Guidance for market authorization requirements for COVID-19 drugs.: H169-12/2021E-PDF

"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.

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Publication information
Department/Agency Canada. Health Canada, issuing body.
Title Guidance for market authorization requirements for COVID-19 drugs.
Publication type Monograph
Language [English]
Other language editions [French]
Format Electronic
Electronic document
Note(s) 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).
Publishing information Ottawa, ON : Health Canada = Santé Canada, September 2021.
Description 1 online resource (ii, 16 pages)
ISBN 9780660406572
Catalogue number
  • H169-12/2021E-PDF
Departmental catalogue number Pub.: 210396
Subject terms Pharmaceutical policy -- Canada.
Drug approval -- Canada.
COVID-19 (Disease) -- Treatment -- Canada.
COVID-19 Pandemic, 2020- -- Health aspects -- Canada.
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