Yemen

Middle East

Contents

1. Regulatory Overview
2. Regulatory Pathways

Regulatory Overview

Yemen is regulated by the SCAMA (Supreme Council for Medicines and Medical Devices). The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.

Regulatory Authority

SCAMA (Supreme Council for Medicines and Medical Devices)

Regulatory Pathways (1)

Yemen MOH Special Import Authorization 45 days

Yemen Ministry of Health special import authorization for access to medicines not registered in Yemen for patients with serious medical conditions.

Application Form: MOH Yemen Special Import Form

Legal Basis: Yemen Drug Regulations

Eligibility: Serious or life-threatening condition with no locally registered alternative

Reference: SCAMA Drug Access Policy

Yemen

ISO Code	`YE`
Region	Middle East
Regulatory Authority	SCAMA (Supreme Council for Medicines and Medical Devices)
Pathways	1 documented
Drugs Available	0 documented