Description

Labelling standards are developed for drugs that have a well characterized safety and efficacy profile under specific conditions of use. A manufacturer may reference a labelling standard in a drug submission when the product and its labelling are consistent with the information set out in the document.

Resources

Name	Format	Description	Link
Non-prescription Drugs: Labelling Standards - Drug Product	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/nonprescription-drugs-labelling-standards.html
Non-prescription Drugs: Labelling Standards - Drug Product	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/medicaments-vente-libre-normes-etiquetages-produits-pharmaceutiques.html

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