Mandatory Reporting of Drug Shortages and Discontinuances

As of March 14 2017, regulatory amendments implementing certain drug supply reporting requirements have come into force in Canada.  Although industry had established its own voluntary reporting system and website for this purpose in 2012, the newly implemented regulatory changes make such reporting mandatory and establish a new website.   

Under the now-amended Food and Drug Regulations, drug manufacturers are required to report:

  • Anticipated drug shortages (defined as situations in which the manufacturer is unable to meet the demand for the drug)
  • Discontinuations of a drug; and
  • Any previously unreported shortages.

A new website has been launched by Health Canada to which manufacturers must post their reports:  Visitors to the website can view these reports and run searches.  Visitors can also set up email notifications for new or updated reports on shortages and discontinuations of specific companies, products or ingredients.   

It is important to note that the requirement to report drug shortages and discontinuations on the reporting website is independent of the duty to inform Health Canada when a drug manufacturer has not made a sale of a specific drug product on the Canadian market for 12 consecutive months.  

Health Canada’s Guidance for Manufacturers on the reporting requirements and associated timelines can be found here.