Description

This document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) for prescription products and those administered or obtained through a health professional. Please note that this includes prescription pharmaceutical drugs, biologic drugs (Schedule D), and radiopharmaceuticals (Schedule C).

Resources

Name	Format	Description	Link
Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs - document	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/questions-answers-plain-language-labelling-2019/document.html#s1.1
Questions and Answers: Plain Language Labelling Regulations for Prescription Drugs - document	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/questions-reponses-reglement-etiquetage-langage-clair-2019/document.html#s1

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