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:
- Significant shortage: At this time, Health Canada is basing eligibility on a drug being in a Tier 3 shortage , 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 and supports the safe use of the drug. Canadian importers must prepare and implement a risk communications plan to meet this requirement. The plan must indicate that the information is being provided in both official languages.
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.
- Notice for industry: Ensuring predictability for interim orders relating to COVID-19
- Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (September 2020)
- Interim Order respecting the prevention and alleviation of shortages of drugs in relation to COVID-19 (October 2020)
- Interim order respecting drug shortages (safeguarding the drug supply) (November 2020)
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