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.
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.
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.
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).
The Federal Office relies on reports from consumers, health care professionals and companies for the continuous re-evaluation of the safety profile of medicinal products and medical devices.
The medicinal products database contains all products authorised in Austria, including up-to-date product information leaflets and the summary of products characteristics.
This is the subpage with information from the BASG directed to health care professionals (physicians, dentists, veterinarians, midwives and pharmacists).