Austria

Europe

Contents

1. Regulatory Overview
2. Regulatory Pathways
3. Available Drugs

Regulatory Overview

Austria is regulated by the AGES (Austrian Agency for Health and Food Safety). 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

AGES (Austrian Agency for Health and Food Safety)

Regulatory Pathways (1)

Austria Compassionate Use (Article 83 EMA) 30 days

EMA Article 83 compassionate use framework allowing access to unauthorised medicinal products for groups of patients with a chronically or seriously debilitating or life-threatening disease in Austria.

Application Form: National compassionate use form

Legal Basis: Regulated under EU Directive 2001/83/EC

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

Reference: EMA Article 83 Compassionate Use

Drugs Available (2)

Drug	Access Route	Status	Lead Time
idebenone	—	—	—
Cerebrolysin	—	—	—

Austria

ISO Code	`AT`
Region	Europe
Regulatory Authority	AGES (Austrian Agency for Health and Food Safety)
Pathways	1 documented
Drugs Available	2 drug(s)