<?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">9.957242</marc:controlfield>
    <marc:controlfield tag="003">CaOODSP</marc:controlfield>
    <marc:controlfield tag="005">20260415081038</marc:controlfield>
    <marc:controlfield tag="006">m     o  d f      </marc:controlfield>
    <marc:controlfield tag="007">cr cn|||||||||</marc:controlfield>
    <marc:controlfield tag="008">251110e202511##onc     ob   f000 0 eng d</marc:controlfield>
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      <marc:subfield code="a">9780660796710</marc:subfield>
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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:datafield tag="043" ind1=" " ind2=" ">
      <marc:subfield code="a">n-cn---</marc:subfield>
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      <marc:subfield code="a">H164-272/2025E-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">preparation of regulatory activities in non-eCTD format.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="246" ind1="1" ind2="7">
      <marc:subfield code="a">Guidance document : </marc:subfield>
      <marc:subfield code="b">preparation of RA in non-eCTD format</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="250" ind1=" " ind2=" ">
      <marc:subfield code="a">[November 2025 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">November 2025.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="264" ind1=" " ind2="4">
      <marc:subfield code="c">©2025</marc:subfield>
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      <marc:subfield code="a">1 online resource (38 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>
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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>
    </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 : préparation des activités réglementaires en format non-eCTD.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Title from cover.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">"Effective date: 2025/11/27."</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">"Pub.: 250327"--Page 2.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="504" ind1=" " ind2=" ">
      <marc:subfield code="a">Includes bibliographical references.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="520" ind1=" " ind2=" ">
      <marc:subfield code="a">"This document defines the filing requirements and provides guidance on the structure, content and transmission of regulatory transactions filed in the non-electronic common technical document (non-eCTD) format. …The non-eCTD guidance document was first published in 2015 and has been revised several times to reflect the onboarding of additional product lines to the non-eCTD format. This revision prescribes changes that have resulted since the previous version, stemming from various process implementations, such as the mandatory use of the eCTD format and the mandatory use of Regulatory enrolment process (REP). …"--Introduction, page 6.</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="650" ind1=" " ind2="0">
      <marc:subfield code="a">Disinfection and disinfectants</marc:subfield>
      <marc:subfield code="x">Government policy</marc:subfield>
      <marc:subfield code="z">Canada.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="650" ind1=" " ind2="0">
      <marc:subfield code="a">Veterinary drugs</marc:subfield>
      <marc:subfield code="x">Government 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)9.957241</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="795" ind1=" " ind2=" ">
      <marc:subfield code="t">Guidance document : </marc:subfield>
      <marc:subfield code="b">[May 2024 edition]</marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.868510</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="856" ind1="4" ind2="0">
      <marc:subfield code="q">PDF</marc:subfield>
      <marc:subfield code="s">1.10 MB</marc:subfield>
      <marc:subfield code="u">https://publications.gc.ca/collections/collection_2026/sc-hc/H164-272-2025-eng.pdf</marc:subfield>
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    <marc:datafield tag="986" ind1=" " ind2=" ">
      <marc:subfield code="a">250327</marc:subfield>
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