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

The COVID-19 pandemic has created unprecedented supply and demand challenges for certain drugs. 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 (archived copy). To meet this need, the interim order (IO) allowed certain drugs that may not fully meet regulatory requirements to be imported and sold in Canada. Since the IO would have expired after 1 year in force, on March 1, 2021, the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. IO No. 2 extends and modifies certain measures for drugs that were in the first interim order.

Please consult the explanatory note for further information on IO No. 2, including the differences between the 2 interim orders. The landing page  for this IO provides links to further information about drugs and the other products regulated under the IO.

An IO is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory processes.

Drugs that are eligible under the interim order

To be eligible for the exceptional importation and sale provisions in IO No. 2, drugs must be included on the list of drugs for exceptional importation and sale. Drugs on this list are called “designated drugs.” The list of designated drugs from the first IO has been automatically carried over to IO No. 2 and continues to operate as before. Health Canada maintains and updates the list as required.

Criteria for adding a drug to the list of drugs for exceptional importation and sale

Drugs that meet the following criteria will be considered for addition to the list of designated drugs:

Note: Other criteria may also be considered by Health Canada in adding products to the list of designated drugs on a case-by-case basis.

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

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