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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:
publications.gc.ca/pub?id=9.904242&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance for market authorization requirements for COVID-19 drugs.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
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.
  • ©2021
Description1 online resource (ii, 16 pages)
ISBN9780660406572
Catalogue number
  • H169-12/2021E-PDF
Departmental catalogue numberPub.: 210396
Subject terms
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