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| 02445nam 2200361za 4500 |
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| 001 | 9.694177 |
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| 003 | CaOODSP |
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| 005 | 20221107134506 |
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| 007 | cr ||||||||||| |
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| 008 | 150407s2011 onc ob f000 0 eng d |
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| 020 | |a978-1-100-17663-5 |
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| 040 | |aCaOODSP|beng |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-33/2011E-PDF |
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| 245 | 00|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. |
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| 246 | 10|aReporting adverse reactions to marketed health products |
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| 246 | 10|aCanada Vigilance Adverse Reaction Monitoring Program and database, a program of MedEffect Canada |
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| 260 | |a[Ottawa?] : |bHealth Canada, |c2011. |
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| 300 | |aiv, 37 p. |
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| 500 | |a"Effective Date: 2011-03-02" |
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| 500 | |aTitle from cover. |
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| 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. |
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| 504 | |aIncludes bibliographical references. |
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| 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. |
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| 590 | |a11-22|b2011-06-03 |
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| 692 | 07|2gccst|aSide effects |
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| 692 | 07|2gccst|aHealth hazards |
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| 692 | 07|2gccst|aIndustrial policy |
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| 710 | 1 |aCanada. |bHealth Canada. |
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| 775 | 08|tDocument d'orientation à l'intention de l'industrie - déclaration des effets indésirables des produits de santé commercialisés |w(CaOODSP)9.638357 |
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| 794 | |tReporting adverse reactions to marketed health products |w(CaOODSP)9.800062 |
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| 795 | |tGuidance document for industry - reporting adverse reactions to marketed health products |w9.692198 |
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| 856 | 40|qPDF|s276 KB|uhttps://publications.gc.ca/collections/collection_2011/sc-hc/H164-33-2011-eng.pdf |
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