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Advertising requirements for drugs and medical devices

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Health product advertising

Health product advertising directly or indirectly promotes the sale or use of any health product. This can be done by any means including:

  • print
  • Internet
  • broadcast

Only health products that have been authorized for sale by Health Canada may legally be advertised in Canada. These products include:

  • medical devices
  • prescription drugs    
  • natural health products
  • biologics and biosimilars
  • veterinary health products
  • opioids and other controlled substances

 Additional regulatory restrictions apply to advertisements of:

  • prescription drugs
  • opioids and other controlled substances

It is the responsibility of market authorization holders (manufacturers and distributors) and advertisers to ensure that their advertising complies with the relevant laws.

Preclearance process overview

Industry compliance with advertising preclearance is voluntary for all health products except opioids. Preclearance is mandatory for opioids. We strongly encourage all market authorization holders and advertisers to have the materials for their authorized health products precleared prior to dissemination.

Health Canada's role

Health Canada is the national regulatory authority for health product advertisements. We:

  • administer the:
    • Food and Drugs Act
    • Controlled Drugs and Substances Act
    • related Regulations
  • oversee regulated advertising activities
  • provide policies to regulate marketed health products
  • develop guidelines for the interpretation of the Regulations
  • set standards for health product advertising materials to help advertisers produce messages that are not:
    • false
    • deceptive
    • misleading

Our web-based platform Stop illegal marketing of drugs and devices:

  • raises awareness about illegal marketing of drugs and medical devices
  • educates health care providers on the rules governing health product advertising in Canada
  • provides a quick and easy tool to report suspected misleading marketing practices

Visit the compliance and enforcement page for more details.
Contact the Section for Transparency and Advertising Regulatory Surveillance in Health Canada's Marketed Health Products Directorate at drug-device-marketing@canada.ca.

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2019-08-20

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