527 - What is the equivalent of product monographs for NHPs? Is it the Product Label , the Product Insert, or the Evidence Summary Report that we are submitting to Health Canada? For instance, if we want to include some precise figures in the promotional material for HCPs, do we need to include them in the Evidence Summary Report? Also, to obtain the right to have a graph or a table in the promotional material to HCPs, is the mention of the figures enough in the document that acts as an equivalent to the Product Monograph, or do we need to include also the graphs/tables?
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Generally, it is a Product License. The evidence summary report is not accepted as support for claims in NHP advertising. Issuance of license to sell the product in Canada does not necessarily mean that Health Canada has approved all statements in the report. We’d need evidence that Health Canada approved the claims you’d like to use in NHP advertising.
