Guidance document for industry - reporting adverse reactions to marketed health products : Canada Vigilance Adverse Reaction Monitoring Program and database, a program of MedEffect Canada.: H164-33/2011E-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. 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.
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| Department/Agency | Canada. Health Canada. |
|---|---|
| Title | Guidance document for industry - reporting adverse reactions to marketed health products : Canada Vigilance Adverse Reaction Monitoring Program and database, a program of MedEffect Canada. |
| Variant title | Reporting adverse reactions to marketed health products Canada Vigilance Adverse Reaction Monitoring Program and database, a program of MedEffect Canada |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Later edition | Reporting adverse reactions to marketed health products |
| Earlier edition | Guidance document for industry - reporting adverse reactions to marketed health products |
| Format | Electronic |
| Electronic document | |
| Note(s) | "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. |
| Publishing information | [Ottawa?] : Health Canada, 2011. |
| Description | iv, 37 p. |
| ISBN | 978-1-100-17663-5 |
| Catalogue number |
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| Subject terms | Side effects Health hazards Industrial policy |
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