Designated Drugs on a DEL: What Importing a Foreign-Authorized Drug Actually Requires

When Health Canada adds a foreign-authorized drug to the List of Drugs for Exceptional Importation and Sale, the medicine does not import itself. A specific kind of company, a Drug Establishment Licence (DEL) holder, has to bring it into Canada, and it inherits a real set of licensing and quality duties the moment it does. Our companion guide explains how the exceptional importation pathway fills drug shortages. This article is the operational sequel: who actually gets to import a designated drug, what DEL scope they need, and what their quality system has to prove.

The stakes are practical. When Health Canada permitted South Korean-authorized BONKY Injection calcitriol into Canada on 24 August 2026, a Korean-labelled sterile injectable entered a Canadian supply chain. Someone had to hold the right licence, confirm the foreign site's manufacturing standards, receive and store the product correctly, communicate the product differences to prescribers, and be ready to recall it. That someone is the importer, and this is what the job involves.

Executive summary

• You need a Drug Establishment Licence with the correct activities to import and sell a designated drug. The exceptional importation pathway does not waive the licensing requirement.
• The importer keeps ownership of quality. You must show that the foreign fabricating, packaging, labelling and testing sites meet standards comparable to Canadian Good Manufacturing Practices.
• You must notify Health Canada's Drug Shortages Division of an upcoming importation, and stay within the end-of-importation date and any maximum quantity.
• A foreign-labelled product needs a documented gap assessment, a risk communication for health professionals, and controlled handling, storage and transport.
• Traceability and recall readiness are not optional. If the foreign product has to come back, you must be able to find every unit quickly.

Do you need a DEL to import a designated drug?

Yes. Importing a drug into Canada is a licensable activity under the Food and Drug Regulations, and that does not change because the product is a designated drug entering under the exceptional importation provisions. To import and sell a designated drug you must hold a Drug Establishment Licence that authorizes the import activity for the relevant dosage form and category, and where you also distribute or wholesale the product, your licence has to cover those activities too.

This is where timing bites. If your current licence does not list the activity, the dosage form or the category you need, you cannot simply start importing. You have to amend the licence first. Health Canada can expedite a licence issuance or amendment to help address a critical shortage, but you still have to ask, and you still have to support the request. Companies that treat their DEL renewals and amendments as a live, forward-looking process are far better placed to move when a shortage opportunity appears than those who discover a licensing gap on the day the drug is listed.

Which DEL activities you need

A DEL is not a single permission. It authorizes specific activities against specific dosage forms and categories. The table below maps common roles in an exceptional importation to the activity that role depends on. Confirm your own licence against the current Health Canada guidance, because the exact wording controls what you may lawfully do.

The point of the table is simple. Each thing you physically do to the product maps to an activity that has to be on your licence. If you plan to distribute as well as import, both activities must be listed. If you assume you can relabel a foreign product without checking, you may be acting outside your licence and outside the terms of the listing.

Notifying Health Canada before you import

Importing a designated drug is not a silent transaction. Health Canada expects importers to notify the Drug Shortages Division of an upcoming importation, so that the regulator can track what foreign-labelled product is entering the market and in what quantity. The Drug Establishment Licensing Bulletin that introduced the framework is clear that every listing carries an end-of-importation date, and often a maximum quantity, so the notification is also how you confirm your planned volume fits the terms of the listing.

Build this into your procedure. The notification is not a courtesy; it is part of using the pathway correctly, and it should be logged, dated and retained like any other regulatory communication.

GMP oversight: the importer still owns quality

A designated drug is manufactured to standards comparable to Canadian-authorized drugs, but comparable is not the same as verified, and it is the importer who has to do the verifying. Under Canadian Good Manufacturing Practices, an importer is responsible for confirming that the foreign buildings that fabricated, packaged, labelled and tested the product operate to acceptable standards. That responsibility does not disappear because a shortage created urgency.

In practice, the quality unit has to hold evidence of the foreign sites' GMP status, review the batch documentation that arrives with the product, and satisfy itself that the product was made, tested, stored and transported under proper conditions. Where your quality system requires a Quality Assurance Person to oversee or release product, that person needs the information to make an informed decision, not a rushed signature. Cold-chain or temperature-sensitive injectables such as calcitriol raise the bar further, because a break in storage or transport conditions can compromise a product that looked perfect on paper.

Managing the foreign label

The defining feature of a designated drug is that it wears a foreign label. That label may be in another language, may express strength or concentration differently, and may show a different presentation or different warnings from the Canadian product it is replacing. You cannot assume you are free to overlabel or repackage it. Whether any change to the label is allowed depends on the terms Health Canada sets for that specific listing, so confirm what is permitted before you touch the packaging.

What you can always do is manage the risk that the foreign label creates. A documented foreign-label gap assessment should compare the imported product against the Canadian product on name, active ingredient, strength, dose expression, presentation, storage conditions and warnings. Each difference then feeds a risk communication for prescribers and pharmacists, and a plan for clear French and English information at the point of care. This is the work that turns a foreign-labelled product into a safely usable Canadian supply.

Quality agreements and supplier qualification

You are taking product from a manufacturer you may never have worked with, in a market you do not normally source from, under time pressure. That is exactly the situation supplier qualification exists for. A written quality agreement should define who is responsible for what, how deviations and complaints are handled, and how information flows if a problem emerges. Our guide to building a supplier qualification programme that survives an inspection sets out the risk tiering and audit depth an inspector will expect to see, and the same discipline applies to a foreign supplier of a designated drug.

