Company controlled or prepared branded patient information is information that contains non-promotional material that is consistent with, and in addition to, the Health Canada approved patient information (e.g. the consumer information section of the product monograph, patient insert, approved product labelling). The information should focus on educating patients about particular diseases/conditions and optimal use of the product by the patient for whom it has been prescribed.
This information should address patients’ expectations through encouraging meaningful dialogue between patient and healthcare professional and supplementing this dialogue with the best available evidence-based statements.
All health product information must be consistent with the Terms of Market Authorization (TMA), and should not contain promotional claims.
The Advertising/Promotion Systems (APS) could contain additional sources of health information from standard setting organizations. It should be written in clear, understandable and legible language.
Principles for education on optimal use of the product and diseases/conditions:
- Principle 1: Clarity of message
- Principle 2: Management of expectations
- Principle 3: Evidence-based information