Foreign Labels, Canadian Shelves: How Health Canada's Exceptional Importation Pathway Fills Drug Shortages

When a Canadian-authorized medicine runs out and no domestic supply can be found in time, Health Canada has a rarely explained tool for keeping patients treated. It can allow a version of the drug that was approved in another country, still carrying that country's labelling, to be imported and sold here for a limited period. On 24 August 2026, Health Canada used exactly this tool. It permitted the exceptional importation and sale of South Korean-authorized BONKY Injection, 1 mcg per mL calcitriol, to mitigate a shortage of Canadian-authorized Calcitriol Injection USP, 1 mcg per mL. The ampoules reaching Canadian shelves are labelled in Korean, because they were never intended for the Canadian market.

This is the exceptional importation and sale pathway, and it is one of the least understood corners of Canadian drug regulation. For importers, distributors and market authorization holders, it opens a real commercial and compliance opportunity, but only when the establishment licensing, quality oversight and labelling risk are managed correctly. This guide explains what the pathway is, how a drug becomes a designated drug, how it differs from the Foreign Reliance Order, and what your business must do to use it responsibly.

Executive summary

• Exceptional importation and sale is a permanent Food and Drug Regulations framework, in force since 2 March 2022, that lets a Drug Establishment Licence (DEL) holder import and sell a foreign-authorized drug to relieve a shortage in Canada.
• A drug becomes eligible only after Health Canada adds it to the List of Drugs for Exceptional Importation and Sale. Drugs on that list are called designated drugs, and the list is incorporated by reference into the regulations.
• A designated drug carries foreign-market labelling, does not receive a Canadian Notice of Compliance, and can be imported only until a set end-of-importation date, sometimes with a maximum quantity.
• Only drugs in, or at risk of, a Tier 3 shortage (the shortages with the greatest impact on the Canadian health system) are normally eligible.
• The pathway is not the Foreign Reliance Order. Reliance is a market authorization route; exceptional importation is a temporary shortage-mitigation route for foreign-labelled product.
• The BONKY calcitriol addition on 24 August 2026 is a current, real example of the pathway in action for a sterile injectable.

What is exceptional importation and sale?

Exceptional importation and sale is a Health Canada pathway that allows a foreign-authorized drug to be imported into Canada and sold to relieve or prevent a drug shortage, even though the product is labelled for a foreign market and has not been authorized for sale in Canada in the normal way. It is set out in sections C.10.004 to C.10.013 of the Food and Drug Regulations, and it has been a permanent part of Canadian law since 2 March 2022.

The framework did not appear overnight. Its provisions were first introduced through interim orders in 2020 and 2021, when the COVID-19 pandemic strained global drug supply. Health Canada then published the permanent regulations in the Canada Gazette, Part II on 1 September 2021, and they took effect on 2 March 2022 with no remaining link to COVID-19. The detailed expectations for how to use the pathway now live in Health Canada's Guide GUI-0148, the guide to the exceptional importation and sale of drugs in response to drug shortages.

It helps to see where this fits. Canadian shortage rules already require market authorization holders to report and manage shortages, as we cover in our guide to Canada's drug shortage regulations and what market authorization holders must do. Reporting is about visibility. Exceptional importation is one of the actual supply tools Health Canada can reach for when reporting shows that a critical shortage cannot be solved from Canadian-authorized product alone.

What is a designated drug?

A designated drug is a foreign-authorized drug that Health Canada has added to the List of Drugs for Exceptional Importation and Sale. Only a drug on that list may be imported and sold under the exceptional importation provisions. The list is incorporated by reference into the Food and Drug Regulations, which means the list itself has legal force and Health Canada can update it as shortages change.

A designated drug has a distinct regulatory character. It carries foreign-market labelling, which is not necessarily bilingual English and French. It is manufactured to standards comparable to Canadian-authorized drugs, but it may not fully meet every Canadian regulatory requirement. It does not receive a Canadian Notice of Compliance. Each entry on the list has an end-of-importation date, and often a maximum quantity that may be imported. Product brought into Canada before that end date may be sold until it expires. Health Canada can remove a designated drug from the list, for example when the foreign authorization is no longer valid, when the product is recalled, or when the Canadian shortage has resolved.

