364 - Hello, Can text from Part III/Consumer Information of a PM be used as a reference within and HCP directed piece? For example, if we were to define patient types that a product is indicated for and use the language defining such patients from Part III, would this be acceptable in HCP directed materials?

  • For an HCP targeted piece, disease information defining the patient type(s) in which the product is indicated may not come from part III of the PM. For example, the content in Part III is not intended to inform the prescriber (or other HCP) about the breadth/scope/definition of the indication, related outcomes or subpopulations. This information must come from Part I of the PM (specifically the Indication and Clinical Use section). Canadian consensus guidelines can be used to elaborate on place in therapy within the indication parameters set in part I of the PM.