Early Access to Medicines Scheme in Saudi Arabia

About Early Access to Medicines Scheme

UK MHRA's pathway for early access to promising unlicensed medicines.

How Early Access to Medicines Scheme works in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) operates a Personal Import / Unregistered Medicine pathway for named patients, typically requiring physician justification and hospital ethics-committee review.

Patients in Saudi Arabia seeking access under Early Access to Medicines Scheme typically follow this flow: a licensed physician in Saudi Arabia issues the prescription and clinical justification, the regulator reviews and authorises, and an authorised operator coordinates import.

Documents required in Saudi Arabia

• Physician prescription and clinical-justification letter.
• Patient identification and consent.
• Country-specific NPP/personal-import form.
• Hospital or clinic attestation where required.

Typical timeline

End-to-end 2-6 weeks in most tier 1 jurisdictions. Cellular and gene therapies may require additional ethics-committee review.

Start a request

Start a request under Early Access to Medicines Scheme in Saudi Arabia