Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Overview

Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Overview 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. 2021-07-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyCOVID-19pandemicCOVID-19 drugamendementFood and Drug Regulationsdrugsmanufacturerssubmissionnotice of compliancepost-market regulatory requirements Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: OverviewHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/food-drug-regulations-amendments-covid-19.html Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: OverviewHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/reglement-aliments-drogues-modifications-covid-19.html

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.

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