<?xml version="1.0" encoding="UTF-8"?><marc:collection xmlns:marc="http://www.loc.gov/MARC21/slim">
  <marc:record>
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    <marc:controlfield tag="001">9.899807</marc:controlfield>
    <marc:controlfield tag="003">CaOODSP</marc:controlfield>
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    <marc:controlfield tag="006">m     o  d f      </marc:controlfield>
    <marc:controlfield tag="007">cr |||||||||||</marc:controlfield>
    <marc:controlfield tag="008">210514t20212021onc     o    f00| 0 eng d</marc:controlfield>
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      <marc:subfield code="a">9780660388816</marc:subfield>
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    <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>
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      <marc:subfield code="a">n-cn---</marc:subfield>
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      <marc:subfield code="a">H164-320/2021E-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">patented medicines (notice of compliance) regulations.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="264" ind1=" " ind2="1">
      <marc:subfield code="a">[Ottawa] : </marc:subfield>
      <marc:subfield code="b">Health Canada = Santé Canada, </marc:subfield>
      <marc:subfield code="c">2021.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="264" ind1=" " ind2="4">
      <marc:subfield code="c">©2021</marc:subfield>
    </marc:datafield>
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      <marc:subfield code="a">1 online resource (36 pages)</marc:subfield>
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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>
    </marc:datafield>
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      <marc:subfield code="a">computer</marc:subfield>
      <marc:subfield code="b">c</marc:subfield>
      <marc:subfield code="2">rdamedia</marc:subfield>
    </marc:datafield>
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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>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Issued also in French under title: Ligne directrice : règlement sur les médicaments brevetés (avis de conformité).   </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="500" ind1=" " ind2=" ">
      <marc:subfield code="a">"Effective date: 2021/05/11."</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="520" ind1=" " ind2=" ">
      <marc:subfield code="a">"This guidance document provides information regarding the administration of the PM (NOC) Regulations by the Office of Patented Medicines and Liaison (OPML) within the Office of Submissions and Intellectual Property (OSIP), Resource Management and Operations Directorate (RMOD), Health Canada. It is applicable to drugs that receive a notice of compliance (NOC), including pharmaceutical, biological, radiopharmaceutical and veterinary drugs"--page 7.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="650" ind1=" " ind2="0">
      <marc:subfield code="a">Patent medicines</marc:subfield>
      <marc:subfield code="z">Canada.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="650" ind1=" " ind2="0">
      <marc:subfield code="a">Pharmaceutical 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>
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    <marc:datafield tag="775" ind1="0" ind2="8">
      <marc:subfield code="t">Lignes directrice : </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.899808</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="794" ind1=" " ind2=" ">
      <marc:subfield code="t">Guidance document : </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.946275</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="795" ind1=" " ind2=" ">
      <marc:subfield code="t">Guidance document </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.854770</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="856" ind1="4" ind2="0">
      <marc:subfield code="q">PDF</marc:subfield>
      <marc:subfield code="s">393 KB</marc:subfield>
      <marc:subfield code="u">https://publications.gc.ca/collections/collection_2021/sc-hc/H164-320-2021-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/patented-medicines/notice-compliance-regulations.html</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="986" ind1=" " ind2=" ">
      <marc:subfield code="a">210095</marc:subfield>
    </marc:datafield>
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