Import Notification in Austria

In accordance with the Austrian Medicinal Products Importation Act (Arzneiwareneinfuhrgesetz, AWEG), Federal Gazette No. 79/2010, the right to submit import notifications or applications for import licenses is limited to:

• public pharmacies or
• hospital pharmacies or
• companies holding a license for the distribution of medicinal products or blood products in any of the contracting parties to the European Economic Area (EEA)

When filing an application for an import certificate or a certificate of marketability, companies from a member state of the EEA have to submit convincing evidence of their national license in accordance with the applicable medicines legislation.

When submitting an import notification, the Federal Office for Safety in Health Care (BASG) / Austrian Medicines and Medical Devices Agency (AGES) will determine whether the notifying party or applicant holds such a license.

A Clinical Research Organization (CRO) may not submit a transport notification or file an application for an import certificate or a certificate of marketability unless it holds a license for the sale of medicinal products.

Private individuals are not entitled to submit an import notification or apply for an import certificate or a certificate of marketability.