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).
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Safety warnings
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Blood & Tissue
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20/07/2020
The Federal Office for Safety in Health Care was informed by the Italian authority that in the provinces of Lodi, Mantova, Brescia (Region of Lombardy) and in the province of Piacenza (Region of Emilia-Romagna), due to the detection of WNV NAT positive mosquito pools, the ID WNV NAT testing was introduced for donations of blood and blood components.
messages in brief
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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.
messages in brief
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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.
messages in brief
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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!
messages in brief
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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!
messages in brief
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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
messages in brief
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24/06/2020
Die Warnung umfasst Produkte die außerhalb von legalen Apotheken angeboten werden
messages in brief
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29/05/2020
Vorteilhafte Wirkung nicht belegt, aber Hinweise auf gravierende Nebenwirkungen
messages in brief
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24/04/2020
Anwendung soll nur im Rahmen klinischer Studien oder valider Behandlungs-Protokolle stattfinden. Alle Nebenwirkungen sollen gemeldet werden.
messages in brief
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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.