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Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19.: H164-321/2021E-PDF

"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.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.901231&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19.
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • 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.
  • Issued also in HTML format.
  • Includes bibliographical references.
Publishing information
  • [Ottawa] : Health Canada = Santé Canada, 2021.
  • ©2021
Description1 online resource (i, ii, 34 pages)
ISBN9780660394121
Catalogue number
  • H164-321/2021E-PDF
Departmental catalogue number210152
Subject terms
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