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| 02298nam 2200349zi 4500 |
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| 001 | 9.898414 |
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| 003 | CaOODSP |
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| 005 | 20250218135235 |
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| 006 | m o d f |
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| 007 | cr ||||||||||| |
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| 008 | 210408t20212021onc ob f00| 0 eng d |
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| 020 | |a9780660383286 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH164-318/2021E-PDF |
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| 245 | 00|aGuidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. |
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| 264 | 1|a[Ottawa] : |bHealth Canada = Santé Canada, |c2021. |
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| 264 | 4|c©2021 |
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| 300 | |a1 online resource (iv, 32 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 modifications apportées au Règlement sur les aliments et drogues pour les médicaments contre la COVID-19. |
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| 504 | |aIncludes bibliographical references (pages 30-31). |
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| 520 | |a"This guidance applies to sponsors of new COVID-19 drug submissions as well as sponsors seeking a Notice of Compliance (NOC) for COVID-19 drugs that received temporary authorization under the Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (ISAD IO). It also applies to new COVID-19 drug establishment licences under the Food and Drug Regulations. This document will help manufacturers prepare a submission for a Notice of Compliance for a COVID-19 drug under the Regulations. It also outlines the process for meeting the post-market regulatory requirements"--page 1. |
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| 650 | 0|aCOVID-19 Pandemic, 2020-2023|xHealth aspects|zCanada. |
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| 650 | 0|aPharmaceutical policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tLignes directrices sur les modifications apportées au Règlement sur les aliments et drogues pour les médicaments contre la COVID-19.|w(CaOODSP)9.898415 |
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| 856 | 40|qPDF|s1.22 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H164-318-2021-eng.pdf |
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| 856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/food-drug-regulations-amendments-covid-19.html |
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