All APS must be accurate, complete and clear so as to promote credibility and trust. Statements or illustrations must not mislead.
Fair balance & TMA link for Schedule Ethical, Schedule D, Schedule Prescription and Controlled Products
The product information and/or link must be clearly presented within the main message, as described in Section 7.
In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible. For example PRARBACE™ (Arbasartin Sodium). The Federal drug schedule is not required to be disclosed for non-prescription products.
The non-proprietary name must be the same as that cited in the Health Canada Terms of Market Authorization.
APS must reflect an attitude of caution with respect to drug usage, with emphasis on rational drug therapy and proper patient selection for the advertised product. The advertising copy should provide sufficient information to permit assessment of risk/benefit in a prominent manner, whereby the prominence of risk information must be comparable to the prominence of benefit in the main body copy.
The advertising message should include reference to the safety profile that is consistent with the Health Canada Terms of Market Authorization.
Special warnings, precautions, clinically significant serious adverse events, Notice of Compliance with Conditions (NOC/c) or use limitations cited in the TMA should be included in the body copy. Boxed messages in Product Monographs for products with NOC/c should be included in the advertising message. Examples include abuse potential for narcotics or CNS agents, or specific directions for use in special patient groups such as the elderly, pediatric, pregnant women, nursing mothers, women of childbearing age, etc.
APS containing claims or quotes that emphasize only positive features of a pharmaceutical product, while ignoring significant negative findings, are not acceptable.
The body copy must contain reference to any negative findings in a prominent manner.
Context. Selective data presentations or claims which distort study findings, or which are out of context with study conclusions, are not acceptable.
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.
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.