00000nam 2200000zi 4500 9.898414 CaOODSP 20250218135235 m o d f cr ||||||||||| 210408t20212021onc ob f00| 0 eng d 9780660383286 CaOODSP eng rda CaOODSP n-cn--- H164-318/2021E-PDF Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. [Ottawa] : Health Canada = Santé Canada, 2021. ©2021 1 online resource (iv, 32 pages) text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Lignes directrices sur les modifications apportées au Règlement sur les aliments et drogues pour les médicaments contre la COVID-19. Includes bibliographical references (pages 30-31). "This guidance applies to sponsors of new COVID-19 drug submissions as well as sponsors seeking a Notice of Compliance (NOC) for COVID-19 drugs that received temporary authorization under the Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (ISAD IO). It also applies to new COVID-19 drug establishment licences under the Food and Drug Regulations. This document will help manufacturers prepare a submission for a Notice of Compliance for a COVID-19 drug under the Regulations. It also outlines the process for meeting the post-market regulatory requirements"--page 1. COVID-19 Pandemic, 2020-2023 Health aspects Canada. Pharmaceutical policy Canada. Canada. Health Canada, issuing body. Lignes directrices sur les modifications apportées au Règlement sur les aliments et drogues pour les médicaments contre la COVID-19. (CaOODSP)9.898415 PDF 1.22 MB https://publications.gc.ca/collections/collection_2021/sc-hc/H164-318-2021-eng.pdf HTML N/A https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/food-drug-regulations-amendments-covid-19.html 210010