00000nam 2200000za 4500 9.694177 CaOODSP 20221107134506 cr ||||||||||| 150407s2011 onc ob f000 0 eng d 978-1-100-17663-5 CaOODSP eng n-cn--- H164-33/2011E-PDF Guidance document for industry - reporting adverse reactions to marketed health products [electronic resource] : Canada Vigilance Adverse Reaction Monitoring Program and database, a program of MedEffect Canada. Reporting adverse reactions to marketed health products Canada Vigilance Adverse Reaction Monitoring Program and database, a program of MedEffect Canada [Ottawa?] : Health Canada, 2011. iv, 37 p. "Effective Date: 2011-03-02" Title from cover. Issued also in French under title: Document d'orientation à l'intention de l'industrie - déclaration des effets indésirables des produits de santé commercialisés : Programme et Base de données de surveillance des effets indésirables Canada Vigilance, un programme de MedEffet Canada. Includes bibliographical references. "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. ARs for marketed health products within the scope of this guidance document are to be reported to the Canada Vigilance Adverse Reaction Monitoring Program of the Marketed Health Products Directorate (MHPD) of Health Canada"--Scope, p. 1. 11-22 2011-06-03 gccst Side effects gccst Health hazards gccst Industrial policy Canada. Health Canada. Document d'orientation à l'intention de l'industrie - déclaration des effets indésirables des produits de santé commercialisés (CaOODSP)9.638357 Reporting adverse reactions to marketed health products (CaOODSP)9.800062 Guidance document for industry - reporting adverse reactions to marketed health products (CaOODSP)9.692198 PDF 276 KB https://publications.gc.ca/collections/collection_2011/sc-hc/H164-33-2011-eng.pdf