Description

The purpose of this document is to provide guidance to sponsors to facilitate compliance with the labelling requirements pursuant to sections 3, 9, and 10 of the Food and Drugs Act as well as related provisions of the Food and Drug Regulations and the Controlled Drugs and Substances Act.

Resources

Name	Format	Description	Link
Guidance Document: Labelling of Pharmaceutical Drugs for Human Use	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/labelling-pharmaceutical-drugs-human-use-2014-guidance-document.html
Guidance Document: Labelling of Pharmaceutical Drugs for Human Use	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/etiquetage-medicaments-pharmaceutiques-destines-usage-humains.html#a13

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