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.
Permanent link to this Catalogue record:
|Department/Agency||Canada. Health Canada, issuing body.|
|Title||Guidance for market authorization requirements for COVID-19 drugs.|
|Other language editions||[French]|
|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)|
|Catalogue number|| |
|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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