KODC Statutory Import & Supply – South Korea

KODC Drug Purchase Application (의약품 구입신청)Pharmaceutical Affairs Act Art. 91 (establishment of KODC); Art. 92 (functions)

Description & Eligibility

The Korea Orphan & Essential Drug Center is the government-established body that imports and supplies orphan drugs and national essential drugs that are not commercially distributed in Korea. It supplies both clinical sites (emergency introduction) and individual patients (self-treatment drugs), and is for many rare-disease patients the only lawful supply route.

Eligibility Criteria

Orphan or national essential drugs not commercially distributed in Korea; application supported by a diagnosis certificate and prescription

Legal Reference / Source

KODC — Purchase Application Guide

www.kodc.or.kr/cntnts/185

Countries Using This Pathway (1)

KODC Statutory Import & Supply – South Korea
Approval FormKODC Drug Purchase Application (의약품 구입신청)
Legal StatusPharmaceutical Affairs Act Art. 91 (establishment of KODC); Art. 92 (functions)
Source Ref.KODC — Purchase Application Guide
Countries1 countries
Compliance Check
Legal Review9/1/2026
Global ValidityVerified