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Guidance for market authorization requirements for COVID-19 vaccines.: H14-355/2021E-PDF

"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.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.898409&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance for market authorization requirements for COVID-19 vaccines.
Publication typeMonograph
Language[English]
Other language editions[French]
Earlier editionGuidance for market authorization requirements for COVID-19 vaccines.
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 vaccins contre la COVID-19.
  • Issued also in HTML format.
  • "Pub.: 210014."
  • Includes bibliographical references (page 12).
Publishing information
  • [Ottawa] : Health Canada = Santé Canada, March 2021.
  • ©2021
Description1 online resource (ii, 12 pages)
ISBN9780660383262
Catalogue number
  • H14-355/2021E-PDF
Subject terms
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