Exceptional importation and sale of drugs in relation to COVID-19: Overview

There is an unprecedented demand and urgent need for access to drugs during the COVID-19 pandemic. On March 30, 2020, the Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. The interim order (IO) allows certain drugs that may not fully meet regulatory requirements to be imported and sold in Canada.

An IO is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory processes. Further information on this Interim Order can be found in the Explanatory Note. 

Drugs that are eligible under the interim order

Drugs included on the List of Drugs for Exceptional Importation and Sale are called “designated drugs” and are eligible for the exceptional importation and sale provisions provided for in the Interim Order. The list, which will be updated as required, is incorporated by reference in the IO and is maintained by Health Canada.

Criteria for adding a drug to the List of Drugs for Exceptional Importation and Sale

At this time, drugs that meet both of the following criteria will be considered for addition to the list of designated drugs:

• Significant shortage: Only drugs in shortage designated as a Tier 3 shortage are eligible, as defined by the Multi-Stakeholder Steering Committee Protocol on Notification of Drug Shortages.
• Good manufacturing practices compliance: Drugs must be manufactured in accordance with GMP requirements. Companies that are importing and selling the designated drugs must have a Drug Establishment Licence (DEL):
  • The DEL must cover the importation of the drug under the applicable category and dosage form.
  • Buildings outside Canada must be listed in the Foreign Annex of the importer’s DEL for the applicable activity, category of drugs and dosage.
• Accessibility of Information to Support Safe Use: Canadian importers must take steps to ensure that information is accessible to Canadians that supports the safe use of the drug. Canadian importers are expected to prepare and implement a risk communications plan to meet this requirement, which would include taking steps to ensure information is accessible in both official languages.

NOTE: Other criteria may also be considered by Health Canada in adding products to the list of designated drugs.

Visit the drug shortages website and sign up for daily notifications of drug shortages.

Related links

• Notice for industry: Ensuring predictability for interim orders relating to COVID-19