Health Canada introduced the regulatory amendments in July 2014
as part of its Regulatory Transparency and Openness Framework
and its commitment to make information more readily available to
Canadians. The Regulations Amending the Food and Drug
Regulations (Labelling, Packaging and Brand Names of Drugs for
Human Use) – more commonly known as the "Plain
Language Labelling amendments" – came into force on June
13, 2015. The provisions now in force apply to prescription drug
products and those that are obtained through a healthcare
professional. The plain language requirements for non-prescription
products will come into force in 2017.
The Plain Language Labelling amendments aim to improve the safe
use of drugs and help reduce preventable harms from medication
errors by making drug labels and safety information easier to read
5 Requirements for Plain Language Labelling
The Plain Language Labelling amendments include five
core requirements that prescription drug manufacturers
must comply with during the pre-market submission period. The five
requirements are as follows:
Compliance with plain language labelling provisions that
explicitly link the readability of the product label to the factors
such as clear writing, color contrast, font size and
Submission of a full mock-up of the product label and packaging
intended to be used for the sale of the product. The submission
allows Health Canada to review an accurate representation of what
the product will look like when it becomes available in the
Canadian market in advance of approval.2
The requirement to include the contact information of someone
who is responsible for the product in Canada should a patient
experience a problem, or have a question or concern about the drug
Submission of a Look-alike Sound-alike (also referred to as
"LASA") assessment of the proposed product
name.4 Similarities between product names can cause
health care professionals and patients to confuse one product for
another, and can result in prescribing errors, transcription
errors, dispensing errors and/or patient self-selection errors. The
mandatory LASA assessment helps to ensure that the drug brand name
will not be confused with another drug's brand, common or
proper name due to similar sounding or looking names.
For non-prescription products, the inclusion of a standard drug
information table which must contain information such as
indications or uses, recommended doses, route of administration,
storage conditions, a list of medicinal and non-medicinal
ingredients, and contact information to allow patients to report
In order to provide support and direction to manufacturers on
how to comply with the plain language labelling requirements,
Health Canada has created various policies and guidance documents,
including the "Guidance Document for Industry – Review of
Drug Brand Names", which came into effect the same day as
the amendments, and the "Good Label and Package Practices Guide"
which is currently in draft form. Health Canada will likely provide
for further guidance to help manufacturers design safe and clear
labels to establish consistent practices across the industry.
1. See section A.01.017 of the Food and Drug
Regulations, C.R.C., c. 870 ("FDR")
2. See FDR sections C.01.014.1(2)(m.1) and C.08.002(2)(j.1).
3. See FDR section C.01.004.01(1).
4. See FDR sections C.01.014.1(2)(o) and C.08.002(2)(o).
5. See FDR section C.01.004.02(1).
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