00000nam 2200000zi 4500 9.904242 CaOODSP 20250218135236 m o d f cr ||||||||||| 211020e202109##onc ob f000 0 eng d 9780660406572 CaOODSP eng rda CaOODSP n-cn--- H169-12/2021E-PDF Guidance for market authorization requirements for COVID-19 drugs. Ottawa, ON : Health Canada = Santé Canada, September 2021. ©2021 1 online resource (ii, 16 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Lignes directrices sur les exigences relatives aux autorisations de mise en marché des médicaments contre la COVID-19. "Effective date: 2021-10-29." Issued also in HTML format. Includes bibliographical references (page 16). "This document provides guidance to drug manufacturers seeking authorization for their drug manufactured, sold, or represented for use in relation to COVID-19. This guidance should be read along with the guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. The guidance explains recent changes to the regulatory process for new COVID-19 drugs"--Page 1. Pharmaceutical policy Canada. Drug approval Canada. COVID-19 (Disease) Treatment Canada. COVID-19 Pandemic, 2020-2023 Health aspects Canada. Canada. Health Canada, issuing body. Lignes directrices sur les exigences relatives aux autorisations de mise en marché des médicaments contre la COVID-19. (CaOODSP)9.904243 PDF 1.20 MB https://publications.gc.ca/collections/collection_2021/sc-hc/H169-12-2021-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-drugs.html Pub.: 210396