398 - In the current consultation by Health Canada on the Guidance Document: Product Monograph Release Part I: Health Professional Information and Part II: Scientific Information, Health Canada proposes to remove references, as per the response to question 309 , what impact would removal of references have on the utilization of the study by companies if not listed in the PM?


  • Mention of a study in the PM bibliography has no influence on the PAAB review. Given this fact, the removal of the bibliography changes nothing from a PAAB review perspective. As a point of interest, PAAB code section 3.1.2 states that citation in the bibliography section of the Product Monograph does not indicate proof of acceptance by Health Canada.