The product information and/or link must be clearly presented within the main message, as described in Section 7.

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.

With respect to self-care products, the fair balance requirement can be met by inserting the following statements into the APS:

i) For Products with a Product Monograph or Health Canada approved Prescribing Information: “Please consult the Product Monograph [or Prescribing Information] available at websitepage.ca for information to assist in benefit-risk assessment. Always direct the patient to read the label”. This should be followed proximally by a statement that the Terms of Market Authorization is also available upon request through a stated phone number. The indication must appear within the APS.

Note that for electronic APS, the phone number is not required if an electronic link is provided to the Product Monograph. In those cases, the linkage statement should be “Please click here for the Product Monograph available at www.websitepage.ca for information to assist in benefit-risk assessment. Always direct the patient to read the label”. The indication must appear within the APS. See Section 7. 

ii) For Licensed Products Without a Product Monograph or Health Canada approved Prescribing Information: “See Warnings, Cautions, and Directions of Use at websitepage.ca for information to assist in benefit-risk assessment. Always direct the patient to read the label”. This should be followed proximally by a statement that the TMA is also available upon request through a stated phone number. The indication must appear within the APS. See Section 7. 

A link to a website for information on warnings, cautions and directions of use is not required if all relevant text from the Health Canada labeling and product license is included in the APS. See Section 7.2.1.

Note that for electronic APS, the phone number is not required if an electronic link is provided to this risk information. In those cases, the linkage statement should be “Please click here for Warnings, Cautions, and Directions of Use to assist in benefit-risk assessment. Always direct the patient to read the label”. The indication must appear within the APS.

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.

All advertising is subject to Code requirements for risk/benefit balance.

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.