<?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">9.894118</marc:controlfield>
    <marc:controlfield tag="003">CaOODSP</marc:controlfield>
    <marc:controlfield tag="005">20230925103305</marc:controlfield>
    <marc:controlfield tag="006">m     o  d f      </marc:controlfield>
    <marc:controlfield tag="007">cr cn|||||||||</marc:controlfield>
    <marc:controlfield tag="008">201127t20212019onc     o    f000 0 eng d</marc:controlfield>
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      <marc:subfield code="a">9780660367620</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>
    </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">H164-305/2021E-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">certificates of supplementary protection.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="246" ind1="1" ind2="0">
      <marc:subfield code="a">Certificates of supplementary protection</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="246" ind1="1" ind2="7">
      <marc:subfield code="a">CSP guidance document</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">2021.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="264" ind1=" " ind2="4">
      <marc:subfield code="c">©2019</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="300" ind1=" " ind2=" ">
      <marc:subfield code="a">1 online resource (25 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">Cover title.</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: 2021/01/06."</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Issued also in French under title: Ligne directrice : certificats de protection supplémentaire.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="520" ind1=" " ind2=" ">
      <marc:subfield code="a">"In agreeing to provisionally apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs"--Introduction, 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">Patent extensions</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>
    </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">Ligne directrice : </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.894119</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="794" ind1=" " ind2=" ">
      <marc:subfield code="t">Guidance document : </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.921627</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="856" ind1="4" ind2="0">
      <marc:subfield code="q">PDF</marc:subfield>
      <marc:subfield code="s">337 KB</marc:subfield>
      <marc:subfield code="u">https://publications.gc.ca/collections/collection_2021/sc-hc/H164-305-2021-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/register-certificates/certificate-supplementary-protection-regulations.html</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="986" ind1=" " ind2=" ">
      <marc:subfield code="a">200313</marc:subfield>
    </marc:datafield>
  </marc:record>
</marc:collection>
