Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. : H164-318/2021E-PDF
"This guidance applies to sponsors of new COVID-19 drug submissions as well as sponsors seeking a Notice of Compliance (NOC) for COVID-19 drugs that received temporary authorization under the Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (ISAD IO). It also applies to new COVID-19 drug establishment licences under the Food and Drug Regulations. This document will help manufacturers prepare a submission for a Notice of Compliance for a COVID-19 drug under the Regulations. It also outlines the process for meeting the post-market regulatory requirements"--page 1.
Lien permanent pour cette publication :
publications.gc.ca/pub?id=9.898414&sl=1
| Ministère/Organisme | Canada. Health Canada, issuing body. |
|---|---|
| Titre | Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. |
| 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 modifications apportées au Règlement sur les aliments et drogues pour les médicaments contre la COVID-19. Includes bibliographical references (pages 30-31). |
| Information sur la publication | [Ottawa] : Health Canada = Santé Canada, 2021. ©2021 |
| Description | 1 online resource (iv, 32 pages) |
| ISBN | 9780660383286 |
| Numéro de catalogue |
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| Numéro de catalogue du ministère | 210010 |
| Descripteurs | COVID-19 Pandemic, 2020- -- Health aspects -- Canada. Pharmaceutical policy -- Canada. |