| 000 | 00000cam 2200000za 4500 |
| 001 | 9.856242 |
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| 003 | CaOODSP |
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| 005 | 20260910154119 |
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| 007 | cr ||||||||||| |
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| 008 | 180507s2018 onc ob f000 0 eng d |
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| 020 | |a978-0-660-26506-3 |
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| 040 | |aCaOODSP|beng |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-235/2018E-PDF |
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| 245 | 00|aPreparing and submitting summary reports for marketed drugs and natural health products |h[electronic resource] : |bguidance document for industry. |
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| 246 | 10|aGuidance document for industry |
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| 250 | |a[May 23, 2018 edition]. |
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| 260 | |aOttawa : |bHealth Canada, |c2018. |
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| 300 | |aiii, 25 p. |
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| 500 | |a"Effective Date: May 23, 2018." |
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| 500 | |aTitle from cover. |
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| 500 | |a"Your health and safety ... our priority." |
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| 500 | |a"MedEffect Canada. Together we can improve health product safety." |
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| 500 | |aThe copy has been replaced on January 21, 2022 as requested by the issuing department. |
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| 500 | |aIssued also in French under title: Préparation et présentation de rapports de synthèse pour les drogues et les produits de santé naturels commercialisés : document d’orientation à l’intention de l’industrie. |
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| 504 | |aIncludes bibliographical references. |
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| 520 | |a"This guidance document provides market authorization holders (MAHs) with information on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to preparing and submitting annual summary reports (ASRs) and issue-related summary reports (IRSRs)"--Scope and Application, p. 1. |
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| 692 | 07|2gccst|aProducts |
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| 692 | 07|2gccst|aReports |
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| 692 | 07|2gccst|aIndustrial policy |
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| 710 | 1 |aCanada. |bHealth Canada. |
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| 775 | 08|tPréparation et présentation de rapports de synthèse pour les drogues et les produits de santé naturels commercialisés |w(CaOODSP)9.856244 |
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| 794 | |tGuidance on preparing and submitting summary reports for marketed drugs and natural health products.|b[September 2026 edition]|w(CaOODSP)9.965559 |
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| 856 | 40|qPDF|s1.18 MB|uhttps://publications.gc.ca/collections/collection_2018/sc-hc/H164-235-2018-eng.pdf |
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| 986 | |aPub.: 180054 |
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