Health Canada Special Access Programme: How a Clinician Requests a Drug Not Marketed in Canada
A practical guide for Canadian clinicians and hospital pharmacists to the Special Access Programme: when it applies, how to file, what the supplier needs, and what happens after supply.
When SAP applies
The Special Access Programme (SAP) lets a practitioner request 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 unavailable [1]. SAP is not a route around a marketed Canadian product; if a DIN is marketed and merely short, the shortage routes apply first [2].
The request
1. Confirm the drug has no marketed Canadian DIN in the Drug Product Database, or that the Canadian DIN is dormant/cancelled [3].
2. Complete the SAP request form (Form A for a new request) with patient details, diagnosis, rationale, and the name of the manufacturer or supplier who will provide the drug [1].
3. Submit to Health Canada's SAP; urgent requests are handled on an expedited basis [1].
4. On authorization, the named supplier ships the drug to the practitioner. The supplier must be able to lawfully export from its market and, if importing into Canada as a business, hold a DEL covering import [4].
What the supplier needs from you
The SAP letter of authorization (number and quantity), the delivery address of the institution, and the practitioner's contact. From the supplier you should receive the source-market registration details, Certificate of Analysis, batch and expiry, and for cold-chain products the temperature record.
After supply
The practitioner must report on the use of the drug to Health Canada as required under the authorization, including any adverse reactions [1].
How Nexara Health helps
For any Canadian DIN, our page lists the same-molecule registrations abroad, so the SAP form can name a specific supplier and market from the start. Nexara Health (DEL #3-002896) imports and delivers SAP product with the documentation above. [Request a quote](/contact) or read [how named-patient and foreign-pack supply works](/resources/named-patient-foreign-pack-supply-canada).
Sources
[1] Health Canada, Special Access Program for drugs: overview, forms and guidance — https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs.html
[2] Health Canada, Drug shortages in Canada — https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-shortages.html
[3] Health Canada, Drug Product Database — https://health-products.canada.ca/dpd-bdpp/
[4] Health Canada, Drug Establishment Licences — https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences.html