000
| 02174nam 2200385zi 4500 |
---|
001 | 9.898409 |
---|
003 | CaOODSP |
---|
005 | 20221107174832 |
---|
006 | m o d f |
---|
007 | cr ||||||||||| |
---|
008 | 210408t20212021onc ob f000 0 eng d |
---|
020 | |a9780660383262 |
---|
040 | |aCaOODSP|beng|erda|cCaOODSP |
---|
043 | |an-cn--- |
---|
086 | 1 |aH14-355/2021E-PDF |
---|
245 | 00|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. |
---|
710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
---|
775 | 08|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 |
---|
856 | 40|qPDF|s763 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H14-355-2021-eng.pdf |
---|
856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-vaccines.html |
---|