Regulatory Requirements for Advertising of Health Products

Regulatory Requirements for Advertising of Health Products

August 14, 2019 By

Only health products that Health Canada authorizes for sale in Canada may be advertised. Thankfully, specific requirements exist for advertisements of prescription drugs to consumers for the best interest of the public. Here’s a brief overview of items to consider when putting together an advertising strategy for a health product.

Health Canada is the national regulatory authority for health product advertisements, overseeing regulated advertising activities, and providing policies to regulate marketed health products. The Marketed Health Products Directorate (MHPD), Regulatory Advertising Section is the unit directly involved. The MHPD “leads an evidence-based program that works collaboratively with other organizations to assess health product risks and make regulatory decisions to manage those risks. Once these risks are assessed they are communicated openly and transparently to help Canadians make informed decisions.”

The Directorate also leads the development of regulations for reporting adverse reactions and works closely with international organizations in the harmonization of regulatory systems to facilitate the sharing of information.

Information in a health product advertisement must be true, and not misleading or deceptive.

 

The MHPD will intervene if:

  • They determine an advertisement poses a significant safety concern
  • When a resolution is not achieved through the complaints mechanism used by different independent agencies
  • When a prescription drug is illegally advertised to the general public
  • When an unauthorized health product is promoted

 

Health product advertisements are reviewed and precleared by different independent agencies, depending on the category of product.

  • Advertising material for non-prescription drugs and natural health products directed to consumers is reviewed and precleared by independent agencies that have publicly self-attested to meeting Health Canada’s recommended attestation criteria.
  • Advertising material for all health products (excluding exempted natural health products) directed to health professionals is reviewed and precleared by the Pharmaceutical Advertising Advisory Board (PAAB), an independent agency recognized by Health Canada.
  • Advisory opinions on messages directed to consumers for prescription drugs, and on educational material discussing a medical condition/disease, are reviewed to ensure that they meet the regulatory requirements by both the PAAB and Advertising Standards Canada (ASC). Both agencies provide advisory opinions on advertising materials and messages in this category.

 

It’s very important that brand owners make sure their advertising materials are fully compliant with the Food and Drug Regulations and other relevant statutes. The last thing you need is negative publicity surrounding your product if Health Canada determines your advertising is misleading or deceptive. If you have any questions or need assistance reviewing your advertising materials, including product labels, please contact us. We ensure the safety, quality, and compliance of natural health products.

 

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. When launching a product in Canada, dicentra can assist you in determining whether your product meets the definition of a food or a natural health product and advise of the requirements and timelines for each category. dicentra can help your accelerated business growth by ensuring you have a clear-cut path to market and avoid costly reformulation or border issues before a non-compliant product is launched.