552 - In the indication for a product has been updated (ie. expanded), can you put a "New" sticker on the front page of the Product Monograph for distribution to HCPs?
Jennifer Carroll last edited by
The product monograph is the Terms of Market Authorization approved by Health Canada. The document itself should not be modified outside of the regulatory process described on the Health Canada website (regarding the processes for each level of change). What you can do is generate a promotional monograph. Promotional monographs should not be labeled as “Product Monograph”; they should be identified as advertising/ promotional systems (APS) with titles similar to “Promotional Monograph”, “Marketing Monograph”, or “Clinical Monograph” and reviewed to approval by the PAAB. Please see Guidance on Promotional Monographs document on the PAAB website (http://www.paab.ca/advisories-guidance.htm) for more information. Note that “new” is a broad and unclear statement. What is new? Is it the product? Is it an indication? Is it a dosage form? Etc… During the PAAB review process, PAAB will ensure your promotional monograph is aligned with the PAAB code.