In an arbitration process, the Federal Office for Safety in Health Care (BASG) was obliged according to § 14 of the Federal Disability Equality Act (BGStG) to request Holders of a Marketing authorization/Registration/Parallel import license to provide their Package Leaflets (PL) in an accessible format corresponding to the standard PDF-UA until 31.12.2020.

In 2017, we have received a lot of positive feedback for our first BASG-dialogue “Meet the Case Manager”. Therefore, we are very happy to announce your next chance to meet with us in person!

Also in the future, we want to continue to inform our applicants of marketing authorisation procedures with Austria as RMS with relevant news from the committees or exciting innovations such as the slot application via our eServices!

Bedingte Zulassung für Wirkstoff Remdesivir, für Erwachsene und Jugendliche ab 12 Jahren mit COVID-19 Lungenentzündung die Sauerstoff benötigen, empfohlen

Die Warnung umfasst Produkte die außerhalb von legalen Apotheken angeboten werden

Vorteilhafte Wirkung nicht belegt, aber Hinweise auf gravierende Nebenwirkungen

Only available in German

Only available in German

Anwendung soll nur im Rahmen klinischer Studien oder valider Behandlungs-Protokolle stattfinden. Alle Nebenwirkungen sollen gemeldet werden.

Recent information about regulatory flexibility during the corona pandemic can be found here on the website of the BASG.