Guidance on new regulations for exceptional importation and sale of foreign-authorized drugs in Canada to mitigate drug shortages
Drug Establishment Licensing Bulletin 129, February 22, 2022
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As of March 2, 2022, new amendments to the Food and Drug Regulations (FDR) will take effect. The amendments create a framework for the exceptional importation and sale of foreign-authorized drugs in Canada to mitigate drug shortages. The provisions were first introduced through interim orders (IO) in 2020 and 2021.
Guidance related to the exceptional importation and sale framework is now available. We have included links to the guidance document and associated webpages.
In 2021, new regulatory provisions were put in place through Interim Order No. 2 respecting the importation and sale of medical devices for use in relation to COVID-19 (IO No. 2). These provisions allowed DEL holders to import and sell foreign-authorized drugs in order to alleviate or prevent shortages linked to the COVID-19 pandemic.
New regulations were published in Canada Gazette II on September 1, 2021. The regulations create a permanent pathway for the exceptional importation and sale of foreign-authorized drugs into Canada in response to a shortage. There is no longer a link to the COVID-19 pandemic in these regulations, which take effect on March 2, 2022.
A guidance document for these regulatory provisions is now available online:
The following resources related to this regulatory framework will continue to be maintained and updated by Health Canada:
Note: On March 2, please update your bookmarks to both of these webpages. The URLs will change and content will be updated to reflect the regulations taking effect. The current web addresses will automatically re-direct you to the new location.
What this means for DEL holders
Until March 2, 2022:
- IO No. 2 and its associated guidance remain in effect.
As of March 2, 2022:
- The new regulations take effect.
- The new guide (GUI-0148) will apply.
- All products on the List of drugs for exceptional importation and sale, including existing products, will now have an end of importation date and, if applicable, a maximum quantity that can be imported.
- Products imported into Canada before the end of importation date will be allowed to be sold in Canada until the product expires.
For questions about drug shortage and discontinuation regulations, email the Drug Shortages Division at Drug.shortages-Penurie.email@example.com.
To submit a proposal for adding a drug to the List of drugs for exceptional importation and sale or to notify us about upcoming importations, email
For questions on the DEL application requirements, email firstname.lastname@example.org.
Please ensure that all mention of the List of Tier 3 drug shortages, the List of Drugs for Exceptional Importation and Sale, and the proposal form contains the correct URL link for the new versions of these webpages and form.
Currently, the old links are inserted as placeholders because a decision has not been made yet (as of Jan 24, 2022) as to whether a new link is needed or if the old link will redirect to the new link.
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