Official announcements
messages in brief
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06/10/2021
This event aims to inform SMEs and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities.
messages in brief
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06/10/2021
The aim of this event is to help future CTIS users prepare for submitting and evaluating clinical trial applications in CTIS after its go-live on 31 January 2022.
messages in brief
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30/09/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Enforcement
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28/09/2021
Distribution of an unauthorised medicinal product through illegal websites
Recall
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Medicines
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27/09/2021
Recall of batches with nitrosamine levels above the acceptable daily limit.
Recall
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Medicines
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21/09/2021
Recall due to azido contamination above the acceptable limit.
Recall
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Medicines
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21/09/2021
Recall due to azido contamination above the acceptable limit.
messages in brief
Medicines
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20/09/2021
The Product Information has been updated with the new shelf-life for the frozen vial, that has been extended from 6 months to 9 months. The storage conditions remain unchanged (-90 °C to -60 °C).
Safety warnings
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Blood & Tissue
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20/09/2021
The Federal Office for Safety in Health Care has been informed by the ECDC (European Centre for Disease Prevention and Control) that a human WNV infection has been reported for the first time in the Spree-Neiße region in Germany during the current season.