The BONKY calcitriol case: a real 2026 example

On 24 August 2026, Health Canada issued a health professional risk communication on the importation of South Korean-authorized BONKY Injection, 1 mcg per mL calcitriol, to mitigate the shortage of Canadian-authorized Calcitriol Injection USP, 1 mcg per mL. BONKY is indicated for the management of hypocalcemia in patients undergoing chronic renal dialysis, so the shortage touches a vulnerable dialysis population who cannot simply switch to another therapy.

Health Canada was explicit that there are differences between the South Korean-authorized and Canadian-authorized products, and that health professionals must be aware of them. That single sentence captures the whole compliance burden of the pathway. The medicine gets to the patient, but the importer, the pharmacy and the prescriber now share responsibility for bridging a foreign label to safe Canadian use. For a sterile injectable dosed by concentration, a misread strength is not a theoretical risk.

Exceptional importation vs Foreign Reliance Order vs standard authorization

Readers routinely confuse the three ways a drug can reach the Canadian market. They solve different problems. The table below sets them side by side.

The key distinction is permanence. The Foreign Reliance Order gives a product a genuine Canadian market authorization on the strength of another regulator's review. Exceptional importation gives no such authorization; it is a temporary bridge for foreign-labelled stock while a shortage is active. If you operate internationally, it is worth comparing this with how the European Union approaches supply security through EMA shortage prevention plans under Article 117.

Which drugs qualify: Tier 3 shortages

Only drugs that are in, or at risk of, a Tier 3 shortage are normally eligible for exceptional importation. Tier 3 shortages are those with the greatest potential impact on Canada's drug supply and health care system. Medical necessity and the low availability of alternative supplies, ingredients or therapies decide how serious the impact is.

A Tier Assignment Committee, made up of federal, provincial and territorial governments, health care professionals and industry stakeholders, recommends the tier of an actual or anticipated shortage. It reviews the information gathered, discusses the potential impact, and considers the steps needed to mitigate it. Only after a shortage reaches the Tier 3 threshold, and no adequate Canadian-authorized supply exists, does exceptional importation come onto the table.

How the pathway works, step by step

The mechanics are straightforward once the roles are clear. In practice the process moves through the following stages.

• Identify the shortage. Health Canada, or a stakeholder through a proposal, identifies a Tier 3 shortage that cannot be met with Canadian-authorized product.
• Propose a foreign product. A suitable foreign-authorized product, manufactured to comparable standards, is proposed for the List. Health Canada assesses each case on its own facts.
• Add to the List. Health Canada adds the drug to the List of Drugs for Exceptional Importation and Sale, with an end-of-importation date and, where set, a maximum quantity.
• Notify and import. A DEL holder notifies Health Canada's Drug Shortages Division of the upcoming importation and imports the designated drug under its establishment authorizations.
• Manage the foreign label. The importer and sellers manage the differences between the foreign label and Canadian expectations, and communicate them to prescribers and pharmacists.
• Sell down and stop. Product imported before the end date may be sold until it expires. Health Canada removes the drug from the List when the shortage resolves.

The heaviest lifting sits with the DEL holder, whose establishment licence must cover the activities being performed. Where a licence needs to be issued or amended quickly to support a critical shortage, the process can be expedited, which is one reason importers benefit from planning their licence renewals and amendments before a shortage forces the pace.

Compliance checklist

Before importing or selling any designated drug, confirm each of the following.

• The drug is on the current List of Drugs for Exceptional Importation and Sale, and you have checked it today, not last month.
• You hold the correct Drug Establishment Licence for the activities you will perform, including import and, where applicable, distribution and wholesale.
• You have notified Health Canada's Drug Shortages Division of the upcoming importation.
• You have confirmed the end-of-importation date and any maximum quantity, and planned volumes so you do not over-import.
• You have completed a foreign-label gap assessment covering name, strength, dose expression, presentation and warnings against the Canadian product.
• You have a risk communication ready for health professionals that spells out every product difference, and a plan for French and English communication at the point of care where the label is not bilingual.
• You maintain GMP oversight and records showing the product was handled, stored and transported under proper conditions, and can be traced and recalled quickly.

