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
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
The draft Guide is open to stakeholder consultation from March
3, 2015 to May 4, 2015.
The preceding is intended as a timely update on Canadian
intellectual property and technology law. The content is
informational only and does not constitute legal or professional
advice. To obtain such advice, please communicate with our offices
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