000 02445nam  2200361za 4500
0019.694177
003CaOODSP
00520221107134506
007cr |||||||||||
008150407s2011    onc     ob   f000 0 eng d
020 |a978-1-100-17663-5
040 |aCaOODSP|beng
043 |an-cn---
0861 |aH164-33/2011E-PDF
24500|aGuidance document for industry - reporting adverse reactions to marketed health products |h[electronic resource] : |bCanada Vigilance Adverse Reaction Monitoring Program and database, a program of MedEffect Canada.
24610|aReporting adverse reactions to marketed health products
24610|aCanada Vigilance Adverse Reaction Monitoring Program and database, a program of MedEffect Canada
260 |a[Ottawa?] : |bHealth Canada, |c2011.
300 |aiv, 37 p.
500 |a"Effective Date: 2011-03-02"
500 |aTitle from cover.
500 |aIssued 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.
504 |aIncludes bibliographical references.
520 |a"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.
590 |a11-22|b2011-06-03
69207|2gccst|aSide effects
69207|2gccst|aHealth hazards
69207|2gccst|aIndustrial policy
7101 |aCanada. |bHealth Canada.
77508|tDocument d'orientation à l'intention de l'industrie - déclaration des effets indésirables des produits de santé commercialisés |w(CaOODSP)9.638357
794 |tReporting adverse reactions to marketed health products |w(CaOODSP)9.800062
795 |tGuidance document for industry - reporting adverse reactions to marketed health products |w9.692198
85640|qPDF|s276 KB|uhttps://publications.gc.ca/collections/collection_2011/sc-hc/H164-33-2011-eng.pdf