Official announcements
Enforcement
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05/04/2024
Das BASG warns against the product "Prostapax Forte", because it is categorised as an illegal medicinal product (medicinal product by presentation) due to its claims in the advertising brochure.
Recall
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Medicines
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04/04/2024
Recall due to a possible incorrect closure of the crimp caps
messages in brief
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31/03/2024
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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25/03/2024
All ongoing clinical trials need to be converted to Clinical Trials Information System ("CTIS") in accordance with Regulation (EU) 536/2014 ("CTR") by January 31, 2025. This date marks the end of a three-year transition period that began when the CTR came into force in the EU. Clinical trials that are not converted by the sponsor in time lose their legal basis and will have to be terminated by the National authority.
Safety warnings
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Blood & Tissue
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22/03/2024
The Federal Office for Safety in Health Care has been informed by the Italian authorities that ID WNV NAT testing for donations of blood and blood components has been introduced in the province of Cosenza (Calabria region) due to a horse testing positive for WNV NAT.
Throughout Italy, donors who have spent at least one night in the specified region are excluded from donating for 28 days.
messages in brief
Medicines
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15/03/2024
The committee on herbal medicinal products (HMPC) of the European Medicines Agency (EMA) published the revised Public Statement on the use of herbal medicinal products1 containing estragole.
Recall
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Medicines
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15/03/2024
Recall of a batch due to visible crystalline particles
Safety warnings
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Blood & Tissue
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14/03/2024
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 one offspring of donor 8212 WITTE has been diagnosed with autosomal recessive hearing loss 77 (DFNB77).
Recall
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Veterinary Medicines
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08/03/2024
Recall due to possible non-sterility
Recall
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Medicines
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08/03/2024
Recall due to exceeding the limit value of the parameter "known impurities"