Named Patient Supply in Canada

Licensed import and delivery of unapproved medicines for individual Canadian patients under Health Canada's Special Access Programme

Named patient supply is how a Canadian physician obtains a medicine that is not authorized for sale in Canada for one identified patient. Health Canada's Special Access Programme (SAP) issues the authorization to the practitioner; a licensed establishment then imports the product, stores it under the correct conditions, and delivers it to the hospital pharmacy, clinic, or dispensing pharmacy named on the authorization. Nexara Health performs that second half of the process under Drug Establishment Licence #3-002896, from our Winnipeg facility at 9 South Landing Dr #116, Winnipeg, MB R4G 0C4, Canada.

We work on a per-patient basis. Each request is treated as its own file: product identification down to the exact presentation and strength, confirmation that the manufacturer or its authorized distributor in the source country will release stock against a Canadian SAP letter, a landed-cost quote that separates product, freight, customs, and handling, and a documented delivery to the named site. Nothing is pooled, substituted, or drop-shipped through an unverified broker.

Most named-patient enquiries are quoted within 24 hours of receiving the drug name, strength, presentation, quantity, and the SAP authorization or its reference number. Where the authorization is still pending, we can quote provisionally so that clinical teams and payers know the cost before the letter arrives.

What is included

• Health Canada DEL #3-002896 — import, wholesale, and storage authorizations
• Import against Special Access Programme letters of authorization
• Single-patient, hospital-pharmacy, and clinic delivery
• Orphan, discontinued, and never-marketed-in-Canada products
• GDP cold chain at 2–8 °C, −20 °C and −80 °C with continuous monitoring
• Certificate of Analysis, batch and expiry records, chain-of-custody file
• Landed-cost quotes that separate product, freight, duty, and handling
• Repeat-supply scheduling for chronic named-patient treatment

How a named patient request runs end to end

Step one is identification. A drug name alone is rarely enough: two products sharing a brand name can differ by salt, strength, device, or presentation between markets, and the wrong presentation is a rejected shipment. We confirm the exact source-market product, its marketing authorization holder, the pack configuration, and the shelf life we can realistically expect on arrival.

Step two is the authorization. The treating practitioner submits the SAP request to Health Canada, stating the patient, the diagnosis, why authorized Canadian therapies are unsuitable, and the quantity required. Health Canada responds to the practitioner. Nexara does not submit on the prescriber's behalf, but we supply the product and supplier details the request needs, and we flag in advance where a source country will not release stock for export.

Step three is procurement and import. Once the letter of authorization exists, we place the order with the manufacturer or its authorized distributor, arrange export clearance in the source market, and import into Canada under our DEL. Cold-chain products ship in qualified shippers with data loggers; the temperature record travels with the file.

Step four is delivery and record keeping. Product is delivered to the site named on the authorization. The file we hand over contains the invoice, the Certificate of Analysis where the manufacturer provides one, lot number and expiry, the import documentation, and the temperature record. That file is what an inspector, a hospital pharmacy director, or a payer will ask for later.

What we source, and where from

Typical named-patient requests fall into four groups: medicines approved elsewhere but never filed in Canada, medicines discontinued by their Canadian marketing authorization holder, orphan products with no Canadian distribution, and products in Canadian shortage where an equivalent foreign presentation can bridge the gap. We also handle continuation of therapy for patients who began treatment abroad and have moved to Canada.

Our regular source markets are the United States, the United Kingdom, Germany, France, Italy, Spain, the Netherlands, Switzerland, Australia, and Japan, with authorized-generic sourcing from India where the manufacturer holds a recognized approval and will provide full release documentation. Country choice is driven by three things: whether the exact presentation exists there, whether export from that market is permitted for the quantity requested, and total landed cost including freight and cold chain.

We do not buy from parallel-trade grey markets or unverified online sellers. Every unit we import comes from the manufacturer, the marketing authorization holder, or a distributor authorized by them, and we keep the paperwork that proves it.

Timelines, cost, and what changes them

After the SAP authorization is in hand, a straightforward European or United States sourced product usually lands in one to three weeks. Markets requiring export permits, restricted or controlled products, and products manufactured to order run four to eight weeks. Urgent compassionate cases can sometimes be compressed to five to ten business days when the manufacturer holds stock and freight capacity is available; we will say plainly at quote time whether that is realistic.

Named-patient pricing is not list pricing. Small-batch procurement, single-pack freight, qualified cold-chain packaging, customs brokerage, and per-file documentation all carry real cost, and we itemize them rather than burying them in a unit price. Where a treatment will repeat monthly, we schedule and consolidate shipments to bring the per-cycle cost down.

Reimbursement varies by province and product. Several provincial programs review SAP products case by case, and private insurers, manufacturer patient-support programs, and hospital drug budgets may each carry part of the cost. We supply the itemized quote and documentation those reviews require; we do not advise on coverage.

Compliance boundaries we hold

Named patient supply is a regulated activity with hard edges. We supply only against a valid Health Canada authorization and only to the site named on it. We do not supply patients directly, we do not hold unapproved product as speculative stock, and we do not repackage or relabel unapproved product. Controlled substances under the CDSA are handled only where the specific authorization is in place for that schedule.

Every shipment is traceable one step up and one step down: which manufacturer lot arrived, which authorization it was released against, and which site received it. That record is retained for the period required of a licensed wholesaler and is available for Health Canada inspection.

These controls support the regulatory work your institution is doing. They are not a substitute for it, and nothing on this page is medical, legal, or reimbursement advice.

Frequently asked questions

What is named patient supply?

Named patient supply is the import and delivery of a medicine that is not authorized for sale in Canada, for one identified patient, under an authorization issued by Health Canada to that patient's practitioner. The product is supplied to the practitioner or the pharmacy named on the authorization, never to the patient directly by the wholesaler.

Who can request a named patient medicine in Canada?

Only a licensed Canadian practitioner — a physician, nurse practitioner, or dentist within their scope — may submit a Special Access Programme request. Patients and caregivers cannot apply themselves. Nexara becomes involved once the practitioner has the authorization or has started the request.

Is Nexara licensed to import unapproved medicines into Canada?

Yes. Nexara Health holds Health Canada Drug Establishment Licence #3-002896 with import, wholesale, and storage authorizations, operating from Winnipeg, Manitoba. Controlled substances scheduled under the CDSA require separate authorization and are handled only where that authorization exists.

How long does a named patient order take?

Typically one to three weeks after the authorization is issued for products sourced in Europe or the United States, and four to eight weeks where export permits, restricted markets, or made-to-order manufacture are involved. Urgent compassionate cases can sometimes be expedited to five to ten business days.

How is a named patient supply quote priced?

We quote landed cost with the components separated: product cost from the source market, freight, cold-chain packaging where required, customs and brokerage, and handling. Small-batch and single-pack sourcing is more expensive per unit than commercial supply, so we show the arithmetic rather than a blended number.

What documentation comes with the shipment?

The invoice, lot number and expiry date, the Certificate of Analysis where the manufacturer issues one for the batch, import documentation, the delivery record for the named site, and the temperature record for cold-chain products.

Can Nexara supply repeat named patient treatment?

Yes. For chronic therapy we schedule recurring shipments against the current authorization, track expiry dating so that stock is usable on arrival, and consolidate freight where the dosing schedule allows.

Related pages

• Comparator Sourcing Canada
• Named Patient Program Canada
• Special Access Programme guide
• Rare Disease Sourcing
• Canadian Drug Shortage Tracker
• Pharmaceutical Wholesaler Canada