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    <marc:controlfield tag="008">220420e202205  onca    o    f000 0 eng d</marc:controlfield>
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      <marc:subfield code="a">CaOODSP</marc:subfield>
      <marc:subfield code="b">eng</marc:subfield>
      <marc:subfield code="e">rda</marc:subfield>
      <marc:subfield code="c">CaOODSP</marc:subfield>
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      <marc:subfield code="a">n-cn---</marc:subfield>
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      <marc:subfield code="a">H164-332/2022E-PDF</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="245" ind1="0" ind2="0">
      <marc:subfield code="a">Guidance to market authorization holders on issuing health product risk communications.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="264" ind1=" " ind2="1">
      <marc:subfield code="a">Ottawa, ON : </marc:subfield>
      <marc:subfield code="b">Health Canada = Santé Canada, </marc:subfield>
      <marc:subfield code="c">May 2022.</marc:subfield>
    </marc:datafield>
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      <marc:subfield code="c">©2022</marc:subfield>
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      <marc:subfield code="a">1 online resource (iii, 17 pages) : </marc:subfield>
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    </marc:datafield>
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      <marc:subfield code="a">text</marc:subfield>
      <marc:subfield code="b">txt</marc:subfield>
      <marc:subfield code="2">rdacontent</marc:subfield>
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    <marc:datafield tag="337" ind1=" " ind2=" ">
      <marc:subfield code="a">computer</marc:subfield>
      <marc:subfield code="b">c</marc:subfield>
      <marc:subfield code="2">rdamedia</marc:subfield>
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      <marc:subfield code="a">online resource</marc:subfield>
      <marc:subfield code="b">cr</marc:subfield>
      <marc:subfield code="2">rdacarrier</marc:subfield>
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    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Issued also in French under title: Orientation à l'intention des détenteur d'une autorisation de mise sur le marché concernant la diffusion des communications des risques liés aux produits de santé.</marc:subfield>
    </marc:datafield>
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      <marc:subfield code="a">"Pub.: 220059."</marc:subfield>
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      <marc:subfield code="a">Issued also in HTML format.</marc:subfield>
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    <marc:datafield tag="520" ind1=" " ind2=" ">
      <marc:subfield code="a">"The purpose of this document is to assist market authorization holders (MAHs) develop and disseminate health product risk communications (HPRCs). The guidance provided in this document is limited to HPRCs. An HPRC is a specific type of risk communication generated using the Health Canada-developed HPRC template and standardized process. HPRCs are designed to clearly and effectively communicate information to health care professionals about new health-related risks associated with marketed health products such as: drugs, medical devices, and natural health products. The guidelines and procedures described in this document assume that a decision to issue an HPRC has already been made. This document doesn't describe the criteria used to determine whether an HPRC is the ideal risk communication tool to address a particular risk"--Overview, page 1.</marc:subfield>
    </marc:datafield>
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      <marc:subfield code="a">Health products</marc:subfield>
      <marc:subfield code="x">Government policy</marc:subfield>
      <marc:subfield code="z">Canada.</marc:subfield>
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      <marc:subfield code="a">Medical supplies</marc:subfield>
      <marc:subfield code="x">Government policy</marc:subfield>
      <marc:subfield code="z">Canada.</marc:subfield>
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      <marc:subfield code="a">Health risk communication</marc:subfield>
      <marc:subfield code="x">Government policy</marc:subfield>
      <marc:subfield code="z">Canada.</marc:subfield>
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      <marc:subfield code="a">Canada. </marc:subfield>
      <marc:subfield code="b">Health Canada, </marc:subfield>
      <marc:subfield code="e">issuing body.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="775" ind1="0" ind2="8">
      <marc:subfield code="t">Orientation à l'intention des détenteur d'une autorisation de mise sur le marché concernant la diffusion des communications des risques liés aux produits de santé.</marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.910381</marc:subfield>
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    <marc:datafield tag="856" ind1="4" ind2="0">
      <marc:subfield code="q">PDF</marc:subfield>
      <marc:subfield code="s">1.30 MB</marc:subfield>
      <marc:subfield code="u">https://publications.gc.ca/collections/collection_2022/sc-hc/H164-332-2022-eng.pdf</marc:subfield>
    </marc:datafield>
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      <marc:subfield code="q">HTML</marc:subfield>
      <marc:subfield code="s">N/A</marc:subfield>
      <marc:subfield code="u">https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-market-authorization-holders-on-issuing-health-product-risk-communications.html</marc:subfield>
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      <marc:subfield code="a">220059</marc:subfield>
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