Named-patient access in the Gulf: how a hospital imports a medicine that is not registered
A plain guide for families and doctors in Saudi Arabia, the UAE, Kuwait, Qatar, Bahrain and Oman.
Reviewed by the Reserve Meds clinical operations team on 13 October 2026.
What is named-patient access?
Named-patient access lets a hospital import a medicine that is not registered in its country, for one specific patient. In the Gulf, the medicine is usually already approved by a reference regulator such as the US FDA. The treating hospital applies to the national regulator: SFDA in Saudi Arabia, EDE in the UAE (with DoH in Abu Dhabi and DHA in Dubai), the Ministry of Health in Kuwait and Oman, MoPH in Qatar, and NHRA in Bahrain. The hospital accepts responsibility, the family gives consent, and a licensed importer brings the medicine in. This is different from expanded access or compassionate use, which mainly cover medicines that are still investigational. Typical timeline: a few weeks once the hospital file is complete (estimate, not a promise).
First question: is the medicine registered in your country?
- Yes, it is registered. The local route comes first. Your doctor prescribes it at a hospital that stocks it. Named-patient import may still help if the medicine is registered but not stocked, but your hospital decides that.
- No, but it is approved by the US FDA or another reference regulator. This is the named-patient route. The treating hospital asks the national regulator for permission to import it for one patient.
- No, and it is not approved anywhere yet. The medicine is investigational. Access is through a clinical trial or the manufacturer's expanded access program, requested by the treating doctor. Saudi Arabia also has an SFDA Special Access Program for such cases. Reserve Meds does not supply investigational medicines.
Named patient, expanded access and compassionate use: the difference
- Named-patient (unregistered) import: a medicine approved elsewhere is imported for one patient under the importing country's rules. The hospital applies to its own regulator.
- Expanded access (United States): an FDA program that lets a patient with a serious condition use an investigational medicine outside a clinical trial. The treating doctor asks the manufacturer, and the FDA must allow it.
- Compassionate use (European Union): programs that give patients access to medicines that are not yet authorized in the EU, coordinated with national authorities and the European Medicines Agency.
- SFDA Special Access Program (Saudi Arabia): SFDA's route for unregistered products, mainly those still in development, for serious or life-threatening conditions with no suitable registered alternative.
Country by country
The rules below come from regulator documents and law-firm summaries. They change. Your hospital pharmacy confirms the current procedure before filing.
Saudi Arabia
Regulator: Saudi Food and Drug Authority (SFDA)
Who applies and how:
- A licensed Saudi hospital requests the import for one named patient, on the written request of the treating consultant. A licensed importer handles transport.
- The medicine must be registered with at least one reference regulator: the US FDA, the European Medicines Agency, Health Canada, the UK MHRA, Australia's TGA, Japan's PMDA or Swissmedic.
- For a medicine with no reference approval, such as a product still in trials, SFDA runs a separate Special Access Program through its clinical trials department. The drug's sponsor usually applies; a treating doctor may apply directly only if there is no sponsor.
Documents usually needed:
- Clinical letter and prescription from the treating consultant
- Hospital declaration accepting responsibility for safe use
- Importer declaration covering quality during transport and supply
- Written consent from the patient or legal guardian
- For the Special Access Program: a cover letter, a request form signed by the treating doctor, and signed consent for each named patient
Typical timeline SFDA does not publish a fixed time for named-patient imports of FDA-approved medicines. We give you a written timeline estimate for your case before you commit. This is an estimate, not a promise.
Sources: PharmaKnowl, SFDA, Saudi Food and Drug Authority (SFDA).
United Arab Emirates
Regulator: Emirates Drug Establishment (EDE); Department of Health Abu Dhabi (DoH); Dubai Health Authority (DHA)
Who applies and how:
- The Emirates Drug Establishment is the federal medicines regulator, created by Federal Decree No. 28 of 2023. It takes over the medicines role of the Ministry of Health and Prevention (MOHAP).
