What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
For the RSS feed with daily notification of updates, use the link: RSS feed to "what's new".
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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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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!
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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!
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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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24/06/2020
Die Warnung umfasst Produkte die außerhalb von legalen Apotheken angeboten werden
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29/05/2020
Vorteilhafte Wirkung nicht belegt, aber Hinweise auf gravierende Nebenwirkungen
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24/04/2020
Anwendung soll nur im Rahmen klinischer Studien oder valider Behandlungs-Protokolle stattfinden. Alle Nebenwirkungen sollen gemeldet werden.
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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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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).
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Medicines
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20/04/2020
Central contact points in each federal state survey needs and coordinate distribution