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The Federal Office for Safety in Health Care (BASG) warns of a potential contamination of the non-sterile ultrasound gel “AquaUltra Clear” from the manufacturer Ultragel Medical Kft. According to the manufacturer, the affected batches can be identified by the LOT numbers 2024-4 to 2024-10.

Environmental Risk Assessment - ERA New ERA human ERA veterinary

1224_Register bewilligter AM Betriebe Österreich.xlsx BASG / AGES Institut Überwachung Abteilung GMDP Lizenznummer Betriebsstandort Straße PLZ Ort Umfang der Bewilligung gemäß § 63 AMG 481867 A. Menar

Referenced at:

• Pharmaceutical companies

1224_Register Arzneimittelvermittler.xlsx BASG / AGES Institut Überwachung Abteilung GMDP Lizenznummer Betriebsstandort Straße PLZ Ort 484493 Amarin Switzerland GmbH - Zweigniederlassung Teinfaltstraß

Referenced at:

• Register of retailers

1224_Bearbeitungsstand.xlsx BASG / AGES Institut Überwachung Abteilung GMDP und BTVI Verfahrens- nummer Lizenz- nummer Bewilligungsinhaber Betriebsstandort Straße PLZ Ort Clock stop Auftrag Zuteilung

Referenced at:

• GMP/ GDP

Guidance notes for the notification of national stockpiling Guidance notes for the notification of national stockpiling L_INS_VIE_EVEQ_I285_01 Valid from: 10.12.2024 1/13 Guidance notes for the notifi

Referenced at:

• National stockpiling
• FAQ online Service

ERA human New 1. What legal requirements form the basis for the Environmental Risk Assessment (ERA)? 2. Why is the conduct of an ERA necessary? 3. How is the ERA process structured? 4. For which types

FAQ - reportable qualified persons Which key personnel are companies required to report immediately? a. Companies which place medicinal products on the market (wholesalers)with an operating licence pu

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 8558/Edward has been diagnosed with type 2 diabetes (DM2). The donor/gametes have been permanently blocked.