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| 01822nam 2200349za 4500 |
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| 001 | 9.800062 |
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| 003 | CaOODSP |
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| 005 | 20221107134542 |
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| 007 | cr ||||||||||| |
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| 008 | 150421s2018 onc #ob f000 0 eng d |
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| 020 | |a978-0-660-01962-8 |
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| 040 | |aCaOODSP|beng |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-33/2018E-PDF |
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| 245 | 00|aReporting adverse reactions to marketed health products |h[electronic resource] : |bguidance document for industry. |
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| 246 | 10|aGuidance document for industry |
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| 260 | |aOttawa : |bHealth Canada, |c2018. |
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| 300 | |aiv, 37 p. |
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| 500 | |a"Effective Date: May 23, 2018." |
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| 500 | |aTitle from cover. |
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| 500 | |a"Your health and safety ... our priority." |
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| 500 | |a"MedEffect Canada. Together we can improve health product safety." |
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| 500 | |aIssued also in French under title: Déclaration des effets indésirables des produits de santé commercialisés : document d'orientation à l'intention de l'industrie. |
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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"--Scope, p. 1. |
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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|tDéclaration des effets indésirables des produits de santé commercialisés |w(CaOODSP)9.800063 |
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| 795 | ##|tGuidance document for industry - reporting adverse reactions to marketed health products |w9.694177 |
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| 856 | 40|qPDF|s849 KB|uhttps://publications.gc.ca/collections/collection_2018/sc-hc/H164-33-2018-eng.pdf |
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