Authorized Use: An advertisement is misleading if it suggests that a drug is useful in a broader range of conditions or patients than that which have been approved by Health Canada. The segment of patients for whom the product is authorized should set the context for the corresponding benefits. Also, the indication(s) should be stated in a manner that clearly reflects the Terms of Market Authorization.

Claims and/or quotations in Advertising/Promotion Systems must be consistent with, and within the limitations of, the Health Canada TMA. Any APS containing direct or indirect product claims and/or quotes from scientific literature must include a complete listing of the scientific references. Labelling must be authorized by Health Canada. See Making Comparisons, Section 5, for claims that are of a comparative nature.

Clinical or therapeutic claims must be based on published, peer-reviewed, controlled, and well-designed studies with clinical and statistical significance clearly indicated. Review articles, pooled data, meta-analysis, post-hoc analysis, are generally regarded as not being acceptable evidence in drug advertising. Data included in the TMA may be acceptable. Additionally, high quality meta-analysis and observational studies may be acceptable. Non-clinical claims must be well supported by relevant evidence.

Clinical and therapeutic APS presentations based on the following types of data are required to meet tailored standards outlined in the listed guidance documents:

1. Real-World Evidence (including, but not limited to, observational studies). See the RWE Guidance Document for evidentiary and presentation format considerations.
2. Subjective endpoints from unblinded RCTs. See the Attention Icon Guidance Document for presentation format considerations.  
3. Clinical studies from other jurisdictions where the inactive ingredients differ from the corresponding Canadian version of that product. The therapeutic use evaluated in the study must align with the use approved in Canada for that product. All relevant provisions of the code apply to inclusion of the study within advertising targeted to Canadian health professionals.  See the Attention Icon Guidance Document for presentation format considerations.

All reference materials, both published and unpublished should be the most recent available, consistent with current Canadian medical opinion and practice and be within the limitations of the Health Canada accepted TMA. Canadian guidelines are to be adhered to and only in the event that they are not available see the following for guidance on international guidelines. What Constitutes Current Medical Opinion.

Current literature may be used to supplement information contained in the TMA or provide further verification of relevant information in the TMA.

Literature used to support claims contained in the APS must be consistent with the indications, dosage regimens, and efficacy and safety information contained in the Health Canada TMA.

The compared drugs/products have an authorized indication for use in common, and the comparison is related to that use; or, in addition to the common indication for use, a second authorized indication is claimed as an added benefit of the advertised drug, and

The comparison is drawn between drugs under the same conditions of use (e.g. equivalent part(s) of their authorized dose ranges (maximum vs. maximum dosage), in a similar population, and