Your medicine is not registered in your country: the legal options

Creator: Reserve Meds
Published: 2026-10-17

A practical guide for families in Saudi Arabia, the UAE, Bahrain and the wider Gulf, with each rule linked to the regulator.

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

The short answer

When a US-approved medicine is not registered in your country, you usually have five legal options: confirm the register first, ask the treating hospital to request it for you as a named patient, import it for personal use where the rules allow, receive it at a qualified center abroad, or, if it is not approved anywhere, ask about a trial or expanded access. The right one depends on the medicine and how it is given.

Option 1: Check whether it is already registered or listed.
Option 2: A hospital named-patient or special access request to the regulator.
Option 3: Personal-use import, for medicines the rules allow.
Options 4 and 5: Treatment at a center abroad, or a trial or expanded access.

Why a US-approved medicine may not be registered locally

Registration is not automatic. The manufacturer or its agent has to apply in each country. Saudi Arabia's SFDA runs reliance pathways with performance targets of 30 working days when a medicine is approved and marketed by both the US FDA and the EMA, and 60 working days when it has one of them, but only once the company applies.^[1]

New, rare-disease and specialty medicines are often registered late, or not at all, in smaller markets. That gap is what the options below are for.

Option 1: check the register before anything else

In Saudi Arabia, the SFDA's public Drugs List can be searched by trade name, scientific name or registration number. In Abu Dhabi, the Department of Health publishes a drug code list. A listing does not mean every hospital stocks the medicine, but it means the hospital can usually order it locally, which is faster and simpler than any import.^{[2, 3]}

Option 2: a hospital named-patient or special access request

In Saudi Arabia, the SFDA Special Access Program lets a patient with a serious or immediately life-threatening condition receive a medicine that is not registered when no comparable alternative exists. The request comes from the manufacturer or sponsor, or from the licensed treating physician if there is no sponsor. We give you a written timeline estimate for your case before you commit.^[4]

In Bahrain, NHRA Circular 41 of 2020 lets government and private hospitals import a non-registered medicine with the authority's permission before the purchase order, when the medicine is important and has no registered alternative in Bahrain, is registered with the Gulf Health Council, a GCC state or a reference regulator such as the US FDA, and is marketed in its country of origin.^[5]

Other Gulf countries have their own procedures, which the hospital pharmacy confirms. In the UAE, federal medicine regulation is moving from the Ministry of Health and Prevention to the Emirates Drug Establishment under Federal Decree-Law No. 38 of 2024, in force from 2 January 2025.^[6]

This is the usual route for injected, infused or hospital-only medicines.

Option 3: personal-use import, when the medicine qualifies

Saudi Arabia allows personal-use clearance of non-controlled prescription medicines, sent by courier or post, for up to three months of use, with a prescription or medical report approved by the treating institution within the last six months. Vaccines and medicines that must be used under medical supervision cannot be cleared this way.^[7]

The UAE has a free electronic service, Issue of Permit to Import Medicines for Personal Use. The core document is a prescription issued within the last three months, stamped by the facility where the patient is followed, showing the patient's name, medicine, dose, form, duration, date and physician.^[8]

Option 4: treatment at a qualified center abroad

Cell and gene therapies are made for one patient or given through a specialized procedure, and are usually available only at treatment centers the manufacturer has qualified. FDA's list of approved cellular and gene therapy products shows how many such treatments now exist. For these, the realistic route is often a referral to a center abroad.^[9]

Option 5: medicines not approved anywhere

If a medicine is still investigational, the options are a clinical trial or US expanded access. Expanded access needs the manufacturer's agreement and FDA authorization, requested by the treating physician. FDA allowed almost all single-patient requests it received in fiscal year 2023, but manufacturers are not obliged to supply.^{[10, 11]}

A patient abroad also needs the home regulator's approval, and the export must meet FDA's rules for investigational drugs.^[12]

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.

Ask us about a medicine

Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.

Frequently asked questions

What is the fastest legal way to get an unregistered medicine in Saudi Arabia?

If it is registered, local supply. We give you a written timeline estimate for your case before you commit. Shipping and hospital steps add time.

Can I order a prescription medicine from abroad for myself?

Sometimes. Saudi Arabia allows personal-use clearance of non-controlled prescription medicines for up to three months, but not vaccines or medicines that need medical supervision. The UAE has a personal import permit service.

Does the hospital or the family apply to the regulator?

For named-patient and special access routes, the hospital or treating physician applies. For personal-use import, the patient or guardian applies.

What if the medicine is not approved anywhere?

Ask the treating doctor about clinical trials or US expanded access, which needs the manufacturer's agreement, FDA authorization and your own regulator's approval.

Sources for these answers: ^{[4, 7, 8, 10]}

Sources

All sources were opened and checked on 17 October 2026. Rules and labels change, so the treating hospital or regulator confirms the current position before anything is filed.

SFDA: Verification and Abridged Pathways guidance, version 3.0 (October 2025) (accessed 17 October 2026)
SFDA: Drugs List (public register search) (accessed 17 October 2026)
Department of Health Abu Dhabi: drug code list (release 26 September 2026) (accessed 17 October 2026)
SFDA: Special Access Program (SAP) guidance, version 1.0 (accessed 17 October 2026)
NHRA Bahrain: Circular No. (41) of 2020, procedures for importing non-registered medicines (accessed 17 October 2026)
Baker McKenzie: UAE enacts new pharma law (Federal Decree-Law No. 38 of 2024), 14 January 2025 (accessed 17 October 2026)
SFDA: Conditions and Requirements for the Clearance or Exportation of Individuals for Personal Use, version 1.1 (accessed 17 October 2026)
UAE Ministry of Health and Prevention: Issue of Permit to Import Medicines for Personal Use (service page) (accessed 17 October 2026)
US FDA: Approved Cellular and Gene Therapy Products (accessed 17 October 2026)
US FDA: Expanded Access (accessed 17 October 2026)
US FDA: Expanded Access (Compassionate Use) Submission Data (accessed 17 October 2026)
US FDA: Exporting Investigational New Drugs (accessed 17 October 2026)

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