Marketing compliance and enforcement

Report a marketing complaint

Health Canada is responsible for compliance and enforcement activities related to the marketing of drugs and devices. We assess whether the advertisements used to market drugs and devices:

• are false, deceptive or misleading
• meet the regulatory requirements

The incident process

We can become aware of incidents of suspected illegal marketing when we:

• receive a complaint directly from:
  • industry 
  • health care providers
  • any other members of the public
• are referred a complaint from an advertising preclearance agency   
• identify the potential advertising issue through our proactive monitoring

The gradual approach to compliance and enforcement involves:

Assessing

An assessment is conducted on each incident to determine whether the marketing is compliant with the relevant:

• policies 
• legislation
• regulations
• guidance documents

Prioritizing

Where non-compliance is found, cases are prioritized based on the type and degree of risk they may pose.

Enforcement Levels

There are 4 levels of enforcement, in which we take these actions:

Level 1

• contacting the party involved to ask them to immediately stop the non-compliant activity. The party will be provided with 10 business days to inform us of the corrective and preventive measures they are implementing. Failure to comply may be considered as willful non-compliance and would escalate enforcement to Level 2.
• talking to the regulated party to clarify issues and expectations
• including the non-compliant activity in the Health Product Advertising Incidents table

Level 2

• publishing a Health Product InfoWatch Article
• issuing an information update, public warning and/or advisory
• initiating regulatory stop-sale, suspension, warning letters and/or seizures of the product in question

Level 3

• issuing an injunction. An injunction is ordered by a judge to:
  • compel someone to do something 
  • prevent or restrain someone from performing an act

Level 4

•  applying Vanessa’s Law powers, for example, prosecution

Some enforcement levels may be applied simultaneously depending on the specifics of the case, particularly for those with: 

• a high degree of risk
• widespread misinformation 

How you can help stop illegal marketing

Report a marketing complaint