Guidance document: Product Monograph (2020) (French, HTML)

View metadata and access the original French HTML file: Guidance document: Product Monograph (2020).

Format

HTML

Access

file-only

Publisher-reported update

2021-07-07

The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content. Health Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission. A product monograph is intended to provide the necessary information for the safe and effective use of a new drug and also to serve as a standard against which all promotion and advertising of the drug can be compared.

Access original file