What's new
Information from the previous month appears monthly in the newsletter “What'sNew” (link to registration page).
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Safety warnings
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Blood & Tissue
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10/07/2026
The Federal Office for Health Security (BASG) has been informed by the Italian authorities that, in addition to the provinces already announced, ID WNV NAT testing for donations of blood and blood components has been introduced in Milan, Lodi, Monza and Brianza (Lombardy region), as well as in the provinces of Venice and Vicenza (Veneto region).
10/07/2026
0726_Register bewilligter AM Betriebe Österreich.xlsx BASG / AGES Institut Überwachung Abteilung GMDP Lizenznum mer Betriebsstandort Straße PLZ Ort Umfang der Bewilligung gemäß § 63 AMG 481867 A. Mena
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10/07/2026
Dem Bundesamt für Sicherheit im Gesundheitswesen (BASG) wurde von der italienischen Behörde mitgeteilt, dass in Italien, zusätzlich zu den bereits bekannt gegebenen Provinzen, in Mailand, Lodi, Monza und Brianza
(Region Lombardei), sowie in den Provinzen Venedig und Vicena (Region Venetien) die ID WNV NAT Testung für Spenden von Blut und Blutkomponenten eingeführt wurde.
Referenced at:
10/07/2026
0726_Bearbeitungsstand.xlsx BASG / AGES Institut Überwachung Abteilung GMDP und BTVI Verfahrens- nummer Lizenz- nummer Bewilligungs-inhaber Betriebsstandort Straße PLZ Ort Clock stop Auftrag Zuteilung
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10/07/2026
0726_Register Arzneimittelvermittler.xlsx BASG / AGES Institut Überwachung Abteilung GMDP Lizenznummer Betriebsstandort Straße PLZ Ort 484516 AGILIS Trading GmbH Kärntner Str. 26/3 1010 Wien 484493 Am
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CHMP Monthly News
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09/07/2026
Up-to-date information from the 22.06.-25.06.2026 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
CHMP Monthly News
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09/07/2026
Up-to-date information from the 18.05.-21.05.2026 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
Safety warnings
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Medical devices
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08/07/2026
The Federal Office for Health Security (BASG) has issued a warning regarding the unauthorised distribution by third parties of batches 1725204004 and 1725069002 of the medical device “Dexcom G7 Sensor”.
X-ray contrast agents New
PRAC signal recommendation
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08/07/2026
Risk for fixed drug eruption. Further information and amendments to the product information can be found on the EMA website.
Valproate and related substances New
PRAC signal recommendation
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08/07/2026
Risk for neurodevelopmental disorders with paternal exposure. Further information and amendments to the product information can be found on the EMA website.