Federal Court of Appeal dismisses appeal relating to Minister of Health’s decision to disclose records pursuant to Access to...

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On November 1, 2023, the Federal Court of Appeal (FCA) dismissed Actial’s appeal from an application for judicial review of the Minister of Health’s decision to disclose records pursuant to a request under the Access to...more

Smart & Biggar

Medical Devices updates: Annual performance report, new guiding principles for PCCPs for machine learning-enabled medical devices,...

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Medical Devices Directorate Performance Annual Report - In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides...more

Smart & Biggar

PMPRB news: Upcoming roundtable as first phase of new guidelines consultation, two new appointments

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On October 25, 2023, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. The first phase will include a policy roundtable with stakeholders on...more

Smart & Biggar

Updated and new draft Health Canada guidance documents related to medical devices

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On August 30, 2023, Health Canada opened consultation on its draft pre-market guidance for machine learning-enabled medical devices (MLMD), i.e., medical devices that use machine learning, in whole or in part, to achieve...more

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Federal Court of Appeal upholds Health Canada’s decision to designate Lifestyle Patch a Natural Health Product

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In Le-Vel Brands, LLC v The Attorney General Of Canada, 2023 FCA 177, the Federal Court of Appeal (FCA) held that the Federal Court properly determined that Health Canada reasonably decided that Le-Vel Brands (L-Vel)’s Thrive...more

Smart & Biggar

Health Canada publishes guidance on distinction between advertising and other activities for health products

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Promotional messages and activities regarding a health product are subject to the advertising provisions under the Food and Drugs Act (FDA), the Controlled Drugs and Substances Act and/or their associated regulations. For...more

Bergeson & Campbell, P.C.

Health Canada Begins Consultation on Proposed New Requirements for Consumer Chemical Products under the CCPSA

Health Canada has begun a consultation on a proposal to introduce new requirements for consumer chemical products under the Canada Consumer Product Safety Act (CCPSA). Health Canada states that many substances found in...more

Smart & Biggar

PMPRB publishes annual Meds Pipeline Monitor report

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The Patented Medicine Prices Review Board (PMPRB) recently published its Meds Pipeline Monitor 2022 report, which highlights medicines in the pipeline that may impact future clinical practice and drug spending in Canada if...more

Smart & Biggar

Minister of Health releases statement on drug and other health product shortages

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On June 5, 2023, the Minister of Health released a statement on drug and other health product shortages, providing an update on actions being taken aimed at minimizing shortages and their impacts. ...more

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PMPRB releases proposed amendment to Interim Guidance for comment

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On June 20, 2023, the Patented Medicine Prices Review Board (PMPRB) released a proposal to amend the Interim Guidance, which sets out the approach for reviewing the prices of patented medicines under the July 1, 2022...more

Bennett Jones LLP

The PMRA has Provided Clarity for Data Compensation in the Re-Evaluation and Special Review Contexts

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On June 7, 2023, Health Canada's Pest Management Regulatory Agency (PMRA) published the Regulations Amending the Pest Control Products Regulations (exclusive rights and compensable data) in the Canada Gazette Part II. These...more

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Certificates of Supplementary Protection (CSP)

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On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection. The changes are described as being made to reflect current administrative practices, and to...more

Smart & Biggar

Health Canada publishes revised Guidance Document: Certificates of Supplementary Protection (CSP)

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On May 12, 2023, Health Canada announced the fifth version of the Guidance Document: Certificates of Supplementary Protection....more

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