Non-prescription Drugs: Labelling Standards - Drug Product

Non-prescription Drugs: Labelling Standards - Drug Product 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. 2021-09-09 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyNon-prescription drugslabelling standardsdrug productsafety and efficacy profilespecific conditions of use Non-prescription Drugs: Labelling Standards - Drug ProductHTML 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 ProductHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/medicaments-vente-libre-normes-etiquetages-produits-pharmaceutiques.html

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.

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