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Guidance on preparing and submitting summary reports for marketed drugs and natural health products.: H164-235/2026E-PDF

"This guidance document helps market authorization holders (MAHs) and licence holders prepare and submit annual summary reports for drugs and natural health products, interim summary reports for Natural Health Products or issue-related summary reports for drugs that comply with the following: Food and Drugs Act (FDA); Food and Drug Regulations (FDR) or Natural Health Products Regulations (NHPR)"--Overview, page 1.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.965559&sl=0

Publication information
Department/Agency
  • Canada. Health Canada, issuing body.
TitleGuidance on preparing and submitting summary reports for marketed drugs and natural health products.
Variant title
  • At head of title: Health products
Publication typeMonograph
Language[English]
Other language editions[French]
Earlier editionPreparing and submitting summary reports for marketed drugs and natural health products [May 23, 2018 edition]
FormatDigital text
Electronic document
Note(s)
  • Title from cover.
  • Issued also in French under title: Ligne directrice sur la préparation et la présentation des rapports de synthèse pour les drogues et les produits de santé naturels commercialisés.
  • Includes bibliographical references (page 32).
Publishing information
  • [Ottawa] : Health Canada = Santé Canada, September 2026.
  • ©2026
ISBN9781100003825
Catalogue number
  • H164-235/2026E-PDF
Departmental catalogue number260287
Edition
  • [September 2026 edition].
Subject terms
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