Importing medicines into Saudi Arabia

The regulator

The Saudi Food and Drug Authority (SFDA) registers medicines and controls their import, clearance and distribution. Its Drug Sector evaluates products and runs the clinical trial and special access programmes, while the Drug Permits Department in the Operations Sector issues import licences and SFDA port offices clear each consignment. The SFDA drug import and export procedures manual sets out these steps and includes the standard forms. Controlled medicines are handled through SFDA's Controlled Drugs System.

Government hospitals mostly receive medicines through NUPCO, the national unified procurement company. Its tender rules require products offered in unified tenders to be registered with SFDA, so unregistered specialty medicines normally reach patients through a hospital request rather than a tender.

Legal routes for unregistered medicines

SFDA regulations require a drug to be registered before it is marketed. There are two main exceptions for hospitals, and a separate concession for individuals.

Named-patient imports by hospitals

In June 2025 SFDA published a simplified mechanism for importing and clearing unregistered medicines for specific patients and special medical cases in hospitals. The hospital must obtain SFDA approval before issuing the purchase order, justify the import and tell SFDA about any registered alternative in the Kingdom. SFDA states that it does not vouch for the safety or efficacy of unregistered products, so the importing facility takes responsibility and keeps patient and product records. The document is in Arabic and also refers to the reference authorities listed below, so check whether the product needs one of those approvals.

The SFDA application form for an unregistered medicinal product asks whether the request is for a named patient or for buffer stock, and the treating physician signs a declaration accepting responsibility and agreeing to keep the patient's name, ID number and contact details.

Special Access Program

The Special Access Program guideline, version 2.0 dated October 2026, covers serious, debilitating or life-threatening conditions, including rare diseases, where registered therapies have failed or are unsuitable. The medicine must be registered for the same indication, dose and route with a reference regulatory authority: the US FDA, EMA, MHRA, PMDA, Health Canada, Swissmedic or TGA. The sponsor files an Arabic-headed cover letter, the SAP form, a protocol, the investigator's brochure, a consent form and an ethics or pharmacy and therapeutics committee approval. SFDA aims to decide within 7 working days and issues a no-objection letter. The hospital or physician then requests the import licence through the SFDA Faseh system. Serious unexpected reactions must be reported within 15 days, or 7 days if fatal or life-threatening.

Personal use

SFDA's personal-use clearance conditions let an individual clear prescription medicines sent by courier with a medical report, ID, invoice and bill of lading, capped at three months of use. Narcotic and psychotropic medicines cannot travel by courier, and vaccines, plasma-derived products and medicines needing medical supervision are excluded. SFDA issued version 3.0 of these conditions in Arabic in 2025.

Documents a buyer usually needs

• SFDA prior approval for the unregistered medicine, issued before the purchase order
• SFDA application form and the declaration and undertaking forms from the facility and the importer
• Physician justification with the reasons a registered product is not suitable
• Evidence of approval by a reference authority where the route requires it
• Proforma invoice, commercial invoice and packing list with matching details
• Certificate of analysis for each batch, a GMP certificate and a certificate of pharmaceutical product
• Air waybill and, for SAP supply, the SFDA no-objection letter

Timeline: a worked example

A hospital in Riyadh needs a medicine approved by the EMA but not registered with SFDA for a named patient.

Total: roughly 3 to 7 weeks from request to delivery. These are planning estimates, not published service times.

Shipping lanes from India

Riyadh (RUH), Jeddah (JED) and Dammam (DMM) have daily direct flights from Mumbai, Delhi, Hyderabad, Bengaluru, Chennai, Kochi, Kozhikode, Lucknow and other Indian cities. Express courier service is usually 3 to 5 days door to door for small, non-controlled parcels. Air cargo is usually 4 to 9 days including SFDA port clearance. Choose the arrival airport closest to the hospital, since SFDA clears at the port of entry.

CIP and DAP are the usual terms, and FCA suits importers with their own forwarder. DDP is rarely practical because the Saudi consignee holds the SFDA approval.

Practical tips for buyers

• Do not issue the purchase order before SFDA approval. The 2025 mechanism makes prior approval a condition.
• Check reference-authority status early. A medicine approved only in India may not qualify for the Special Access Program.
• Duty on HS 3004 medicines is 0 percent according to World Bank WITS data for the GCC common tariff.
• The standard VAT rate is 15 percent, and qualifying medicines and medical equipment are zero-rated. Whether an unregistered import qualifies was not confirmed, so ask a tax adviser.
• Tender supply through NUPCO requires SFDA registration, so plan registration if repeat government volumes are expected.