- Medicines normally must be registered before use. For an unregistered medicine, the treating hospital applies for approval to import it for its patient. Applications usually come from the hospital's medical director or the head of the department.
- Hospitals in Abu Dhabi are licensed by DoH, and DoH publishes data on non-registered drug products used under special authorization. Hospitals in Dubai work through DHA.
Documents usually needed:
- Clinical letter and prescription
- Hospital letter of undertaking accepting responsibility for the medicine's use
- Proof that the medicine is registered in its country of origin (FDA approval helps)
- Manufacturer registration certificate and a valid certificate of analysis for the product
Typical timeline No fixed time is published. We give you a written timeline estimate for your case before you commit. This is an estimate, not a promise.
Sources: Baker McKenzie, Al Tamimi & Co, Department of Health Abu Dhabi.
Kuwait
Regulator: Ministry of Health (MOH)
Who applies and how:
- Under Ministerial Resolution No. 100 of 2023, a non-registered medicine can be brought in when it is used to diagnose, treat or prevent disease, is registered with an overseas regulator, and no alternative is available in Kuwait.
- The request goes through MOH and follows its registration and control department's requirements. The treating hospital starts it.
- MOH has also worked with manufacturers to register new specialty therapies, such as Elevidys in June 2024.
Documents usually needed:
- Clinical letter and prescription
- Evidence of registration with an overseas regulator, such as the US FDA
- The hospital's request through MOH, using the forms its registration department requires
Typical timeline No fixed time is published. We give you a written timeline estimate for your case before you commit. This is an estimate, not a promise.
Sources: Al Tamimi & Co, AAW.
Qatar
Regulator: Ministry of Public Health (MoPH), Department of Pharmacy and Drug Control
Who applies and how:
- MoPH supervises the registration and importation of medicines in Qatar.
- For a medicine that is not registered, the treating hospital asks MoPH for approval to import it for the patient. The hospital pharmacy confirms the current form and steps.
- Qatar's hospitals already give some specialty therapies. Sidra Medicine reported its tenth Elevidys gene therapy patient in April 2026.
Documents usually needed:
- Clinical letter and prescription
- The hospital's import request to MoPH
- Product details and evidence of approval by a reference regulator such as the US FDA
Typical timeline No fixed time is published. We give you a written timeline estimate for your case before you commit. This is an estimate, not a promise.
Sources: Qatar Ministry of Public Health, Qatar MoPH medication importation note (importation is supervised by MoPH), Al Jazeera.
Bahrain
Regulator: National Health Regulatory Authority (NHRA)
Who applies and how:
- Under NHRA Circular No. 41 of 2020, government and private hospitals must get NHRA's permission before ordering a non-registered medicine.
- The medicine must be important, with no registered alternative in Bahrain. It must be registered with the Gulf Health Council or a GCC country, or with a listed authority such as the US FDA, Health Canada, the European Medicines Agency, Swissmedic, TGA, PMDA or MHRA, and be marketed in its country of origin.
- Some medicines for rare, emergency and cancer cases with no registered alternative can be exempt from parts of these conditions, by NHRA's list or Board approval.
Documents usually needed:
- Application form
- A Certificate of Pharmaceutical Product (CPP) or registration certificate from a listed country or authority
- A Good Manufacturing Practice (GMP) certificate for the manufacturer
Typical timeline No fixed time is published in the circular. We give you a written timeline estimate for your case before you commit. This is an estimate, not a promise.
Sources: NHRA Bahrain.
Oman
Regulator: Ministry of Health, Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC)
Who applies and how:
- Medicines are registered with the Ministry of Health. In exceptional cases, special permission can be given to import a product when there is a specific patient need and no suitable product is available locally.
- It generally applies to rare or exceptional conditions. Prior approval by regulators in the US, UK or Western Europe makes importation easier.
