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 (BASG) has been informed by the ECDC (European Center for Disease Prevention and Control) that a human WNV infection has been recorded in Seville, in the region of Andalusia.
The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank European Sperm Bank (DK257572) that a "non-classical adrenogenital syndrome" had been reported in an offspring of the sperm donor 8845 BERRY.
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 25639-TESSER has been diagnosed with 22q11 duplication syndrome.
Up-to-date information from the February 27.03.-30.03.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.
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).