Guidance document: Product Monograph (2020)

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.

Data and Resources

Additional Info

Field	Value
Last Updated	April 17, 2026, 21:35 (UTC)
Created	April 17, 2026, 21:35 (UTC)
criticality_level	[]
geographic_scope	[]
open_canada_collection	publication
open_canada_date_published	2020-11-01 00:00:00
open_canada_keywords	{"fr": ["Document d'orientation", "monographie de produit", "monographie de produit 2020", "partie intégrante d'une présentation de drogue nouvelle", "informations nécessaires à l'utilisation sûre et efficace d'une drogue nouvelle"], "en": ["Guidance document", "product monograph", "product monograph 2020", "an integral part of a new drug submission", "necessary information for the safe and effective use of a new drug"]}
open_canada_subject	["health_and_safety"]
sensitivity_level	unrestricted
title_fr	Ligne directrice: Monographies de produit (2020)
update_frequency	as_needed