Special access routes for unregistered medicines in the GCC

The six Gulf Cooperation Council states share a common external tariff, but they do not share a single route for medicines that are not registered locally. Each national regulator decides who may import an unregistered medicine, on what grounds and with which documents. For a hospital, distributor or exporter, the practical question is always the same: which licensed local party holds the approval, and is it in place before the goods leave India?

This guide compares the routes in the United Arab Emirates, Saudi Arabia, Oman, Qatar and Kuwait, with a short note on Bahrain. The country guides for the UAE, Saudi Arabia, Oman, Qatar and Kuwait give fuller detail.

What the GCC routes have in common

• Registration comes first. Every country starts from the rule that a medicine is registered before it circulates. Unregistered access is an exception that needs a written approval.
• A licensed local party applies. The applicant is a hospital, a licensed warehouse or distributor, or the national public provider, never the overseas exporter.
• Approval before shipment. Saudi Arabia, for example, requires SFDA approval before the purchase order is issued.
• Release at the port. Regulators inspect and release each consignment on arrival, so the documents must match the approval exactly.
• Separate controlled-drug permits. Narcotic and psychotropic medicines follow their own permit track in each country.
• Clinical reasons. Routes are written for patients with no registered alternative, not for lower-cost sourcing. See how named-patient supply works.

Country comparison

Country by country

United Arab Emirates

The Emirates Drug Establishment is the federal medicines regulator. On 29 December 2025 MOHAP transferred 44 core services to EDE, including import permits and marketing authorisations. Registered products move under EDE's two-stage import permit, an initial permit in 3 working days and a shipment clearance permit in 2.

For unregistered products, a health facility applies for approval where no registered alternative exists. The DHA Pharmacy Guidelines list four grounds in Dubai: no registered alternative, discontinued or interrupted supply, quality or safety concerns about the registered brand, and emergencies. An authorised distributor imports against the facility's justification letter, for no more than six months of expected consumption. The guidelines date from 2021 and name MOHAP, so confirm the current filing channel with EDE. Abu Dhabi facilities also follow the Department of Health formulary. Residents can apply for EDE's free personal-use import permit, which is mandatory for narcotic and psychotropic medicines and limited to three months of need.

Saudi Arabia

In June 2025 the SFDA published a mechanism for importing and clearing unregistered medicines for specific patients and special cases in hospitals. The hospital obtains approval before issuing the purchase order, justifies the import and discloses any registered alternative, and the facility and importer each sign an undertaking.

The Special Access Program guideline, version 2.0 dated October 2026, covers serious or life-threatening conditions, including rare diseases. The medicine must be registered for the same indication, dose and route with the US FDA, EMA, MHRA, PMDA, Health Canada, Swissmedic or TGA. The SFDA aims to decide within 7 working days, and the hospital or physician then requests the import licence. Individuals may clear up to three months of a non-controlled prescription medicine sent by courier under the personal-use conditions, which exclude narcotics, psychotropics, vaccines and plasma-derived products.

Oman

The Ministry of Health's Drug Safety Center runs an Import of Non Registered Drug e-service. A licensed pharmaceutical warehouse with a purchase licence files it for a public or private health institution. No fee is listed and the completion time is about one week. The detailed conditions sit in a guideline brought into force by Circular No. 17 of 2024. Each batch then needs customs release, listed at one working day and 5 rials per batch, and the invoice must be certified by the source.

Qatar

Every import needs prior approval from the Department of Pharmacy and Drug Control through the Pharmacy e-System, which the Sharek service page lists as free. A ministerial decision reported by Al Raya in October 2022 lets Hamad Medical Corporation import unregistered medicines with prior Ministry approval when there is an urgent public health need, a technical problem with a registered medicine, or a patient continuing treatment started abroad. The medicine must be registered in its country of origin and have no registered equivalent in Qatar. No equivalent route for private hospitals was found, so a private facility should ask the Department first.

Kuwait

In 2023 Resolution 100 of 2023 repealed a 2022 mechanism for importing non-registered medicines. A medicine registered with international regulators, with no alternative in Kuwait, can instead be registered at the request of Ministry authorities. No current single-patient procedure was found, so a hospital should ask the drug control administration in writing which route it accepts, and the exporter should ship only against a written approval naming the consignee.

Bahrain

A Supreme Council for Health decision reported by Zawya requires unregistered medicines imported for government and private health institutions to be registered with the GCC central registration committee or one of several listed regulators. Rare disease, emergency and oncology products are among the exemptions. The decision date was not shown, so confirm the current rule locally.

How a Gulf hospital request usually runs

1. The treating physician writes the justification. It covers the diagnosis, the reason no registered product is suitable and the quantity needed.
2. The hospital pharmacy picks the applicant. This is the hospital with its licensed importer in Saudi Arabia, Hamad Medical Corporation in Qatar, a licensed warehouse in Oman, and usually an authorised distributor in the UAE.
3. The exporter supplies the dossier. A supplier in India issues a proforma invoice showing origin, batch numbers and dates, plus the certificate of analysis, GMP certificate and proof of registration in the country of origin. The document checklist lists the items per country.
4. The applicant files with the regulator. Reference-authority evidence is added where the route needs it, as in the SFDA programme.
5. The approval arrives and the purchase order follows. In Saudi Arabia the order must not come first.
6. The exporter clears Indian controls and ships. Unapproved or new drugs in India need a CDSCO export no objection certificate, explained in Indian export rules buyers should know.
7. The regulator releases the consignment at the port. The goods then go to the hospital pharmacy.

Planning totals are roughly 2 to 5 weeks for the UAE, Oman and Qatar, 3 to 7 weeks for Saudi Arabia and 5 to 10 weeks for Kuwait. These are estimates, not published service times, and the lead-time estimator breaks them down.

Shelf life, cold chain and tax

• Shelf life. Qatar requires two thirds of shelf life remaining on arrival under an April 2026 circular, with exemptions requested before arrival. See shelf-life requirements in medicine supply.
• Heat. Direct flights from India are short, but summer apron temperatures in the Gulf often pass 45°C. Cool-room handling at the arrival airport and passive shippers qualified for a summer profile reduce excursion risk. The cold-chain transit checker compares hold times with each lane.
• Duty. World Bank WITS data shows 0 percent duty on HS 3004 medicines under the GCC common tariff in all five countries.
• VAT. The UAE zero-rates medicines registered or imported with the authority's permission, with new wording in force from 1 October 2026, Saudi Arabia charges 15 percent with zero-rating for qualifying medicines, Oman sets a zero-rated list from 1 October 2026, and Kuwait and Qatar have not introduced VAT. The landed cost calculator applies these rates.