00000nam 2200000zi 4500 9.898409 CaOODSP 20221107174832 m o d f cr ||||||||||| 210408t20212021onc ob f000 0 eng d 9780660383262 CaOODSP eng rda CaOODSP n-cn--- H14-355/2021E-PDF Guidance for market authorization requirements for COVID-19 vaccines. [Ottawa] : Health Canada = Santé Canada, March 2021. ©2021 1 online resource (ii, 12 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 vaccins contre la COVID-19. Issued also in HTML format. "Pub.: 210014." Includes bibliographical references (page 12). "This document provides guidance on developing the evidence and documentation needed to obtain an authorization and licensing for importing or selling COVID-19 vaccine in Canada. 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, which explains recent changes to the regulatory process for new COVID-19 drugs"--About this guidance document, page 1. COVID-19 (Disease) Vaccination Canada. Canada. Health Canada, issuing body. Lignes directrices sur les exigences relatives aux autorisations de mise en marché des vaccins contre la COVID-19. (CaOODSP)9.898410 Guidance for market authorization requirements for COVID-19 vaccines. (CaOODSP)9.894041 PDF 763 KB https://publications.gc.ca/collections/collection_2021/sc-hc/H14-355-2021-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-vaccines.html