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Contact: Regulatory Advertising and Risk Communications Section
Health product advertising is considered to be any representation, by any means (e.g. television, radio, Internet, print, etc.), for the purpose of promoting directly or indirectly the sale or distribution of any health product (drugs, natural health products, medical devices, vaccines and biological products, etc.).
Only health products that have been authorized for sale in Canada by the Health Products and Food Branch (HPFB) of Health Canada may be advertised. The advertising must not exceed the terms of market authorization. In addition, specific regulatory provisions exist to limit the type/extent of advertisements of prescription drugs to consumers. Advertising of narcotic and controlled drugs to consumers is prohibited.
Health products which are authorized for sale in Canada bear an eight-digit identification number preceded by a specific acronym. Authorized drugs bear the acronym "DIN" (Drug Identification Number), while authorized natural health products and homeopathic medicines respectively bear the acronyms "NPN" (Natural Product Number) and "DIN-HM" (Drug Identification Number - Homeopathic Medicine).
No. Some messages, depending upon the content and the context in which they are disseminated may be considered non-promotional. These could include press releases, consumer brochures, help-seeking announcements, scientific exhibits and journal articles, if they meet the criteria that are outlined in the Health Canada policy "The Distinction Between Advertising and Other Activities".
No one factor alone determines whether or not a message is advertising. Each message must be assessed individually. The purpose, content and context of the message is examined to determine if the intent is to promote the sale of a health product or to provide information. Other factors which must be considered include how and when the message is being delivered, to whom and by whom and how often the message is being conveyed.
Additional information regarding "The List of Canadian Advertising Preclearance Agencies" and their roles in relation to the Department is located on Health Canada's website.
Advertising preclearance agencies review and preclear advertising material in order to help industry ensure compliance with the regulatory provisions of the Food & Drugs Act and
Regulations, the
Natural Health Products Regulations and the various Health Canada guidance documents and codes of advertising. The regulatory framework is intended to protect the health of Canadians. The agencies also offer independent mechanisms to resolve complaints on advertising for authorized health products.
Health Canada is the national regulatory authority for health product advertisements and bears the ultimate responsibility for enforcing the Food & Drugs Act and related Regulations. Health Canada:
Health Canada may intervene:
Health Canada sets the standards for health product advertising material that is not false, misleading or deceptive. Health Canada reserves the right to enforce the provisions contained in the federal legislation through a national compliance and enforcement program which applies on a risk-based approach.
Although it is not mandatory, various manufacturer associations such as NDMAC and Canada's
Research-Based Pharmaceutical Companies (Rx&D) support pre-clearance by independent advertising preclearance agencies. Health Canada strongly encourages all sponsors to comply with the voluntary preclearance review prior to exposure to health care professionals and consumers.
Advertisers should contact the advertising preclearance agencies listed on the Health Canada website to obtain further information on the format for advertisement submissions and the costs involved.
The first route for adjudication of complaints for authorized health products is through advertising preclearance agencies. More specifically, complaints related to:
Complaints should be submitted to the Health Products and Food Branch Inspectorate (HPFBI) Office responsible for your province (see list in the document "How to Submit a Consumer Complaint") or by calling 1-800-267-9675.
To the extent possible, the following information should be provided when filing a complaint:
Advertising preclearance agencies have complaint adjudication mechanisms in place which outline appropriate corrective actions.
If an advertisement continues to be non-compliant with the Food and Drugs Act and its Regulations, enforcement actions will be undertaken by Health Canada in accordance with the Health Products and Food Branch Compliance and Enforcement Policy.
Advertising guidance documents as well as additional information about health product advertising (reports, consultations, meetings, etc.) are available on the Regulatory Requirements for Advertising section of the Health Canada web site.