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Health & Product Regulatory

Health & Product Regulatory
Health & Product Regulatory
Expertise / Practices / Health & Product Regulatory

Canada is home to a thriving health and regulated product sector, and the Blakes team is accomplished at helping clients navigate through Canada’s complex regulatory regimes. Our clients trust us because of our ability to offer guidance on a broad range of matters, including at the intersection of federal, provincial and local compliance regimes and the unique sales and marketing restrictions governing their products and industries.

Our deep expertise allows us to provide practical, creative, and commercially driven solutions informed by our knowledge of each specific industry sector.

We advise our clients in the following key areas:

  • Product ingredient, composition and standard reviews

  • Product claims and substantiation

  • Facility and product-specific licensing and pre-market approval requirements

  • Post-market reporting and surveillance activities

  • Interacting with regulators (including Health Canada and the Canadian Food Inspection Agency)

  • Packaging and labelling requirements

  • Product-specific advertising restrictions (such as for food, pharmaceutical drugs, medical devices, cosmetics, children’s products, cannabis and vaping products)

  • Product safety, notifications, recalls and duty to warn issues

  • Health-care compliance

We have significant breadth of experience in advising leading Canadian and multinational companies that develop, manufacture and sell highly regulated health products and services, including prescription and over-the-counter pharmaceuticals, medical devices, natural health products, dietary supplements, food, cosmetics, genetic testing, consumer products, as well as the growing cannabis and vaping sector. Our team often acts as an intermediary between companies and regulatory officials (such as Health Canada, the Canadian Food Inspection Agency and provincial regulatory bodies), advising on the interpretation of legislation, administrative and policy matters and public relations challenges. 

Our team is national in scope and includes a substantial presence in our Montréal office that has extensive experience with compliance issues specific to Quebec. We also regularly assist a number of clients with their legislative compliance management obligations and on the francization of businesses.

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Recent Experience
  • Multinational pharmaceutical, medical device, cannabis and vaping companies on regulatory issues, including importation, licensing, product recalls and safety concerns, promotion and sale of products.

  • A major multinational food manufacturer in a successful relaunch of most of its food products, including comparative claims on label, in print, on television and online to promote newly reformulated products.

  • A vaping manufacturer on the successful launch of its products across Canada, including in respect of packaging and labelling, online sales, retail and mass media promotions, and navigating the unique regulatory restrictions governing these products. 

  • Many multinational organizations on all aspects of French language requirements in Quebec.

  • A food manufacturer on requirements related to the new Safe Foods for Canadians Act, including new licensing, safety and traceability requirements.

  • Pharmaceutical, medical device and other health-industry clients on advertising and marketing issues, including direct-to-consumer advertising campaigns, communications to the media, off-label matters, and marketing and advertising activities directed to health-care professionals, including Innovative Medicines Canada, Medtech Canada and PAAB compliance.

  • Pharmaceutical, natural-health product, food and medical device clients with respect to providing regulatory support in various corporate transactions, product liability litigation and securities matters.

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