Special Access Scheme: how it works and where it is recognized
A cross-border regulatory framework for supplying an unregistered or off-label medicine to a specific patient, on the order of a treating physician, under a defined permit issued by the destination-country medicines regulator.
Last reviewed 2026-05-16 by Reserve Meds clinical and regulatory team.
What SAS is
Origin and authorising body. Australia, under Section 19(5) of the Therapeutic Goods Act 1989; parallel frameworks operate in New Zealand, Canada (Health Canada Special Access Programme), and several other Commonwealth jurisdictions. The authorising body for each individual case is the Therapeutic Goods Administration (TGA) for Australia; equivalent regulators in other Commonwealth jurisdictions, acting under that jurisdiction's pharmacy or medicines legislation.
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Legal basis. The Therapeutic Goods Administration's Special Access Scheme operates under Section 19(5) of the Therapeutic Goods Act 1989, authorising the supply of unapproved therapeutic goods to a single patient or a small number of patients on a case-by-case basis. SAS Category A covers seriously ill patients (notification-only), Category B covers other patient categories (TGA approval required before supply), and Category C covers products on an established list (notification with structured oversight).
Special Access Scheme is the Australian framework for individual-patient supply of unapproved therapeutic goods. The three-category structure (A, B, C) creates a graduated oversight model: emergency or seriously ill cases proceed on notification only, routine cases require TGA approval, and a defined list of established products operates under structured notification. The framework is well used and operationally efficient.
Category A (seriously ill patients) operates on notification: the prescriber notifies the TGA within 28 days of supply but does not need pre-authorisation. Category B (other patients) requires TGA approval before supply, typically within 1 to 2 weeks. Category C (established list, including HIV antiretrovirals, certain oncology agents, and other products with established access patterns) operates with notification and structured oversight. Australian pharmacists and specialty importers operate established workflows for routine SAS cases.
This page consolidates Reserve Meds's operational view of the Special Access Scheme framework across the ten destination countries where we currently coordinate cross-border supply. Earlier in our content build we maintained separate per-country sub-pages for each Special Access Scheme-in-country combination; those sub-pages remain available for archival reference but are no longer separately indexed, and the operational intelligence they carried has been folded into the country-compatibility table below.
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Who can use SAS
SAS is used by Australian medical practitioners on behalf of patients in Australia. Cross-border patients cannot directly use the framework.
In practical terms, a Reserve Meds case opens when the treating physician has identified the clinical need, has reached a decision to prescribe a specific medicine, and has determined that the locally available route is unsuitable or unavailable. We then layer the regulatory and supply-chain coordination on top of that clinical decision; we do not originate the prescribing question and we do not advise on the clinical choice. The decision sits with the physician throughout.
Drug categories typically covered under SAS
Specialty oncology agents, rare-disease biologics, advanced therapy medicinal products, HIV antiretrovirals (Category C), paediatric formulations, and post-approval indications not yet through TGA registration.
The medicine itself must be source-country approved or in active regulatory development under a recognised reference authority (typically the US FDA, the European Medicines Agency, the UK MHRA, the Japan PMDA, or Health Canada). Most destination regulators will not authorise a Special Access Scheme import for a medicine that lacks a recognised reference authorisation anywhere in the world, because the regulator's risk assessment leans on the source-country review as a substitute for its own.
Country compatibility
The table below summarises how the Special Access Scheme framework is recognised across the ten destination countries where Reserve Meds currently coordinates cross-border supply. The "Accepts Special Access Scheme dossiers" column reflects whether the destination regulator typically reviews and grants permits on the strength of a Special Access Scheme clinical justification packet, or whether the patient must use a different parallel framework on the receiving side. Timelines reflect routine cases with a complete documentation set; first-import scenarios, paediatric weight-banded presentations, advanced therapy medicinal products, and large multi-cycle quantities can extend the regulator review by several weeks.
