Reporting adverse reactions to marketed health products : guidance document for industry.: H164-33/2018E-PDF

"This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products"--Scope, p. 1.

Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.800062&sl=0

Publication information
Department/Agency Canada. Health Canada.
Title Reporting adverse reactions to marketed health products : guidance document for industry.
Variant title Guidance document for industry
Publication type Monograph
Language [English]
Other language editions [French]
Earlier edition Guidance document for industry - reporting adverse reactions to marketed health products
Format Electronic
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."
Issued also in French under title: Déclaration des effets indésirables des produits de santé commercialisés : document d'orientation à l'intention de l'industrie.
Includes bibliographical references.
Publishing information Ottawa : Health Canada, 2018.
Description iv, 37 p.
ISBN 978-0-660-01962-8
Catalogue number
  • H164-33/2018E-PDF
Departmental catalogue number Pub.: 180052
Subject terms Side effects
Health hazards
Industrial policy
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