Health Canada Publishes Draft Good Label and Package Practices Guide

On March 3, 2015, Health Canada and the Institute for Safe Medication Practices Canada published a draft guidance document entitled “Good Label and Package Practices Guide” (Guide). The Guide focuses on the labelling and packaging of health products for human use, including prescription and non-prescription pharmaceuticals, biologics, and natural health products (NHP).

The Guide indicates that heath product labels and packages should be designed with the user in mind. The environment in which the product will be used (ie where it will be stocked, selected, and administered) should be considered. To satisfy this recommendation, the Guide suggests user testing in order to mimic the circumstances of a product’s usage and provide a realistic view of how the label and package would be perceived by a user in a particular environment.

The Guide also outlines the current best practices to consider when designing labels and packaging. These key practices include appropriate formatting, bilingual labelling, grouping related information, colour coding products, use of abbreviations and symbols, trade dress and branding, label content, and critical warnings.

Aspects of product labelling that are not covered in the Guide include the naming of health products, layout, content and design of product monographs, other package inclusions, other material distributed with the product (e.g., package inserts, patient medication information, consumer information, and prescribing information).

The Guide is designed to complement Health Canada’s Guidance Document entitled “Labelling of Pharmaceutical Drugs for Human Use and the Labelling Guidance Document for Natural Health Products” and should be read together with the Food and Drugs Act, Food and Drug Regulations, and theNatural Health Products Regulations.

The consultation period for the Guide closed May 4, 2015.

Instructions on how to order the draft Guide are available here.