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).1 2 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 drugs.
- As an interim measure, Health Canada has launched two publicly available resources.
- 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 system.3
- 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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