000	00000nam 2200000zi 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.|w(CaOODSP)9.894041
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