| Country | Local pathway equivalent | Accepts Special Access Scheme dossiers? | Typical timeline | Local regulator |
|---|---|---|---|---|
| Bahrain | NHRA Compassionate / Special Import Permit | Indirect (reference precedent only) | 5 to 15 business days | NHRA |
| Egypt | EDA Single-Patient Import (Decree 425) | Indirect (reference precedent only) | 10 to 25 business days | EDA |
| India | Rule 36 personal-use import (D&C Rules 1945) | Indirect (reference precedent only) | 7 to 21 business days | CDSCO |
| Jordan | JFDA Compassionate / Special Use Import | Indirect (reference precedent only) | 10 to 20 business days | JFDA |
| Kuwait | MoH Unregistered Medicine Import Permit | Indirect (reference precedent only) | 10 to 20 business days | KDFC (MoH) |
| Lebanon | MoPH Special Import for Named Patient | Indirect (reference precedent only) | 10 to 25 business days | MoPH |
| Oman | MoH Compassionate / Named-Patient Import | Indirect (reference precedent only) | 10 to 20 business days | MoH-DGPADC |
| Qatar | MoPH Single-Patient Unregistered Drug Import | Indirect (reference precedent only) | 10 to 20 business days | MoPH-DPA |
| Saudi Arabia | SFDA Personal Importation Permit | Indirect (reference precedent only) | 10 to 25 business days | SFDA |
| United Arab Emirates | EDE Unregistered Medicine Import Permit | Indirect (reference precedent only) | 5 to 15 business days | EDE |
Notes. "Indirect" means the destination regulator does not directly accept Special Access Scheme authorisation as the legal basis for import but does recognise a Special Access Scheme authorisation as supporting precedent within its own named-patient or compassionate-use review. "Not applicable" means the framework is not a patient-access pathway in the cross-border sense and is shown here for completeness. Regulator names: NHRA (Bahrain), EDA (Egypt), CDSCO (India), JFDA (Jordan), KDFC (Kuwait), MoPH (Lebanon), MoH-DGPADC (Oman), MoPH-DPA (Qatar), SFDA (Saudi Arabia), and EDE (United Arab Emirates, federal from 29 December 2025).
Documentation required
A SAS application is typically assembled in coordination with the treating physician, the dispensing facility, and the cross-border supply partner. The documentation set below covers the routine case; specific destination countries may require additional items (most frequently a hospital ethics committee notification for paediatric or complex cases, and an insurer pre-authorisation letter where the patient intends to seek reimbursement).
- Prescriber's SAS application (Form A, B, or C as applicable).
- Patient clinical history.
- Informed consent.
- Pharmacy dispensing plan.
- For Category A: post-supply notification within 28 days.
Typical timeline
Category A: notification only, supply can proceed immediately. Category B: TGA review typically 1 to 2 weeks. Category C: notification within structured timelines. End-to-end: 2 to 8 weeks depending on category and source country.
Costs and reimbursement
Australian Pharmaceutical Benefits Scheme (PBS) may cover SAS medicines for listed indications; private payment otherwise. Cross-border patients pay the relevant per-country acquisition cost.
Where Reserve Meds fits in
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine access. For Special Access Scheme cases, we coordinate the US-side sourcing through a DSCSA-compliant specialty channel, prepare the documentation packet your physician submits, coordinate validated cold-chain logistics with continuous temperature logging into the destination country, and assign a single named coordinator through the case. We do not replace your treating physician, we do not replace the destination-country regulator, and we do not replace your dispensing pharmacy. We coordinate the supply side so the physician can focus on patient care.
For each of the ten destination countries above, we publish a country-specific page documenting the operational realities (which dispensing facilities handle named-patient cases, how the cold chain is verified at the local airport, how the dispensing pharmacy releases the medicine, and what the typical insurer interaction looks like). Those country pages, combined with this pathway page and the specific drug pages, give the prescribing physician and the patient a coherent picture of what to expect before any commitment is made.
Our concierge fee is itemised separately on every firm quote alongside the drug acquisition cost, international logistics, customs, and dispensing pharmacy handling. The patient sees the full breakdown before deciding to proceed; we do not bundle costs and we do not charge an intake deposit. If the case cannot proceed for regulatory or supply reasons, we say so before any payment is taken.
Next step
If your treating physician has identified a clinical need that fits the Special Access Scheme framework and you are weighing the cross-border route, the next step is a short intake. We confirm eligibility within 24 to 48 hours and send a documentation kit to your physician.
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