Questions and Answers - Access to Drugs in Exceptional Circumstances

Urgent public health needs can occur, for example, during a flu pandemic, situations such as the opioid crisis or a military health emergency. Sometimes a drug that is needed for immediate use to respond to an exceptional public health crisis is not authorized for sale in Canada, but may be authorized for sale in another country. This guidance document provides an overview of the regulatory process under Division 10 of the FDR for the importation of drugs for an urgent public health need and outlines the roles and responsibilities of Health Canada, public health officials, DEL holders, and health care institutions.