Guidance document : product monograph.: H164-299/2020E-PDF

"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. This guidance document supersedes the Guidance Document: Product Monograph (2014) and the Guidance Document: Product Monograph (2016) for all drug product submissions identified under section 1.2 Scope and application"--Introduction, page 8.

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Publication information
Department/Agency Canada. Health Canada, issuing body.
Title Guidance document : product monograph.
Publication type Monograph
Language [English]
Other language editions [French]
Format Electronic
Electronic document
Note(s) Issued also in French under title: Ligne directrice : monographie de produit.
"Publication date: November 2020."
"Pub.: 200165."
Issued also in HTML format.
Includes bibliographical reference.
Publishing information Ottawa, ON : Health Canada = Santé Canada, 2020.
Description 1 online resource (64 pages)
ISBN 9780660358857
Catalogue number
  • H164-299/2020E-PDF
Subject terms Drug approval -- Canada.
Drugs -- Specifications -- Canada.
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