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Smart & Biggar | Canada | 27 Sep 2023

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

Recently, Health Canada published guidance on factors that contribute to a determination of whether a message or activity regarding a health product is promotional (ie, considered advertising). This guidance was released following Health Canada's July 2019 consultation.
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Lexology PRO | Canada, France, Global, etc. | 15 Sep 2023

Product regulation and liability: key updates and risks (Sep 2023)

The OPDA warns AstraZeneca over misleading claims, Italy reclassifies CBD products, and the UK Government defers new rules that will require packaging manufacturers to cover recycling costs – plus other key updates.
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Smart & Biggar | Canada | 7 Jun 2023

CADTH consultation on time-limited reimbursement initiative and IMC report on what Canada can learn from Europe

The Canadian Agency for Drugs and Technologies in Health has released a consultation document for a proposed process for time-limited reimbursement recommendations. The initiative aims to help ensure timely access to promising new therapies and would better align with conditional regulatory approval. Meanwhile, Innovative Medicines Canada has released a report that outlines various......
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Smart & Biggar | Canada | 3 May 2023

Permanent regulatory framework for covid-19 medical devices now in force

Amendments to the Medical Devices Regulations that create a permanent regulatory framework for covid-19 medical devices recently came into force. The amended regulations are intended to maintain flexibilities and active authorisations granted under Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to covid-19.
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Smart & Biggar | Canada | 19 Apr 2023

Update on biosimilars in Canada – March 2023

This article provides an update on developments regarding biosimilars in Canada, covering approvals, pending submissions, litigation, regulatory issues and market access. Since June 2022, Health Canada has approved four biosimilars, which brings the total biosimilars approved to 51 biosimilars of 16 innovator reference products.
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Smart & Biggar | Canada | 5 Apr 2023

Health Canada's action plan for non-prescription drugs

As part of Health Canada's initiative to update its approach to regulating self-care products, including non-prescription drugs, and as a first step in advance of a regulatory proposal to simplify market access for non-prescription drug products, Health Canada has developed a Non-prescription Drug Action Plan. The action plan introduces policy and operational solutions to remove barriers for......
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Smart & Biggar | Canada | 1 Mar 2023

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

In July 2021, Health Canada announced its intent to amend the Food and Drug Regulations and the Medical Devices Regulations to modernise the regulatory system to permit agile licensing of drugs and medical devices. The proposed amendments to both regulations were recently published for consultation.
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Smart & Biggar | Canada | 24 Feb 2023

Marketing and advertising tips, traps and trends for 2023

Advertisers should be cautious of misleading advertising – particularly in relation to dark patterns, drip pricing, greenwashing and adequate disclosure of material connection when influencers are used. They should also be aware of developments in accessibility requirements, healthwashing concerns and the gatekeeping power of online platforms. This article highlights key tips, traps and......
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Smart & Biggar | Canada | 15 Feb 2023

Health Canada releases new guidance document on clinical evidence requirements for medical devices

Health Canada released a new guidance document, which provides guidance on clinical evidence requirements for class II, III and IV medical devices. Health Canada also released a companion document, which contains examples of different types of devices and outlines when clinical evidence is more likely or less likely to be required.
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Smart & Biggar | Canada | 18 Jan 2023

2022 highlights in Canadian life sciences IP and regulatory law

🕑 14 minutes This article highlights the main developments that took place in the Canadian life sciences industry in 2022. It covers patent decisions on the merits from the Federal Court and the Federal Court of Appeal, along with updates relating to the Patented Medicines (Notice of Compliance) Regulations, the Patented Medicine Prices Review Board, biosimilars and the Competition Bureau,......
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