Amendments to the Food and Drug Regulations were recently issued relating to the labelling and packaging of drug products.1 2 In connection with these amendments, Health Canada and the Institute for Safe Medication Practices Canada have published a draft "Good Label and Package Practice Guide" (Guide) to assist companies in meeting the new labelling requirements and in designing safe and clear labels and packages for drug products.3 The Guide applies to a range of health products for human use, including prescription and non-prescription pharmaceuticals, biologics, radiopharmaceuticals and natural health products.4
What You Need To Know
- Consider human factors. Health product labels and packages should be designed with the user in mind, and with consideration to the environment in which the product will be used. These objectives may be met by engaging in:
- User Testing: user testing should mimic the product use to provide a realistic view of how the label and package will function within the intended environment; and
- Design Planning: design considerations should go beyond stability and ease of manufacturing. The design process should be iterative and include reviewing errors and feedback to continuously improve the label and package.
- Review best practices. The Guide outlines current best practices to consider when designing labels and packaging. Some of these considerations include:
- Type Style and Size: the illegibility of printed information is a contributing factor in health product errors; label information must be legible to users in their real-world environments.
- Use of Abbreviations and Symbols: the use of some abbreviations and symbols to convey health product-related information can be an underlying cause of serious dosing errors. Minimizing the use of abbreviations and symbols is recommended.
- Bilingual Labelling: bilingual labelling may pose readability challenges due to information crowding. Consider bilingual labelling early in the development process to accurately determine the amount of label space needed.
- Key Elements on the Principal Display Panel: the principal display panel of a label is the first interface between the user and a health product so it is vital to consider each specific product, its users, and the environment of use to determine what information may be needed to ensure safe use.
- Packaging: the Guide provides specific guidance on packaging for pediatric products, blister packaging, transdermal patches, etc.
Health Canada is soliciting feedback on the Guide until May 4, 2015. For more information on the applicability of the Guide to your health product or to discuss the consultation process, please contact the authors.
1 Government of Canada. Food and Drugs Act. Regulations amending the food and drug regulations (labelling, packaging and brand names of drugs for human use). Available at: http://www.canadagazette.gc.ca/rp-pr/p2/2014/2014-07-02/html/sor-dors158-eng.php.
2 For more on these amendments, see our bulletin, “Canada Introduces Changes to the Requirements for Labelling, Packaging and Brand Names of Drugs.”
3 Government of Canada. Draft Goof Label and Package Practices Guide. March 3, 2015.
4 Natural Health Products (NHP) are not subject to the regulatory amendments, but the Guide also offers best practice guidance for NHP sponsors.
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
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