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020 |a9780660406572
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH169-12/2021E-PDF
24500|aGuidance for market authorization requirements for COVID-19 drugs.
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cSeptember 2021.
264 4|c©2021
300 |a1 online resource (ii, 16 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
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.
500 |a"Effective date: 2021-10-29."
500 |aIssued also in HTML format.
504 |aIncludes bibliographical references (page 16).
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.
650 0|aPharmaceutical policy|zCanada.
650 0|aDrug approval|zCanada.
650 0|aCOVID-19 (Disease)|xTreatment|zCanada.
650 0|aCOVID-19 Pandemic, 2020-|xHealth aspects|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLignes directrices sur les exigences relatives aux autorisations de mise en marché des médicaments contre la COVID-19.|w(CaOODSP)9.904243
85640|qPDF|s1.20 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H169-12-2021-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-drugs.html