How Named-Patient and Foreign-Pack Drug Supply Works in Canada
When a medicine a patient needs is not marketed in Canada, or is in shortage, there are lawful routes to bring it in. This guide explains the Special Access Programme, exceptional importation during shortages, and what a licensed wholesaler does at each step.
Who this is for
Hospital and community pharmacists, clinical trial supply managers, and procurement teams who need a medicine that is either not marketed in Canada or is not currently available from the Canadian supply chain.
The two lawful routes
1. Health Canada's Special Access Programme (SAP). SAP allows a practitioner to request access to a drug that is not authorized for sale in Canada, for a patient with a serious or life-threatening condition when conventional therapies have failed, are unsuitable, or are unavailable. The practitioner — not the wholesaler — submits the request to Health Canada. If it is authorized, the drug can be imported and sold to that practitioner for that patient. Health Canada also publishes a list of drugs most often requested through SAP, which is a useful early signal of where Canadian demand exceeds Canadian supply.
2. Exceptional importation and sale during shortages. When Health Canada determines that a shortage of a marketed drug is serious enough (typically a Tier 3 shortage), it can add foreign-authorized versions of that drug to its List of Drugs for Exceptional Importation and Sale. Products on that list — often called "foreign packs" because they carry another country's labelling — can be imported and sold in Canada for the duration of the shortage, subject to the conditions Health Canada attaches (labelling, patient information, reporting).
What "named patient" means in practice
Outside Canada, "named-patient supply" is the general term for supplying an unlicensed medicine to a specific patient on a clinician's request. In Canada the equivalent mechanism is SAP. The practical work is the same: identify a foreign-authorized product that is therapeutically equivalent, confirm it comes from a regulated market with GMP manufacturing, secure the supply with full documentation, and move it under controlled conditions.
What the licensed wholesaler does
A Canadian company that imports and distributes drugs must hold a Drug Establishment Licence (DEL) from Health Canada covering those activities, and must store and handle product under Good Manufacturing Practices for distribution. In a named-patient or exceptional-import supply, the wholesaler:
- Confirms the foreign product's regulatory status in its country of origin (for example an EU marketing authorization, FDA approval, or MHRA licence) and the manufacturer's GMP standing.
- Sources from a licensed supplier in that market and obtains the Certificate of Analysis, batch and expiry details, and chain-of-custody records.
- Handles customs and import documentation, including acting as importer of record where required.
- Maintains temperature control end-to-end and provides the temperature log with the shipment.
- Delivers to the authorized recipient with the documentation Health Canada's authorization or listing requires.
What to have ready before you ask for a quote
Product name and strength, dosage form, quantity and urgency, the patient-level or trial-level authorization (SAP letter or the shortage listing you are relying on), and any labelling or language requirements for the receiving site. With those in hand, a supplier can usually confirm availability and lead time within one business day.
A note on what this guide is not
This is a description of how the process works, not regulatory or medical advice. Eligibility for SAP, and whether a product is on the exceptional importation list, are decisions Health Canada makes.
Nexara Health is a Health Canada-licensed pharmaceutical wholesaler (DEL 3-002896-A). Last reviewed September 2026.