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      <marc:subfield code="a">Lot Release Program for schedule D (biologic) drugs : </marc:subfield>
      <marc:subfield code="b">revised guidance document for implementation.</marc:subfield>
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      <marc:subfield code="a">Ottawa, ON : </marc:subfield>
      <marc:subfield code="b">Health Canada = Santé Canada, </marc:subfield>
      <marc:subfield code="c">April 2026.</marc:subfield>
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      <marc:subfield code="c">©2026</marc:subfield>
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      <marc:subfield code="a">Issued also in French under title: Lignes directrices sur le Programme d'autorisation de mise en circulation des lots de drogues visées à l'annexe D (produits biologiques) : lignes directrices révisées pour la mise en œuvre.</marc:subfield>
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      <marc:subfield code="a">"Pub.: 250442."</marc:subfield>
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      <marc:subfield code="a">"This document outlines the Lot Release Program for Schedule D (biologic) drugs. It also covers the extent of the review and testing of biologic drugs prior to their release for sale in Canada by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD)"--Introduction, page 1.</marc:subfield>
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      <marc:subfield code="e">issuing body.</marc:subfield>
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      <marc:subfield code="t">Lignes directrices sur le Programme d'autorisation de mise en circulation des lots de drogues visées à l'annexe D (produits biologiques) : </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.959620</marc:subfield>
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      <marc:subfield code="q">PDF</marc:subfield>
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      <marc:subfield code="u">https://publications.gc.ca/collections/collection_2026/sc-hc/H164-418-2026-eng.pdf</marc:subfield>
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      <marc:subfield code="q">HTML</marc:subfield>
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      <marc:subfield code="u">https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/lot-release-program-schedule-d-drugs.html</marc:subfield>
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