Access to Drugs in Exceptional Circumstances

The Regulatory Pathway

The Access to Drugs in Exceptional Circumstances regulatory pathway enables access to drugs which have been authorized for sale in certain foreign jurisdictions, but are not available in Canada, to address urgent public health needs. This pathway is intended for public health events that are exceptional in nature and that are occurring (or imminent) and require immediate action.

Several conditions must be met in order for a drug to become eligible for importation and sale under this scheme. In particular, a public health official must have notified the Minister of an urgent public health need for the immediate use of the drug, as well as the intended use or purpose of the drug within their respective jurisdiction. An eligible drug is only allowed for sale in the notifying jurisdiction.

The List

Details of drugs eligible for importation and sale under this regulatory pathway appear on the List of Drugs for an Urgent Public Health Need (the List). Additional information obtained from the notification made by the public health official can also be found on the List. The List is incorporated by reference into the Food and Drug Regulations and is maintained by the Minister.

Updates to the List are published on the same day. If you are interested in being kept informed of updates to the List, please subscribe to the Drug Products RSS feed.

Notification Forms

  • The Notification of Urgent Public Health Need Form must be used by public health officials to notify the Minister of an urgent public health need for the immediate use of the drug and the intended use or purpose of the drug within their respective jurisdiction. This form can also be used to withdraw a previous notification.
  • The Notification of Importation Form must be used by importers to notify the Minister within 15 days after the importation of the drug into Canada.

Related Resources

For More Information

Please contact:
Email: drugs_urgent_need_besoin_urgent_medicaments@hc-sc.gc.ca

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