18 - When new data is published outside of the Product Monograph, can this data be used for promotional pieces?
Jennifer Carroll last edited by
Section 3.1 of the PAAB Code of Advertising Acceptance states "Advertising / Promotion systems (APS) must be consistent with, and within the limitations of the Health Canada Terms of Market Authorization" (that includes the product monograph). Section 3.2 states that studies used as references in promotional material should be "within the limitations of the Health Canada accepted product monograph ...". Therefore, if the data are used to support a claim that is not within the limitations of the product monograph, the advertising will not be accepted by the PAAB. As an example: if a product was approved for an indication of reducing blood pressure at x dose and you produced a study that was not in the product monograph but included an evaluation of the product in reducing blood pressure at x dose, the PAAB would accept the advertising. Conversely, if the new study showed a rate of efficacy or safety of 80% and the data in the product monograph showed a different number e.g. 60%, the PAAB would not likely accept the 80% claim.