Product information in pharmaceutical Advertising / Promotion Systems (APS) must conform to the requirements outlined in Section 7.3 of the Code. Indications for use of a pharmaceutical product must conform to the Health Canada authorized Product Monograph, or, if there is no monograph, the accepted Prescribing Information. If neither of the above exists, the Commissioner will make an evaluation after consultation with the appropriate Health Canada official(s) and clinical consultants.
Product information, when required or when necessary, must form an integral part of the advertising message, which may be accomplished via a reference to a website link in a printed piece or by a direct electronic link to a website.
With respect to self-care healthcare products (such as over the counter, natural health and homeopathic products), if all relevant text from the Health Canada labeling and product license is included in the ad, then prescribing information is not required. Relevant text would include: the medicinal ingredients, the approved use, all cautions & warnings, contraindications, interactions, known adverse reactions and dosing information relating to the use(s) promoted in the APS. Only the uses mentioned (or alluded to) in the APS are required to be disclosed.
Advertising with Product Claim Link to Terms of Market Authorization:
One of the following must appear prominently within the main advertising message of the APS:
- Electronic link(s) to the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant)
- URL(s) for a webpage containing the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) accompanied by a statement that these documents are also available upon request through a stated phone number.
For non-electronic APS, a URL should be presented in the following way: “Please consult the [specify the form of TMA (such as Product Monograph)] available at www.websitepage.ca”. This should be followed proximally by a statement that the TMA is also available upon request through a stated phone number.
Additional URL statement requirements:
- When a risk communication is included within the link destination, the statement must refer to it. For example, “… consult the Product Monograph and Dear Healthcare Professional Letter available at…”
- When study parameters and/or references are relegated to the link destination as described in Section 4.4, the statement must clearly indicate this. For example, “consult the Product Monograph, study parameters, and reference list available at…”
The URL may be supplemented, but not replaced, by an electronic coding system, such as a QR code or a bar code.
7.3.1b An electronic link should be presented in the following way:
“Please click here for [insert the form of TMA (e.g. Product Monograph)]”.
Additional electronic link statement requirements:
- When a risk communication is included within the link destination, the statement must refer to it. For example, “…click here for the Product Monograph and Dear Healthcare Professional Letter available at…”
- When study parameters and/or references are relegated to the link destination as described in Section 4.4, the statement must indicate this. For example, “…click here for the Product Monograph, study parameters, and reference list available at…”
Requirements pertaining to the web link destination
7.3.2a The following link destinations are acceptable:
- The TMA and the risk communication on the Health Canada website. The requirement relating to the TMA can be met by linking to the appropriate database search engine page (such as the Drug Product Database, Licensed Natural Health Products Database). This option may not be available for new products or those having recently undergone TMA revision due to Health Canada delays in posting which are beyond the advertiser’s control. The requirement relating to the risk communication can be met linking to the MedEffect Canada page.
- A direct link to the TMA and the risk communication on the corresponding Canadian gated product website (such as www.productnamePM.ca)
- A direct link to the TMA and the risk communication on the Market Authorization Holder’s corporate website (such as www.companynamePM.ca)
7.3.2b A separate review of the link destination webpage is not required where the contents of that page are limited to the following:
- TMA and risk communications for APS
- Reference list and/or study parameters [s4.4]
- Product logo (without tagline) or the corporate logo
- An optional link to the post-gate homepage when the web link destination is part of a broader site
- Optional branding colour scheme (but no images)
Web link destination pages having additional content (whether text or images) are required to be submitted for PAAB review as a separate APS.
7.3.2c The content on the destination site must be in the same language as the APS.
7.3.2d The Market Authorization Holder is required to ensure that the link and the destination are maintained for the duration of the preclearance period.
7.3.2e Where mandated by the consumer advertising regulations, websites housing any content in addition to the TMA and risk communications must be either be gated or de-indexed from search engines (i.e. such that there is no consumer access through search engine results).
If the site is gated, the URL or electronic link promoted in the APS must bypass the gate such that password entry is not required to access these disclosure documents. The URL and electronic link must therefore be promoted only to HCPs.
Corporate Advertising / Promotion Systems (APS)
These are designed to create and maintain a favorable image of a company, its products and its services. See Section 1.5: Materials Not Subject to PAAB Review
These systems may be used at any time at the discretion of the advertiser but must be submitted for PAAB preclearance prior to publication. They must not contain therapeutic or other claims of product merit or status. They may contain:
- A general statement about the pharmaceutical company, its products and its service(s) and policies.
- A partial or complete list or illustration of products manufactured and/ or distributed by the company, along with their respective therapeutic or pharmacologic classifications
- Product information does not have to accompany corporate advertising.
Editorial Advertising / Promotion Systems (APS)
Editorial advertisements are used to present company opinions on current issues, and disseminate updated information relative to therapeutic or pharmacologic class areas in which the company has a vested interest. This may include objective, balanced and scientifically rigorous information with discussion of therapeutic aspects of, or research related to, drugs. There is no emphasis on information specifically about the sponsor’s product(s). The information on a specific drug is consistent with the current TMA for that drug.
- They comprise company-generated open letters, editorials, congress, conference and meeting reports, etc. published as paid advertising.
- They must be clearly identified as advertising to distinguish them from other editorial presentations.
All such materials must be submitted for preclearance prior to distribution to health professionals.
Publication by the company of single-sponsored editorial reports in compliance with the company’s Health Canada authorized product(s) information is acceptable. In addition to identifying the article as advertising, the author(s) should be identified along with any link to the sponsoring company.
The material may make reference to investigational research and must include a disclaimer that a drug has not been authorized for such use in Canada and other pertinent qualifying information. Data presentations or any claims such as clinical efficacy, safety, dosage and administration for products that have not yet been authorized for marketing (pre-NOC) will not be accepted.
Healthcare Product branding elements should not be used in non-branded APS that contain statements, visuals, and references that would not be accepted in a product APS. All copyright regulations must be respected.