00000nam 2200000zi 4500 9.890868 CaOODSP 20240918093410 m o d f cr cn||||||||| 200825t20202020onc ob f000 0 eng d 9780660358857 CaOODSP eng rda CaOODSP n-cn--- H164-299/2020E-PDF Guidance document : product monograph. Ottawa, ON : Health Canada = Santé Canada, 2020. ©2020 1 online resource (64 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier 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. "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. Drug approval Canada. Drugs Specifications Canada. Canada. Health Canada, issuing body. Ligne directrice : (CaOODSP)9.890870 Guidance document : (CaOODSP)9.943343 PDF 592 KB https://publications.gc.ca/collections/collection_2020/sc-hc/H164-299-2020-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/guidance-document-product-monograph-2020.html