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 Italian authorities that in Italy, in addition to the regions already announced, ID WNV NAT testing for donations of blood and blood components has been introduced in Modena (Emilia-Romagna region).
Important information from the Federal Office for Safety in Health Care concerning the suspension of the marketing authorization and the recall of all batches of the veterinary medicinal product "Kexxtone 32.4 g continuous-release intraruminal device for cattle. Monensin"
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).