106 - If the US indication is the same as the Canadian one, but the US Product Monograph is more comprehensive can it be cited instead?

  • PAAB Code section 3.1 states that all claims must be consistent with, and within the limitations of, the Health Canada approved Terms of Market Authorization (TMA) (e.g. product monograph). The US FDA approved Product Monograph would not meet that requirement even if the product's indication is similar in Canada. Question #56 may also be of interest as it is similar to this current question.