Health Canada has announced its intention to require
prescription drug manufacturers to report drug shortages that
impact the Canadian market. Once in force, failure to report could
result in fines or other penalties (currently, notice of drug
shortages are posted by manufacturers on a voluntary basis on an
industry-run website).12 This February 10th
announcement clarifies Health Canada's intent to make reporting
of shortages mandatory and follows a recent consultation by Health
Canada on the current voluntary reporting system.
What you need to know:
Both the current voluntary reporting system and the proposed
mandatory reporting obligations apply to prescription drugs for
human use only, both branded and generic, and do not apply to
veterinary drugs, natural health products, or non-prescription
As an interim measure, Health Canada has launched two publicly
First, the Public Notification Register lists all drug
manufacturers who have made a commitment with Health Canada to make
timely public notifications of any actual and anticipated drug
shortages under the current voluntary reporting
Second, Health Canada will publish on a website letters issued
to drug manufacturers who have failed to provide timely public
notification of drug shortages.4
Currently published letters by Health Canada indicate that it
will not consider a report to be "timely" if notice of a
shortage is provided 2-3 weeks after a potential supply issue is
known to a manufacturer.
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