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008210408t20212021onc     ob   f000 0 eng d
020 |a9780660383262
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH14-355/2021E-PDF
24500|aGuidance for market authorization requirements for COVID-19 vaccines.
264 1|a[Ottawa] : |bHealth Canada = Santé Canada, |cMarch 2021.
264 4|c©2021
300 |a1 online resource (ii, 12 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 vaccins contre la COVID-19.
500 |aIssued also in HTML format.
500 |a"Pub.: 210014."
504 |aIncludes bibliographical references (page 12).
520 |a"This document provides guidance on developing the evidence and documentation needed to obtain an authorization and licensing for importing or selling COVID-19 vaccine in Canada. 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, which explains recent changes to the regulatory process for new COVID-19 drugs"--About this guidance document, page 1.
650 0|aCOVID-19 (Disease)|xVaccination|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLignes directrices sur les exigences relatives aux autorisations de mise en marché des vaccins contre la COVID-19.|w(CaOODSP)9.898410
795 |tGuidance for market authorization requirements for COVID-19 vaccines.|w9.894041
85640|qPDF|s763 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H14-355-2021-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-vaccines.html