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| 02211nam 2200409zi 4500 |
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| 001 | 9.904242 |
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| 003 | CaOODSP |
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| 005 | 20221107180505 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 211020e202109##onc ob f000 0 eng d |
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| 020 | |a9780660406572 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH169-12/2021E-PDF |
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| 245 | 00|aGuidance for market authorization requirements for COVID-19 drugs. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cSeptember 2021. |
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| 264 | 4|c©2021 |
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| 300 | |a1 online resource (ii, 16 pages) |
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| 336 | |atext|btxt|2rdacontent |
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| 337 | |acomputer|bc|2rdamedia |
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| 338 | |aonline resource|bcr|2rdacarrier |
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| 500 | |aIssued also in French under title: Lignes directrices sur les exigences relatives aux autorisations de mise en marché des médicaments contre la COVID-19. |
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| 500 | |a"Effective date: 2021-10-29." |
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| 500 | |aIssued also in HTML format. |
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| 504 | |aIncludes bibliographical references (page 16). |
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| 520 | |a"This document provides guidance to drug manufacturers seeking authorization for their drug manufactured, sold, or represented for use in relation to COVID-19. This guidance should be read along with the guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. The guidance explains recent changes to the regulatory process for new COVID-19 drugs"--Page 1. |
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| 650 | 0|aPharmaceutical policy|zCanada. |
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| 650 | 0|aDrug approval|zCanada. |
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| 650 | 0|aCOVID-19 (Disease)|xTreatment|zCanada. |
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| 650 | 0|aCOVID-19 Pandemic, 2020-|xHealth aspects|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLignes directrices sur les exigences relatives aux autorisations de mise en marché des médicaments contre la COVID-19.|w(CaOODSP)9.904243 |
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| 856 | 40|qPDF|s1.20 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H169-12-2021-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-drugs.html |
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