Common mistakes

• Treating the pathway as a market authorization. A designated drug has no Canadian Notice of Compliance and can be sold only for a limited period.
• Importing before the drug is on the List, or after the end-of-importation date has passed.
• Assuming the foreign label is close enough. Dose-expression and presentation differences have caused real medication errors.
• Forgetting the establishment licence. The activities still need the right DEL scope, even in a hurry.
• Over-importing, then being left with unsold foreign-labelled stock that Health Canada is not responsible for.

Frequently asked questions

What is a designated drug in Canada?

A designated drug is a foreign-authorized drug that Health Canada has placed on the List of Drugs for Exceptional Importation and Sale. Being on that list is what makes the drug eligible to be imported and sold in Canada under the exceptional importation provisions, even though it carries foreign-market labelling and has no Canadian market authorization.

Can Health Canada allow foreign-labelled drugs to be sold in Canada?

Yes. Under sections C.10.004 to C.10.013 of the Food and Drug Regulations, Health Canada can permit a foreign-authorized drug that is labelled for another market to be imported and sold in Canada to relieve a shortage. The product must be manufactured to comparable standards, and it is only allowed for a limited period.

Do exceptional-importation drugs have a Canadian DIN or Notice of Compliance?

No. A designated drug is not authorized through the normal Canadian route, so it does not receive a Canadian Notice of Compliance. It is permitted to be sold because it is on the List of Drugs for Exceptional Importation and Sale, not because it holds a Canadian market authorization.

Who can import a drug on the exceptional importation list?

A Drug Establishment Licence holder whose licence covers the relevant activities, such as importing and distributing, may import a designated drug. The DEL holder must notify Health Canada's Drug Shortages Division of the upcoming importation and manage the product under proper GMP oversight.

How is exceptional importation different from the Foreign Reliance Order?

The Foreign Reliance Order is a market authorization pathway; it gives the product a Canadian authorization on the strength of another regulator's review, with Canadian labelling. Exceptional importation is a temporary shortage-mitigation pathway for foreign-labelled product that never receives a Canadian authorization. One is about approving a drug; the other is about bridging a supply gap.

How long can a designated drug be sold?

Each designated drug has an end-of-importation date. Product imported before that date may be sold until it expires. Once the shortage resolves, Health Canada removes the drug from the list, and no further importation is allowed.

How MFLRC can help

The exceptional importation pathway rewards preparation and punishes improvisation. MF License and Regulatory Consultants helps importers and market authorization holders use it correctly. Our regulatory affairs, licensing and import/export team advises on the pathway itself, supports Drug Establishment Licence applications and amendments, and prepares the importation notifications Health Canada expects. Our quality assurance specialists build the foreign-label gap assessment, the GMP oversight and the recall readiness that a designated drug demands, all part of our broader pharmaceutical regulatory support. We also help market authorization holders build a shortage-mitigation strategy so that a Tier 3 shortage does not become a scramble.

Importing a designated drug to cover a shortage, or want to be ready before the next one? MFLRC helps importers and market authorization holders navigate the exceptional importation pathway, DEL obligations and foreign-label risk with confidence.

Conclusion

Exceptional importation and sale is a quiet but powerful part of Canada's shortage toolkit. It lets a foreign-authorized medicine reach a Canadian patient when nothing else can, but it does so by putting a foreign-labelled product into a Canadian supply chain, which shifts real responsibility onto the importer, the seller and the health professional. The BONKY calcitriol addition on 24 August 2026 shows the pathway working exactly as intended, and it shows why the label, the licence and the communication all have to be right. Understood and used well, exceptional importation protects patients. Used carelessly, it creates the very safety risk it is meant to solve.

Sources and references

• Health Canada, List of drugs for exceptional importation and sale.
• Health Canada, Guide to the exceptional importation and sale of drugs in response to drug shortages (GUI-0148).
• Health Canada, Drug Establishment Licensing Bulletin 129: guidance on the exceptional importation and sale of foreign-authorized drugs.
• Health Canada, Tier 3 drug shortages.
• Health Canada, Importation of South Korean-Authorized BONKY Injection, 1 mcg/mL Calcitriol (24 August 2026).