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Creating Accessible Package Leaflets

messages in brief | 27/07/2020
We have published updated versions for human accessible Package Leaflets and the QRD template!
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BREXIT Transition period

messages in brief | 09/07/2020
The EC has published a useful summary of applicable EU rules after the end of the transition period. You can find the link here on the website of the BASG.
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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
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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
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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
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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
COVID-19: Nebenwirkungsmeldungen Read more
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