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Preparing and submitting summary reports for marketed drugs and natural health products : guidance document for industry.: H164-235/2018E-PDF

"This guidance document provides market authorization holders (MAHs) with information on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to preparing and submitting annual summary reports (ASRs) and issue-related summary reports (IRSRs)"--Scope and Application, p. 1.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.856242&sl=0

Publication information
Department/Agency
  • Canada. Health Canada.
TitlePreparing and submitting summary reports for marketed drugs and natural health products : guidance document for industry.
Variant title
  • Guidance document for industry
Publication typeMonograph
Language[English]
Other language editions[French]
FormatDigital text
Electronic document
Note(s)
  • "Effective Date: May 23, 2018."
  • Title from cover.
  • "Your health and safety ... our priority."
  • "MedEffect Canada. Together we can improve health product safety."
  • The copy has been replaced on January 21, 2022 as requested by the issuing department.
  • Issued also in French under title: Préparation et présentation de rapports de synthèse pour les drogues et les produits de santé naturels commercialisés : document d’orientation à l’intention de l’industrie.
  • Includes bibliographical references.
Publishing information
  • Ottawa : Health Canada, 2018.
Descriptioniii, 25 p.
ISBN978-0-660-26506-3
Catalogue number
  • H164-235/2018E-PDF
Departmental catalogue numberPub.: 180054
Subject terms
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