Guidance for market authorization requirements for COVID-19 drugs. : H169-12/2021E-PDF
"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.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.904242&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance for market authorization requirements for COVID-19 drugs. |
| Type de publication | Monographie |
| Langue | [Anglais] |
| Autres langues publiées | [Français] |
| Format | Électronique |
| Document électronique | |
| Note(s) | Issued also in French under title: Lignes directrices sur les exigences relatives aux autorisations de mise en marché des médicaments contre la COVID-19. "Effective date: 2021-10-29." Issued also in HTML format. Includes bibliographical references (page 16). |
| Information sur la publication | Ottawa, ON : Health Canada = Santé Canada, September 2021. ©2021 |
| Description | 1 online resource (ii, 16 pages) |
| ISBN | 9780660406572 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | Pub.: 210396 |
| Descripteurs | Pharmaceutical policy -- Canada. Drug approval -- Canada. COVID-19 (Disease) -- Treatment -- Canada. COVID-19 Pandemic, 2020- -- Health aspects -- Canada. |