309 - Is the definition of "TMA" equivalent to or broader than the Product monograph? Are in-vitro studies on the MOA of a drug or drug components submitted to and reviewed by Health Canada as part of the NDS acceptable for use as supporting reference to non-clinical claims in promotion materials (as data on file) even if the published reference is not in the actual bibliography of references in the PM?
Jennifer Carroll last edited by
A product monograph (PM) is only one example of a terms of market authorization (TMA). For example, the Product License is another form of TMA used for natural health products and homeopathy products. Data on file (DOF) is generally not an acceptable reference to support claims in HCP advertising. In order for PAAB to approve DOF, there must be clear proof of acceptance of the DOF by Health Canada (e.g. inclusion in the PM). We do not presume that all content within the reference in question are approved by Health Canada merely by virtue of being submitted as part of the NDS. For products having a product monograph, the MOA in advertising should be within the limitations of content presented in the product monograph.