<?xml version="1.0" encoding="UTF-8"?><marc:collection xmlns:marc="http://www.loc.gov/MARC21/slim">
  <marc:record>
    <marc:leader>00000nam  2200000zi 4500</marc:leader>
    <marc:controlfield tag="001">9.899805</marc:controlfield>
    <marc:controlfield tag="003">CaOODSP</marc:controlfield>
    <marc:controlfield tag="005">20250630115404</marc:controlfield>
    <marc:controlfield tag="006">m     o  d f      </marc:controlfield>
    <marc:controlfield tag="007">cr |||||||||||</marc:controlfield>
    <marc:controlfield tag="008">210514e202105##onc     o    f000 0 eng d</marc:controlfield>
    <marc:datafield tag="020" ind1=" " ind2=" ">
      <marc:subfield code="a">9780660388793</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:subfield code="e">rda</marc:subfield>
      <marc:subfield code="c">CaOODSP</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">H164-319/2021E-PDF</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="245" ind1="0" ind2="0">
      <marc:subfield code="a">Guidance document : </marc:subfield>
      <marc:subfield code="b">data protection under C.08.004.1 of the food and drug regulations.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="250" ind1=" " ind2=" ">
      <marc:subfield code="a">[May 2021 edition].</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 2021.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="264" ind1=" " ind2="4">
      <marc:subfield code="c">©2021</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="300" ind1=" " ind2=" ">
      <marc:subfield code="a">1 online resource (18 pages)</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="336" ind1=" " ind2=" ">
      <marc:subfield code="a">text</marc:subfield>
      <marc:subfield code="b">txt</marc:subfield>
      <marc:subfield code="2">rdacontent</marc:subfield>
    </marc:datafield>
    <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>
    </marc:datafield>
    <marc:datafield tag="338" ind1=" " ind2=" ">
      <marc:subfield code="a">online resource</marc:subfield>
      <marc:subfield code="b">cr</marc:subfield>
      <marc:subfield code="2">rdacarrier</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Issued also in French under title: Ligne directrice : la protection des données en vertu de l’article C.08.004.1 du règlement sur les aliments et drogues.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">"Date adopted: 2009/03/11; revised date: 2021/04/08; effective date: 2021/05/11."</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="650" ind1=" " ind2="0">
      <marc:subfield code="a">Drug approval</marc:subfield>
      <marc:subfield code="z">Canada.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="650" ind1=" " ind2="0">
      <marc:subfield code="a">Data protection</marc:subfield>
      <marc:subfield code="z">Canada.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="710" ind1="1" ind2=" ">
      <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">Lignes directrice : </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.899806</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="794" ind1=" " ind2=" ">
      <marc:subfield code="t">Guidance document : </marc:subfield>
      <marc:subfield code="b">[June 2025 edition]</marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.948927</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="856" ind1="4" ind2="0">
      <marc:subfield code="q">PDF</marc:subfield>
      <marc:subfield code="s">285 KB</marc:subfield>
      <marc:subfield code="u">https://publications.gc.ca/collections/collection_2021/sc-hc/H164-319-2021-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/guidance-document-data-protection-under-08-004-1-food-drug-regulations.html</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="986" ind1=" " ind2=" ">
      <marc:subfield code="a">Pub.: 210097</marc:subfield>
    </marc:datafield>
  </marc:record>
</marc:collection>
