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    <marc:leader>00000nam  2200000za 4500</marc:leader>
    <marc:controlfield tag="001">9.800062</marc:controlfield>
    <marc:controlfield tag="003">CaOODSP</marc:controlfield>
    <marc:controlfield tag="005">20250730101504</marc:controlfield>
    <marc:controlfield tag="007">cr |||||||||||</marc:controlfield>
    <marc:controlfield tag="008">150421s2018    onc    #ob   f000 0 eng d</marc:controlfield>
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      <marc:subfield code="a">978-0-660-01962-8</marc:subfield>
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      <marc:subfield code="a">CaOODSP</marc:subfield>
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      <marc:subfield code="a">n-cn---</marc:subfield>
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      <marc:subfield code="a">Reporting adverse reactions to marketed health products </marc:subfield>
      <marc:subfield code="h">[electronic resource] : </marc:subfield>
      <marc:subfield code="b">guidance document for industry.</marc:subfield>
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      <marc:subfield code="a">Guidance document for industry</marc:subfield>
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    <marc:datafield tag="260" ind1=" " ind2=" ">
      <marc:subfield code="a">Ottawa : </marc:subfield>
      <marc:subfield code="b">Health Canada, </marc:subfield>
      <marc:subfield code="c">2018.</marc:subfield>
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      <marc:subfield code="a">iv, 37 p.</marc:subfield>
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      <marc:subfield code="a">"Effective Date: May 23, 2018."</marc:subfield>
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      <marc:subfield code="a">Title from cover.</marc:subfield>
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      <marc:subfield code="a">"Your health and safety ... our priority."</marc:subfield>
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      <marc:subfield code="a">"MedEffect Canada. Together we can improve health product safety."</marc:subfield>
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    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Issued also in French under title: Déclaration des effets indésirables des produits de santé commercialisés : document d'orientation à l'intention de l'industrie.</marc:subfield>
    </marc:datafield>
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      <marc:subfield code="a">Includes bibliographical references.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="520" ind1=" " ind2=" ">
      <marc:subfield code="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.</marc:subfield>
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    <marc:datafield tag="692" ind1="0" ind2="7">
      <marc:subfield code="2">gccst</marc:subfield>
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      <marc:subfield code="2">gccst</marc:subfield>
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      <marc:subfield code="2">gccst</marc:subfield>
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      <marc:subfield code="a">Canada. </marc:subfield>
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      <marc:subfield code="t">Déclaration des effets indésirables des produits de santé commercialisés </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.800063</marc:subfield>
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    <marc:datafield tag="794" ind1=" " ind2=" ">
      <marc:subfield code="t">Reporting adverse reactions to marketed health products : </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.953703</marc:subfield>
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      <marc:subfield code="t">Guidance document for industry - reporting adverse reactions to marketed health products </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.694177</marc:subfield>
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      <marc:subfield code="q">PDF</marc:subfield>
      <marc:subfield code="s">849 KB</marc:subfield>
      <marc:subfield code="u">https://publications.gc.ca/collections/collection_2018/sc-hc/H164-33-2018-eng.pdf</marc:subfield>
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    <marc:datafield tag="986" ind1=" " ind2=" ">
      <marc:subfield code="a">Pub.: 180052</marc:subfield>
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