<?xml version="1.0" encoding="UTF-8"?><marc:collection xmlns:marc="http://www.loc.gov/MARC21/slim">
  <marc:record>
    <marc:leader>00000nam  2200000za 4500</marc:leader>
    <marc:controlfield tag="001">9.856647</marc:controlfield>
    <marc:controlfield tag="003">CaOODSP</marc:controlfield>
    <marc:controlfield tag="005">20221107155559</marc:controlfield>
    <marc:controlfield tag="006">m     o  d f      </marc:controlfield>
    <marc:controlfield tag="007">cr |||||||||||</marc:controlfield>
    <marc:controlfield tag="008">180515s2018    onc     o    f000 0 eng d</marc:controlfield>
    <marc:datafield tag="020" ind1=" " ind2=" ">
      <marc:subfield code="a">9780660266022</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="040" ind1=" " ind2=" ">
      <marc:subfield code="a">CaOODSP</marc:subfield>
      <marc:subfield code="b">eng</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="043" ind1=" " ind2=" ">
      <marc:subfield code="a">n-cn---</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="086" ind1="1" ind2=" ">
      <marc:subfield code="a">H13-9/12-2018E-PDF</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="245" ind1="0" ind2="0">
      <marc:subfield code="a">Guidance document </marc:subfield>
      <marc:subfield code="h">[electronic resource] : </marc:subfield>
      <marc:subfield code="b">post‐notice of compliance (NOC) changes : quality document.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="246" ind1="3" ind2="0">
      <marc:subfield code="a">Post‐notice of compliance (NOC) changes : </marc:subfield>
      <marc:subfield code="b">quality document</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="246" ind1="1" ind2="7">
      <marc:subfield code="a">Post-NOC quality</marc:subfield>
    </marc:datafield>
    <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>
    </marc:datafield>
    <marc:datafield tag="300" ind1=" " ind2=" ">
      <marc:subfield code="a">267 p.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Issued also in French under title: Ligne directrice : changements survenus après l'avis de conformité (AC) : document sur la qualité.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Cover title.</marc:subfield>
    </marc:datafield>
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      <marc:subfield code="a">"Publication date: November 2018."</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Issued also in HTML format.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="693" ind1=" " ind2="4">
      <marc:subfield code="a">Drug approval</marc:subfield>
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      <marc:subfield code="b">Health Canada.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="775" ind1="0" ind2="8">
      <marc:subfield code="t">Ligne directrice </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.856648</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="856" ind1="4" ind2="0">
      <marc:subfield code="q">PDF</marc:subfield>
      <marc:subfield code="s">1.40 MB</marc:subfield>
      <marc:subfield code="u">https://publications.gc.ca/collections/collection_2019/sc-hc/H13-9-12-2018-eng.pdf</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="856" ind1="4" ind2=" ">
      <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/drug-products/applications-submissions/guidance-documents/post-notice-compliance-changes/quality-document.html</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="986" ind1=" " ind2=" ">
      <marc:subfield code="a">180091</marc:subfield>
    </marc:datafield>
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