Patient with a serious condition and no suitable treatment: a practitioner may request a non-marketed drug
Patient with a serious condition and no suitable treatment: a practitioner may request a non-marketed drug
Patients cannot apply directly and authorization does not require a manufacturer to supply the drug. Use the emergency contact for a critical case.
Confirm the scope
Confirm the serious or life-threatening condition and document why conventional treatments failed, are unavailable or unsuitable.
Prepare the information
Confirm supply and quantity with the manufacturer and gather the clinical rationale, dosing, risks and consent information.
Complete the process
The practitioner completes and signs the patient-specific or future-use form and sends it through the stated SAP channel.
Keep follow-up records
Await the decision, coordinate import and payment, and meet recordkeeping, follow-up and adverse-reaction reporting duties.
Request a drug through the Special Access Program — Health Canada