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".
Searched for 2022.
Recall
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Medicines
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08/03/2022
Recall due to nitrosamine contamination above the permitted daily dose
03/03/2022
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messages in brief
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14/02/2022
With the AMG amendment of 14.02.2022, § 21(2) was changed to the effect that the BASG must now be notified four months (instead of the previous two months) in advance of a temporary or permanent discontinuation of the marketing of medicinal products.
Recall
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07/02/2022
sheet for users of genetic resources including checklist | 165 KB 07/02/2022 Leitfaden inkl. Annex I und II | 1 MB 07/02/2022
03/02/2022
Communication (DHPC) / Educational Material (EM) (L_Z100) | 325 KB Available in German only 03/02/2022
messages in brief
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31/01/2022
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
messages in brief
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31/01/2022
On Monday 31st January 2022 at 9:00 a.m. CET, the Clinical Trials Information System (CTIS) has gone live. CTIS is the backbone of the Clinical Trials Regulation that will harmonise the assessment and supervision of clinical trials in the EU and the EEA.
25/01/2022
Diese Gebührenverordnung findet Anwendung auf alle Anbringen, die ab dem 28.01.2022 beim BASG eingegangen sind.
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20/01/2022
Dem Bundesamt für Sicherheit im Gesundheitswesen wurde von der dänischen Behörde mitgeteilt, dass sie von der dänischen Gewebebank European Sperm Bank (DK257572) darüber informiert wurde, dass es in Verbindung mit der Verwendung von Samen des Samenspenders 27012-ROLAND zur Erkrankung eines Kindes an angeborener dilatativer Kardiomyopathie gekommen ist.
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