The advertising preclearance system

On this page

• The role of advertising preclearance agencies
• Criteria for agencies reviewing and preclearing advertising material
• Who deals with complaints about health product advertisements
• List of Canadian advertising preclearance agencies

The role of advertising preclearance agencies

To ensure that advertising material meets Canadian regulatory standards for advertisements for drugs and medical devices, advertising preclearance agencies (APAs) provide review and preclearance services.

Independent APAs:

• review and preclear health product advertisements
• provide copy review services to advertisers and advertising agencies to help ensure that the promotional products meet the relevant:
  • regulatory requirements
  • APA’s advertising codes
• provide advisory opinions on messages directed to consumers for:
  • prescription drugs and vaccines
  • education material discussing a medical condition or disease
• assign an approval number and/or authorization to use the APA logo or seal/mark, which signifies the advertising:
  • has been reviewed
  • in the view of the APA involved, complies with the applicable legislation, regulations and APA codes

Criteria for agencies reviewing and preclearing advertising material

Advertising preclearance agencies have to ensure that they comply with Health Canada’s criteria if they want to be recommended by Health Canada. To be recommended, they must possess and make publicly available, in both official languages, their:

• policies
• standards
• procedures

Additional criteria include providing:

• a system for performance evaluation  
• proof of skills and core competencies
• evidence of independence and neutrality
• a system to refer cases to Health Canada 
• an annual reporting system of preclearance activities
• a process to ensure use of only current Health Canada terms of market authorization
• post-publication/post-broadcast audits of the marketplace influenced by its preclearance advice

Who deals with complaints about health product advertisements

Recognized advertising preclearance agencies reviewing and preclearing advertising material directed to health care providers adjudicate complaints related to this type of advertising.

Health Canada adjudicates complaints related to:

• unauthorized health products  
• direct-to-consumer advertising for all health products
• differences between the advertising preclearance agency and the advertiser or complainant

Health Canada publishes a summary table of health products advertising incidents . 

This table:

• is updated on a quarterly basis
• only includes incidents where Health Canada could reasonably conclude non-compliance with applicable laws  

The aim of publishing this table is to:

• encourage industry compliance 
• provide a learning tool for all advertising stakeholders
• complement current practices of:
  • key international regulatory partners 
  • Canadian advertising preclearance agencies (APAs)
• increase our openness and transparency about advertising incidents

You are encouraged to share this information with members of your association if applicable.

For additional information on this initiative, contact the Marketed Health Products Directorate.

List of Canadian advertising preclearance agencies

Different agencies are responsible for the preclearance of different products and different target audiences.

Agencies that preclear advertising material for all health products directed to health care providers

Pharmaceutical Advertising Advisory Board
Commissioner
1305 Pickering Parkway, Suite 300
Pickering, Ontario
L1V 3P2
Telephone: (905) 509-2275
Fax: (905) 509-2486

Agencies that preclear advertising material for non-prescription drugs and natural health products directed to consumers

Ad Standards Canada
Vice President, Advertising Standards Canada Clearance Services
175 Bloor Street East,
South Tower, Suite 1801
Toronto, Ontario
M4W 3R8
Telephone: 416-961-6311
Fax: 416-961-7904

Extreme Reach
Director Canadian Clearances
635 Queen Street East
Suite 200
Toronto, Ontario
M4M 1G4
Telephone: 416-964-7539

Agencies that provide advisory opinions on messages directed to consumers for prescription drugs and on educational material discussing a medical condition or disease

Ad Standards Canada
Vice President, Advertising Standards Canada Clearance Services
175 Bloor Street East,
South Tower, Suite 1801
Toronto, Ontario
M4W 3R8
Telephone: 416-961-6311
Fax: 416-961-7904

Pharmaceutical Advertising Advisory Board
Commissioner
1305 Pickering Parkway, Suite 300
Pickering, Ontario
L1V 3P2
Telephone: 905-509-2275
Fax: 905-509-2486

Disclaimer: This information is provided as a source to consumers and to industry in order to make informed choices when selecting a preclearance agency for the review of advertising material.