In the October 2013 issue of RxAnalysis we reported on Health Canada’s proposed
amendments to the Canadian Food and Drug Regulations that were directed,
among other things, to the codification of a “look-alike sound-alike” policy
(click here to read this article). The objective of this policy is to avoid the confusion
(and safety concerns) that may arise between similar names of different drugs.
Patients, healthcare professionals and caregivers may confuse one drug name
for another which could result in the patient being dispensed or administered
the wrong drug. This policy will apply to all biologic and pharmaceutical drugs
(prescription and non-prescription) whether innovator or generic.
To accompany the changes to the Regulations, a revised Guidance Document
for Industry will also be released. The revised Guidance Document is intended
to standardize the information submitted by the drug submission sponsor and
generate consistency in the information received by Health Canada on the
likelihood of confusion between drugs with similar sounding and looking names.
The result of these changes will likely be an increase in the time (and cost) spent
by sponsors as they complete the requirements that will be imposed in the
assessment of the proposed name. The obligation to complete this assessment
will be on the sponsor. Sponsors will be required to submit a report on the
findings from a required series of tests to demonstrate that the proposed drug
name is not likely to cause confusion with other drugs or mislead as the drug’s
therapeutic effectiveness, composition or safety. Health Canada has the right to
accept or reject a name. A rejection could lead to a delay in the issuance of a DIN
While the consultation process was closed last fall, the expectation was that the
revised Guidance Document would have been finalized and released by now. We
understand that the revised Guidance Document is now expected to be released in
mid-2014. We will continue to keep you updated.
For a link to the proposed Guidance Document for Industry, please visit:
RxAnalysis is the Pharmaceutical and Healthcare Newsletter of Baker & McKenzie’s North American Intellectual Property Practice Group
is the Pharmaceutical and Healthcare Newsletter of Baker & McKenzie’s North American Intellectual Property Practice Group
Kamleh Nicola is a lawyer
practising in the Toronto
office of Baker & McKenzie in
pharmaceutical litigation and