Section 21 (South Africa) in Saudi Arabia

About Section 21 (South Africa)

South Africa's SAHPRA pathway for access to unregistered medicines.

How Section 21 (South Africa) 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 Section 21 (South Africa) 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 Section 21 (South Africa) in Saudi Arabia