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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.890868&sl=0
| 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. ©2020 |
| Description | 1 online resource (64 pages) |
| ISBN | 9780660358857 |
| Catalogue number |
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| Subject terms | Drug approval -- Canada. Drugs -- Specifications -- Canada. |