EU compassionate use under Article 83 of Regulation 726/2004

Reviewed by the Reserve Meds clinical operations team on 17 October 2026. Sources accessed 17 October 2026.

What Article 83 does

EMA provides recommendations through its Committee for Medicinal Products for Human Use (CHMP), but these do not create a legal framework. Compassionate use programmes are coordinated and implemented by member states, which set their own rules and procedures.^[1]

Article 83 is designed to improve patient access to compassionate use programmes in the EU, to encourage a common approach on conditions of use, distribution and the patients targeted, and to increase transparency between member states about treatment availability.^[1]

Who can benefit

Programmes are only put in place if the medicine is expected to help patients with life-threatening, long-lasting or seriously debilitating illnesses that cannot be treated satisfactorily with any authorised medicine. The medicine must be in clinical trials or have entered the marketing authorisation process; its safety profile and dosing may not yet be fully established.^[1]

EMA says patients should always be considered for clinical trials before compassionate use programmes.^[1]

Compassionate use is not the same as named-patient supply

EMA distinguishes compassionate use from treatment on a named-patient basis, where a doctor obtains a medicine directly from the manufacturer before authorisation, for an individual patient, under the doctor's direct responsibility. EMA does not need to be informed of named-patient treatment.^[1]

Once a medicine is authorised, EMA does not update its compassionate use recommendations, because the European public assessment report covers the medicine, although national programmes may continue until the medicine is on the market.^[1]

What this means for patients outside the EU

EU compassionate use programmes are run by member states for patients in those states. A patient in the Gulf generally cannot join one from home.

Until a medicine is registered locally, a patient in the Gulf usually reaches an FDA-approved medicine through a hospital request to the national regulator, such as the SFDA Special Access Program in Saudi Arabia or the procedure in NHRA Circular 41 of 2020 in Bahrain.^{[2, 3]}

If the medicine is already approved by the US FDA, the local route above is normally the practical one. If it is not approved anywhere, the treating doctor can ask the manufacturer about a trial or about US expanded access, which also needs FDA authorization and the destination regulator's agreement.^{[4, 5]}

If the medicine is only available through US expanded access

For a single patient, the treating physician can request expanded access from FDA using Form FDA 3926, the Individual Patient Expanded Access IND, and physicians can now submit non-emergency individual patient requests through FDA's Expanded Access eRequest system.^[6]

The physician must first confirm the company will provide the product, then obtain Institutional Review Board review and the patient's informed consent. A non-emergency request takes effect 30 days after FDA receives it, or sooner if FDA says treatment can begin.^{[7, 8]}

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We help families and treating doctors understand the route, prepare the documents the regulator or hospital asks for, arrange supply from the US once approval is in place, and keep everyone updated. We do not diagnose, prescribe or decide what a regulator approves.

We coordinate access to FDA-approved medicines only. Investigational medicines are only available through a manufacturer's expanded-access program requested by the treating physician; we can explain that route, but we do not supply them. Your coordination fee is quoted in writing for your case before you commit. No hidden charges. We give you a written timeline estimate for your case before you commit.

Sources for these answers: ^{[1, 2]}

Related

• EU conditional marketing authorisation
• EMA PRIME scheme
• All access pathways
• US expanded access (compassionate use)
• Named-patient access, explained
• Answers to common access questions

This page is general information, not medical or legal advice. It does not replace advice from your own doctor or the regulator.