Guidance for market authorization requirements for COVID-19 vaccines: Labelling and post-market requirements

The guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 indicates that the plain language labelling requirements for mock-up labels and a brand name assessment package do not apply (C.08.002(2)(j.1) and C.08.002(2)(o)). Although not required, sponsors are invited to provide a brand name assessment should one be available.

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Additional Info

Field	Value
Last Updated	April 17, 2026, 22:08 (UTC)
Created	April 17, 2026, 22:08 (UTC)
criticality_level	[]
geographic_scope	[]
open_canada_collection	publication
open_canada_date_published	2021-03-30 00:00:00
open_canada_keywords	{"fr": ["coronavirus", "COVID-19", "pandémie", "médicaments", "médicaments", "vaccins", "autorisation de mise en marché", "licence", "importation ou vente", "vaccin COVID-19", "exigences en matière d'étiquetage", "exigences post-commercialisation"], "en": ["coronavirus", "COVID-19", "pandemic", "drugs", "medications", "vaccines", "market authorization", "licensing", "importing or selling", "COVID-19 vaccine", "labelling requirements", "post-market requirements"]}
open_canada_subject	["health_and_safety"]
sensitivity_level	unrestricted
title_fr	Lignes directrices sur les exigences relatives aux autorisations de mise en marché des vaccins contre la COVID-19 : Exigences d’étiquetage et de post-commercialisation
update_frequency	as_needed