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Creating Accessible Package Leaflets

messages in brief | 01/07/2020
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.
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Save the Date: BASG-dialogue “Meet the Case Manager”

messages in brief | 30/06/2020
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!
Save the Date: BASG-dialogue “Meet the Case Manager” Read more
News

The „RMS NEWS“ are back!

messages in brief | 30/06/2020
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!
The „RMS NEWS“ are back! Read more
News

Erste COVID-19-Behandlung für EU-Zulassung empfohlen

messages in brief | 25/06/2020
Bedingte Zulassung für Wirkstoff Remdesivir, für Erwachsene und Jugendliche ab 12 Jahren mit COVID-19 Lungenentzündung die Sauerstoff benötigen, empfohlen
Erste COVID-19-Behandlung für EU-Zulassung empfohlen Read more
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COVID-19: Erinnerung an Risiken von Chloroquin und Hydroxychloroquin

messages in brief | 29/05/2020
Vorteilhafte Wirkung nicht belegt, aber Hinweise auf gravierende Nebenwirkungen
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COVID-19: Nebenwirkungsmeldungen

messages in brief | 30/04/2020
Only available in German
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COVID-19: Warnung vor Risiko schwerwiegender Nebenwirkungen von Chloroquin und Hydroxychloroquin

messages in brief | 24/04/2020
Anwendung soll nur im Rahmen klinischer Studien oder valider Behandlungs-Protokolle stattfinden. Alle Nebenwirkungen sollen gemeldet werden.
COVID-19: Warnung vor Risiko schwerwiegender Nebenwirkungen von Chloroquin und Hydroxychloroquin Read more
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COVID-19: Regulatory flexibility

messages in brief | 22/04/2020
Recent information about regulatory flexibility during the corona pandemic can be found here on the website of the BASG.
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EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2020/2021

messages in brief | 22/04/2020
The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2020/2021 (published 1 April 2020).
EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2020/2021 Read more
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