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Federal Rules – Mandatory Reporting Of Drug Shortages

Ottawa/Chilliwack/Abbotsford – The Honourable Minister of Health, Rona Ambrose, announced that the Government is taking the next step towards implementing mandatory reporting of drug shortages by companies. The amendments being proposed to the Food and Drugs Regulations would require manufacturers to:

  • provide six-months advance notice of anticipated shortages or discontinuations on a public website, and if the situation is unanticipated, within two days of knowing of a shortage or deciding to discontinue a drug; and
  • provide information about the implicated drug

Earlier, more comprehensive and reliable information on drug supply disruptions will give healthcare providers more time and confidence to make alternate treatment plans. Proposed new regulations were posted for consultation in the Canada Gazette on June 20 for a 75-day comment period.

Health Canada will also soon issue a request for proposals for a third party to create and administer the new independent reporting website.

Quick Facts

  • This announcement followed extensive consultations with Canadians, medical professionals, and other key stakeholders in which there was strong support for mandatory shortage reporting on a non-industry system to ensure Canadians have access timely, reliable and comprehensive drug shortage information.
  • The new third-party website, independent from manufacturers, will be established to provide timely, comprehensive and reliable information to Canadians on anticipated and actual drug shortages and discontinuations.
  • Canadians will be able to find important information on shortages and discontinuations, as well as details on the actions taken from various players across the supply chain to address shortages and discontinuations,
  • While the regulations are being finalized and the public website created, manufacturers are expected to continue voluntarily posting information on all shortages and discontinuances on the industry-run website,
  • is an industry-funded, industry-led website launched in March 2012 in response to calls from the then Minister of Health, for manufacturers to make essential information about drug shortages readily available to Canadians and the health care system.
  • To reflect and encourage industry accountability, a Public Notification Register has been launched on Health Canada’s website that lists all the manufacturers that have committed to voluntarily post their shortages, as well as letters to manufacturers that fail to publicly notify.

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