On July 2, 2014, amendments to the Food and Drug Regulations
(the Regulations) were issued relating to the labelling and
packaging of drug products. In view of the importance of drug
labels in providing health professionals, patients and consumers
with information relating to the safe and proper use of drugs, the
changes are aimed at emphasizing plain language labelling of drugs
in Canada. These amendments will apply to human non-prescription
and prescription pharmaceutical and biologic drugs for human
The amendments include five targeted requirements:
Plain Language Requirement: The amendments
create a general requirement for clear, understandable plain
language labels. The format or presentation of labels must also not
impede consumer comprehension. Readability of labels can be met by
certain elements, such as clear writing, colour contrast, font size
and layout of text.
Contact Information Requirement: The
amendments also include a requirement that contact information be
placed on labels so that consumers can report medication errors,
injury or other events. Consumers must be provided with a clear and
transparent mechanism to contact someone responsible for the
product in Canada in the event of a reaction or if they have a
question or concern.
Standard Table Format for Non-Prescription
Drugs: The amendments include a requirement that outer
labels for non-prescription drug include a standard table format to
help consumers more readily locate important information. The
information in the table is required in both English and French and
must include adequate directions for use. The table is intended to
assist consumers in locating critical information about a product
and in making informed decisions at the point of selection and
Submission of Mock-ups of Labels and Packages:
The amendments require that a drug submission includes mock-ups of
labels and packages displaying an accurate representation of what
will be available on the market after the product is approved.
Significant changes to label and packaging following product
authorization which impact safety will require resubmission of the
Look-alike/sound-alike [LASA] Name Assessment:
Finally, the amendments codify the current Health Canada policy
that requires manufacturers to include in their drug submissions
evidence that the drug being submitted for approval would not be
confused with another drug because of a similar name. For drug
names, manufacturers will be need to submit an assessment that the
brand name of their drug would not likely be mistaken for the
brand, common or proper name of a different authorized drug.
The amendments to the Regulations will come into force in phases
in order to provide drug manufacturers with time to implement
necessary labelling and packaging changes, and to allow Health
Canada properly update its processes and publications.
Specifically, a one-year transition period will be granted for
prescription drugs and a three-year transition period will be
granted for non-prescription drugs.
For more information, the full text of the Regulations
amendments can be found here.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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