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

Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Pre-positioning of COVID-19 drugs A promising COVID-19 drug may be imported into Canada before it receives a Canadian market authorization. This early importation and placement in Canadian facilities is referred to as “pre-positioning.” It facilitates the immediate distribution of the drug upon authorization, making it available to Canadians as early as possible. 2021-07-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyCOVID-19pandemicCOVID-19 drugamendementFood and Drug Regulationsdrugsmanufacturerssubmissionnotice of compliancepre-positioning of COVID-19 drugs Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Pre-positioning of COVID-19 drugsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/food-drug-regulations-amendments-covid-19/pre-positioning-drugs.html Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Pre-positioning of COVID-19 drugsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/reglement-aliments-drogues-modifications-covid-19/prepositionnement-drogues.html

A promising COVID-19 drug may be imported into Canada before it receives a Canadian market authorization. This early importation and placement in Canadian facilities is referred to as “pre-positioning.” It facilitates the immediate distribution of the drug upon authorization, making it available to Canadians as early as possible.

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