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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Title (French)	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
Geographic Scope	[]
Criticality Level	[]
Sensitivity Level	unrestricted
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Open Canada Date Published	2021-03-30 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
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 Collection	publication
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