Official announcements
Safety warnings
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Blood & Tissue
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12/10/2020
The Federal Office for Public Health was informed by the Italian authority that a confirmed human infection with WNV has been recorded in the province of Vicenza (Veneto).
Safety warnings
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Blood & Tissue
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12/10/2020
The Federal Office for Safety in Health Care has been informed by the ECDC that confirmed human cases of WNV infection have occurred in Germany in Anhalt-Bitterfeld and Halle (Saale).
messages in brief
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05/10/2020
The new position paper focuses on managing supply bottlenecks by improving processes and transparency and serves to clarify the role of players in the distribution chain.
Enforcement
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30/09/2020
Supposed natural product turns out to be a counterfeit
Recall
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Medicines
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30/09/2020
Precautionary recall because the efficacy may be reduced.
Recall
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Medicines
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30/09/2020
Recall of one batch of Adolorin Ibuforte 400 mg Dragees due to reduced release of the active substance.
messages in brief
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29/09/2020
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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29/09/2020
In the following cases Marketing Authorisation Holders/Holders of a Registration need to act, these tasks have to be finalised until 31.12.2020.
messages in brief
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29/09/2020
Please note that all package leaflets have to be published in an accessible format on Arzneispezialitätenregister at latest at 31.12.2020.
Safety warnings
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Blood & Tissue
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28/09/2020
The Federal Office for Safety in Health Care was informed by the ECDC that there have been confirmed human cases of WNV infection in Barnim, Ostprignitz-Ruppin and Saalekreis in Germany.