As part of its transparency policy, the EMA has made data on adverse reaction reports publicly available at www.adrreports.eu since May 31, 2012. This website provides access to aggregated data on adverse drug reactions submitted by national authorities and marketing authorization holders to the pan-European database EudraVigilance in accordance…

On this occasion, the minister reminded the audience that many countries in Europe are cutting back on health care, and sometimes health care facilities are being dismantled. "It is different in Austria: the federal government has clearly stated that we want to further develop the healthcare system. Therefore, I am particularly pleased that we are…

Around 30 girls between the ages of ten and 16 learned more about the assessment and control of medicines on today's Girl's Day. They were able to actively and passively deal with the challenges of drug control at four stations. The focus was on the high-performance analysis of drugs, pharmaceutical methods and the analysis of plant drugs. At the…

The increasing complexity of the legal materials AMG and MPG, in particular the areas of clinical testing, medical devices in general, in vitro diagnostics, etc., increasingly lead to ambiguities in the implementation of research projects. In order to provide appropriate support, the BASG is offering a "consultation hour" for western Austria from…

We would like to point out that the deadline set in accordance with Section 94c(10) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, for the submission of documents relating to an extension of the marketing authorization will expire in a few weeks. For all medicinal products that have already been renewed at least once…

Methotrexate (MTX) is used to treat severe forms of psoriasis, autoimmune diseases (e.g., rheumatoid arthritis), and various tumor diseases. It is strictly available only on prescription. As a so-called "antimetabolite", the active ingredient methotrexate inhibits the formation of certain building blocks of the DNA of the cell nucleus and thus…

The BASG / AGES Medical Market Inspectorate became aware that pharmaceutical companies were contacted by telephone in the name of AGES, or by persons claiming to be AGES employees, in order to request personal or company-related data. In this regard, we would like to inform you that we do not request personal or company-related data by telephone,…

As early as April 2010, the Federal Office for Safety in Health Care was informed about potential problems with the use of metal-on-metal hip implants. The Federal Office for Safety in Health Care assessed the risk situation for Austrian patients. As early as May 2010, the most important manufacturers operating in Austria as well as the responsible…

The European Medicines Agency (EMA) has published a first tranche of modules of the Good Vigilance Practice (GVP) guide for public comment. In detail, these are the following seven chapters, each covering one of the main aspects of the drug safety system: Module I: Pharmacovigilance systems and their quality systems; Module II: Pharmacovigilance…

The preparations Xenical and alli (active ingredient: orlistat) have been approved throughout Europe since 1998 and 2007, respectively, for weight reduction in adults who are overweight (body mass index BMI > = 28 kg/m2 in conjunction with a slightly hypocaloric, low-fat diet. Measures at EU level The risk of liver reactions associated with the use…