4 - Why can't information from a study be used if the reference appears in the bibliography section of the Product Monograph?

  • All claims must be consistent with the Product Monograph. In the past, we have been advised by Health Canada that the inclusion of a study in a drug submission/bibliography section is not indicative of the approval of all parameters of that study. There must be proof of acceptance of the information evidenced by inclusion in the text of the Product Monograph. We can ask Health Canada for a product monograph interpretation. We have no control over when Health Canada answers and they may ask to see the advertising. The PAAB will not release submission information without the written approval of the submitter.