What is a Product Monograph?
A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug. The Product Monograph consists of three sections: • Part 1 – Health Professional Information, i.e., prescribing information; • Part 2 – Scientific Information; and • Part 3 – Consumer Information. Manufacturers (or drug sponsors) are required to develop a detailed Product Monograph in accordance with the Health Canada Guidance to Industry: Product Monograph. Health Canada reviews this Product Monograph as part of the drug review process. When deciding on the wording, there is careful consideration given to the content, language and format used. Once authorized by Health Canada, the Product Monograph is used by the drug manufacturer or sponsor to inform physicians, pharmacists, dentists, nurses an