- Ask the treating hospital's pharmacy which office and form apply today.
Documents usually needed:
- Clinical letter and prescription
- Evidence of approval by a reference regulator such as the US FDA
- The request for special import permission, prepared with the hospital or the supplier
Typical timeline No fixed time is published. We give you a written timeline estimate for your case before you commit. This is an estimate, not a promise.
Sources: Al Tamimi & Co.
What every route has in common
- The treating doctor decides whether the medicine is right for the patient.
- The hospital or its licensed importer applies. Families do not apply alone.
- The regulator decides. Nobody can guarantee approval.
- The medicine goes to the hospital, not to a home address.
- Be careful with online sellers who offer to ship unregistered medicines directly. That is not a legal route.
How Reserve Meds helps
Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We coordinate access to FDA-approved medicines only. We help your doctor and hospital prepare the request, arrange US supply and shipping once approval is in place, and keep your family updated. We do not prescribe or give medical advice. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.
Ask about a medicine
Tell us the medicine and your country. We reply within one business day. On WhatsApp we usually reply the same day.
Frequently asked questions
What is a named-patient program?
It is a legal way for a hospital to import a medicine that is not registered in its country, for one named patient, with the national regulator's permission. In the Gulf it is usually used for medicines already approved by the US FDA or another reference regulator.
How is named-patient access different from expanded access?
Expanded access is a US FDA program for investigational medicines that are not yet approved. The treating doctor asks the manufacturer, and the FDA must allow it. Named-patient import is usually for a medicine that is already approved somewhere, brought into a country where it is not registered.
Is compassionate use the same as named-patient access?
Not exactly. In the European Union, compassionate use programs give patients access to medicines that are not yet authorized. People often use the words loosely, so ask your hospital which route it means.
Can a family apply to the regulator directly?
Usually no. In each Gulf country we describe here, the treating hospital or its importer applies, on the request of the treating doctor. The family gives consent and supplies documents.
Can Reserve Meds supply medicines that are not approved anywhere?
No. We coordinate access to FDA-approved medicines only. A medicine still in trials is only available through the manufacturer's expanded access program, requested by the treating doctor. We can explain that route, but we do not supply those medicines.
If a medicine is already registered in my country, do I need named-patient access?
Usually not. If it is registered, the local route comes first: a prescription at a hospital that stocks it. Named-patient import is for medicines that are not registered, or in some countries not available, locally.
Sources
Checked on 13 October 2026. Regulator rules change. Your hospital pharmacy confirms the current procedure before filing.
- FDA: Expanded Access (how to request investigational drugs outside clinical trials)
- European Medicines Agency: compassionate use
- PharmaKnowl: Named Patient Program in Saudi Arabia (reference regulators, hospital and importer declarations, patient consent)
- SFDA: Special Access Program (SAP) guidance, version 1.0
- Saudi Food and Drug Authority (SFDA)
- Baker McKenzie: new Emirates Drug Corporation replaces MOHAP as federal regulator of medical products (Federal Decree No. 28 of 2023)
- Al Tamimi & Co: importation of unregistered drugs in the UAE (hospital letter of undertaking; registration in country of origin)
- Department of Health Abu Dhabi: drug authorization dashboard (non-registered drug products with special authorization)
- Al Tamimi & Co: Kuwait Ministry of Health restrictions on the supply of non-registered medical products (Resolution No. 100 of 2023)
- AAW: with the Ministry of Health, AAW and Roche introduce Elevidys to Kuwait, 23 Jun 2024
- Qatar Ministry of Public Health: services for companies (pharmacy and drug control)
- Qatar MoPH medication importation note (importation is supervised by MoPH)
- Medicine price: quote on request. You get a written quote for your case before you commit.
- NHRA Bahrain: Circular No. (41) 2020, procedures for importing non-registered medicines
- Al Tamimi & Co: pharmaceutical registration in Oman, an overview (special permission to import in exceptional cases)