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Health Canada Canada

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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Draft Guidance and a Draft Section 66 Agreement Regarding Data Compensation in the Context of Re-Evaluations and Special Reviews - On September 10, 2024, Health Canada's Pest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

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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

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

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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

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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

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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

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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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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

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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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Health Canada proposes amendments to the Food and Drug Regulations and Medical Devices Regulations to modernize framework for...

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On April 15, 2023, Health Canada proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations (together, the “Proposed Amendments”). The Proposed Amendments are intended to modernize the frameworks...more

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New Formaldehyde Standards on Composite Wood Products Imported into, Sold or Manufactured in Canada

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In case you missed it, new limits were introduced on formaldehyde emissions from composite wood products imported into, sold or manufactured in Canada....more

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House of Commons Standing Committee on Health meets for study of the PMPRB

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The Standing Committee on Health (HESA) of the House of Commons met on Thursday, April 27, 2023, to begin its study of the Patented Medicine Prices Review Board (PMPRB). The Committee first heard from the Minister of Health,...more

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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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New Division 11 of the Food and Drug Regulations: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or...

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Update: Health Canada has prepared an overview of its special access programs, and has finalized the Guidance Document: Sale of Drugs - Public or Canadian Armed Forces Health Emergencies. On February 15, 2023, Regulations...more

Dickinson Wright

U.S. Marketing Materials Can and Will Be Used Against You in a Canadian Court

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Health Canada determined that Texas-based LE-VEL BRANDS, LLC (“Le-Vel”), broke the law by selling its weight loss products to Canadians without seeking product licenses for their natural health products. The products had been...more

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