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.
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.
- 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.
- A Questions and Answers document provides an overview of the regulatory process, information on how to comply with the Regulations, as well as a description of roles and responsibilities.
- Part C, Division 10 of the Food and Drug Regulations, entitled “Access to Drugs in Exceptional Circumstances”. Health Canada published these Regulations in the Canada Gazette, Part II on July 12, 2017.
- Making Urgently Needed Drugs Available: Infographic
- The Sale of Drugs for Public or Canadian Armed Forces Health Emergencies (referred to as 'block release' regulations) – The Special Access Program (SAP) administers the block release regulations in Division 11 of the FDR. These regulations give the Minister of Health the authority to consider applications from public health officials (PHOs) to purchase drugs that are not authorized for sale in Canada, for immediate use in a public or military health emergency, and/or for stockpiling in anticipation of such an emergency. PHOs interested in requesting drugs through the block release regulations should contact the SAP.
- The Notice of Compliance (NOC) Database and the Drug Product Database (DPD) can be used to search which drugs in Canada have been issued a NOC, as well as the current status of a drug in Canada, respectively.
- The Patent Register is an alphabetical listing of medicinal ingredients and their associated patents, the patent expiry dates and other related information.
- Adverse reactions can be reported to the Canada Vigilance Program of the Marketed Health Products Directorate of Health Canada.
For More Information
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