Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. : H164-321/2021E-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.

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