Recall readiness and traceability

Foreign-labelled product raises the odds of a recall, not because the drug is worse, but because a different label and a different presentation give more room for confusion. As the importer you must be able to trace where every unit went and pull it back quickly. That means accurate distribution records, a working recall procedure, and defined roles before anything goes wrong. A designated drug that cannot be traced is a designated drug that cannot be recalled, and that is a risk no quality unit should accept.

Inventory and the end-of-importation date

Every listing has an end date for importation, and sometimes a maximum quantity. Product imported before the end date may be sold until it expires, but you cannot keep importing once the date passes. This creates a genuine commercial risk: over-import, and you may be left holding foreign-labelled stock that Health Canada is not responsible for and that no longer has a Canadian shortage to serve. Forecast the shortage, match your volume to real demand, and track the end date as carefully as you track the licence.

Importer compliance checklist

Work through this list before you commit to importing a designated drug.

• Confirm the drug is on the current List of Drugs for Exceptional Importation and Sale, with its end-of-importation date and any maximum quantity.
• Check your Drug Establishment Licence lists the activities you will perform (import, and distribute or test where relevant) for the correct dosage form and category, and amend it before you act if it does not.
• Notify Health Canada's Drug Shortages Division of the upcoming importation, and keep the notification on file.
• Hold evidence that the foreign fabricating, packaging, labelling and testing sites meet standards comparable to Canadian GMP.
• Put a written quality agreement in place with the foreign supplier and qualify it against your supplier programme.
• Complete a foreign-label gap assessment and issue a risk communication covering every product difference, with French and English information for the point of care.
• Confirm your quality unit, and the QAP where required, can review batch documentation and release the product on evidence, not on urgency.
• Verify storage and transport conditions were maintained, especially for temperature-sensitive injectables.
• Keep distribution records and a tested recall procedure so any unit can be traced and retrieved quickly.

Common mistakes

• Assuming exceptional importation waives the licence. It does not. You still need a DEL with the right activities.
• Importing on the strength of a foreign approval without holding your own evidence that the foreign sites meet comparable GMP.
• Overlabelling or repackaging a foreign product without confirming it is permitted for that listing.
• Releasing product to meet a deadline before the quality unit has the batch documentation it needs.
• Over-importing, then holding unsellable foreign stock once the shortage ends or the end-of-importation date passes.

Frequently asked questions

Do I need a Drug Establishment Licence to import a designated drug?

Yes. Importing a drug into Canada is a licensable activity, and the exceptional importation provisions do not remove that requirement. You need a DEL that authorizes the import activity for the relevant dosage form and category, plus any other activity, such as distribution, that you will perform.

Which DEL activity does importing a designated drug depend on?

The import activity. If you also sell the product on to pharmacies, hospitals or other buyers, you rely on the distribute or wholesale activity as well. Testing and packaging or labelling are separate activities again, and each must appear on your licence if you perform it.

Can I relabel a foreign-authorized drug into English and French?

Not automatically. Whether any labelling change is allowed depends on the terms Health Canada sets for the specific listing. Do not assume you can overlabel or repackage. Confirm what is permitted first, and if relabelling is allowed, it becomes a package or label activity that your DEL must cover.

Does the importer have to confirm the foreign manufacturer meets GMP?

Yes. The importer is responsible for holding evidence that the foreign fabricating, packaging, labelling and testing sites operate to standards comparable to Canadian Good Manufacturing Practices. A shortage does not transfer that responsibility to anyone else.

What records should I keep for an imported designated drug?

Keep the importation notification, the foreign-site GMP evidence, the batch documentation, the quality agreement, the foreign-label gap assessment and risk communication, the storage and transport records, and full distribution records. Together these let you demonstrate control and run a recall if you have to.

What happens to unsold stock when the shortage ends?

Product imported before the end-of-importation date may be sold until it expires, but Health Canada is not responsible for designated drugs that remain unsold. That is why matching import volume to real demand is a commercial decision as much as a compliance one.

How MFLRC can help

Importing a designated drug is a licensing problem, a quality problem and a supply-chain problem at once. MF License and Regulatory Consultants helps importers handle all three. Our regulatory affairs, licensing and import/export team reviews your DEL scope, prepares amendments and drafts the importation notification. Our quality assurance and quality control specialists build the foreign-label gap assessment, quality agreement and batch-release process, and can provide QAP support. Through our audit services we assess foreign suppliers and pressure-test your recall readiness before an inspector does.

Planning to import a designated drug, or want your DEL and quality system ready before the next shortage? MFLRC gives importers a clear, defensible path through licensing, GMP oversight and foreign-label risk.

Conclusion

Exceptional importation gives importers a genuine chance to serve patients and win business during a shortage, but it hands them a full quality file to carry. The licence has to be right, the foreign site evidence has to be on hand, the label risk has to be managed, and the product has to be traceable. None of that is exotic; it is ordinary Good Manufacturing Practice applied to an unusual product, which is why an honest GMP inspection readiness self-assessment is the best preparation an importer can make before the next designated drug is listed.

Sources and references

• Health Canada, Guidance on Drug Establishment Licences (GUI-0002).
• 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, List of drugs for exceptional importation and sale.