Health Canada has recently released a draft Good Label and Package Practices Guide for stakeholder consultation. Its purpose is to provide direction enabling sponsors to design clear, effective and safe labels and packages for health products intended for human use, including pharmaceuticals and natural health products.
The draft Guide's most substantive sections advise on the design and layout of product labels; information to be included in such labels; and the design or choice of packaging. Each of these sections is further divided into multiple subsections providing more detailed guidance on such topics as bilingual labelling, "Product Facts" tables and types of packaging material, among many others. Each subsection begins with background information on the particular issues to consider and then lists current good practices in bullet-form.
Generally speaking, the draft Guide's directions are framed as recommendations, rather than requirements. However, the draft Guide complements as well as incorporates more formal labelling and packaging requirements from such authorities as the Food and Drugs Act, the Food and Drug Regulations, the Natural Health Products Regulations and the Québec Charter of the French Language. Recommendations are also drawn from other regulatory documents, professional standards and guidelines, safety literature, documented medication and health product incident reports and experience in Canada and other jurisdictions.
The draft Guide is also permeated by what is referred to as a "human factors"-based approach to design. Sponsors are advised to design product labels and packages with users' perspectives in mind, such as how users will interact with a product to identify it and make decisions about using it. Sponsors are also advised to consider products' environments, such as where and how a product will be stocked, selected and administered. The draft Guide further recommends and describes user testing in these respects during product design development or change.
Health Canada developed the draft Guide in collaboration with the Institute for Safe Medication Practices in Canada and with the input from an expert advisory panel comprising a number of healthcare associations, graphic designers and governmental entities.
The draft Guide is open to stakeholder consultation from March 3, 2015 to May 4, 2015.
For further information, please contact a member of our firm's Marketing & Advertising law group.
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