Description

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.

Resources

Name	Format	Description	Link
Guidance for market authorization requirements for COVID-19 vaccines: Labelling and post-market requirements	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-vaccines/labelling-post-market-requirements.html
Guidance for market authorization requirements for COVID-19 vaccines: Labelling and post-market requirements	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/ligne-directrices-autorisations-mise-marche-vaccins/exigences-etiquetage-post-commercialisation.html

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