In order to achieve the highest possible level of health protection, very high quality requirements are placed on the manufacture of medicinal products. As a result, only drugs whose quality, efficacy and safety are guaranteed are released for distribution. This level of quality must be maintained throughout the entire distribution network, which…

Unless marketing authorization holders have made use of the legal provision (Section 94 c (10) of the Austrian Medicines Act) and submitted the required renewal documents for a specific medicinal product to AGES Medizinmarktaufsicht by June 30, 2012, this product can only be marketed until December 31, 2012. As of January 2013, these products are…

The BMG, BMI, BMF and BASG participated in this year's action week. The operation took place this year from 25.09. to 02.10.2012. In total, more than 100 countries worldwide participated in the organized action. The aim was to simultaneously and in a coordinated manner access illegal websites through which counterfeit medicines are distributed and…

The active ingredient desmopressin (contained in various preparations) is approved for the treatment of primary enuresis nocturna, for the treatment of vasopressin-sensitive central diabetes insipidus, and for the treatment of nocturia associated with nocturnal polyuria in adults. The German Federal Office for Safety in Health Care recalls that the…

Ukrain is a medicinal product made from celandine extracts produced by the pharmaceutical company Nowicky Pharma. The drug was advertised in the EU as an alternative cancer treatment without a valid marketing authorization. In Austria, Nowicky Pharma was prohibited from importing, manufacturing and marketing Ukrain by official notice. On September…

In accordance with Section 1 (3b) of the Austrian Medicines Act, Federal Law Gazette No. 185/1983, as amended, the following official demarcation has been made in response to questions submitted to the Federal Office for Safety in Health Care with regard to the demarcation of live animals as medicinal products. Basic information on the definition…

SOKO Temp II

The following innovations are planned throughout Europe: Risk and risk managementAll medicinal products carry known and unknown risks at the time of their authorization. The previous version of Regulation 726/2004 already takes this knowledge into account by stipulating the mandatory submission of risk management plans (RMPs). The new legislation…

The occurrence of venous thromboembolic events (VTE) is a rare but long-known adverse effect of combined oral contraceptives (COCs), which is explicitly mentioned in the technical and instructions for use of the preparations. Recent studies have shown that the risk associated with drospirenone-containing preparations is significantly higher than…

Anapen (active ingredient: epinephrine) has been approved for the treatment of a state of shock (anaphylactic emergency) in some European member states, including Austria, since 2005. Recently, during the further development of the product, a quality defect was discovered, according to which the epinephrine solution is not or not sufficiently…