Overview of the good label and package practices guide for prescription drugs

From: Health Canada

Overview

This best practices guide provides direction to industry on the design of safe and clear health product labels. It applies to prescription drugs.

Table of contents

• 1 Overview of the Guide
  • 1.1 Objective
  • 1.2 Introduction
  • 1.3 Scope
  • 1.4 Content contributing to guide development
• 2 Considering Users and Their Environments
• 3 Designing Labels and Packages for Safety
  • 3.1 Introduction
  • 3.2 Planning the design of labels and packages
  • 3.3 Design and layout
    • 3.3.1 Type style and size
    • 3.3.2 TALLman lettering
    • 3.3.3 Proximity and compatibility of information on the principal display panel
    • 3.3.4 White space
    • 3.3.5 Colour and contrast
    • 3.3.6 Use of abbreviations, symbols, and dose designations
    • 3.3.7 Bilingual labelling
    • 3.3.8 Logo, branding, and trade dress
    • 3.3.9 Permanence
  • 3.4 Label information
    • 3.4.1 Key elements on the principal display panel
    • 3.4.2 Expression of strength
    • 3.4.3 Critical warnings
    • 3.4.4 Expiry date
    • 3.4.5 Lot or batch number
    • 3.4.6 Automated identification (e.g., bar coding)
  • 3.5 Packaging
    • 3.5.1 General packaging considerations
    • 3.5.2 Small containers and small-volume containers
    • 3.5.3 Pediatric products
    • 3.5.4 Blister packaging
    • 3.5.5 Transdermal patches
• Appendix 1 - Glossary
• Appendix 2 - Human Factors Principles and Assessment Methods Relevant to Labelling and Packaging
• Appendix 3 - Product-Use Process Maps
• Appendix 4 - Acknowledgements
• References

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Details and history

Published: June 30, 2016
Updated: May 9, 2019 (administrative edits only)
Consulted: March 2015
Part of topic(s): Plain language labelling regulations, Labelling of prescription drugs for human use