Official announcements
Safety warnings
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Blood & Tissue
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28/07/2020
The Federal Office for Safety in Health Care was informed by the Italian authority that in the provinces of Milan and Pavia (Lombardy Region), due to the detection of WNV NAT positive mosquito pools, the ID WNV NAT testing for donations of blood and blood components was introduced.
messages in brief
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27/07/2020
We have published updated versions for human accessible Package Leaflets and the QRD template!
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.
Recall
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Medicines
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13/07/2020
Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.
Recall
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Medicines
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13/07/2020
Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.
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!