Guidance for market authorization requirements for COVID-19 vaccines.: H14-355/2021E-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.898409&sl=0
| Department/Agency | Canada. Health Canada, issuing body. |
|---|---|
| Title | Guidance for market authorization requirements for COVID-19 vaccines. |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | Guidance for market authorization requirements for COVID-19 vaccines. |
| Format | Electronic |
| Electronic document | |
| Note(s) | Issued also in French under title: Lignes directrices sur les exigences relatives aux autorisations de mise en marché des vaccins contre la COVID-19. Issued also in HTML format. "Pub.: 210014." Includes bibliographical references (page 12). |
| Publishing information | [Ottawa] : Health Canada = Santé Canada, March 2021. ©2021 |
| Description | 1 online resource (ii, 12 pages) |
| ISBN | 9780660383262 |
| Catalogue number |
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| Subject terms | COVID-19 (Disease) -- Vaccination -- Canada. |