The Medicinal Products Import Act 2010, BGBl I 79/2010, came into force on 19.08.2010. Compilation of the scenarios possible according to the law and the forms to be used: AWEG 2010 scenarios import certificates.pdf AWEG 2010 scenarios marketability certificates.pdf AWEG 2010 scenarios movement certificates.pdf Note: Pursuant to Section 26(1) and…

On 18.08.2010, the Medicinal Products Import Act 2010 was published in the Federal Law Gazette, Federal Law Gazette I No. 79/2010 and comes into force on 19.08.2010. The primary objective of the Medicinal Products Import Act is to protect the health of patients and consumers by ensuring safe, high-quality and effective medicinal products. This goal…

The Federal Office for Safety in Health Care (BASG) publishes the following statement on "Calcium Supplementation and Myocardial Infarction Risk." It refers to a meta-analysis on the use of calcium as monotherapy for osteoporosis published in the British Medical Journal on July 29, 2010. (Bolland MJ. BMJ 2010;341:c3691…

Further information: Download guide

Persons who have had a stay in the Netherlands are to be excluded from donation for a period of 6 weeks.

Children's health depends to a large extent on the availability of appropriate medicines. Half of the medicines used to treat 100 million children and adolescents in the EU have not been adequately tested and approved for them. Rather, medicines are often used that have been tested almost exclusively on adults. However, the use of medicines that…

In Federal Law Gazette II No. 180/2010, the Federal Minister of Health made use of the power to issue an ordinance pursuant to Section 48 (3) AMG and issued the Ordinance on the Conduct of Non-interventional Studies. This ordinance stipulates that every non-interventional study started after 01.09.2010 must be reported electronically by the…

The Federal Office for Safety in Health Care (BASG) / AGES PharmMed provides information on holders and carrier arms. Wall mountsA user in Austria was injured after an image intensifier mounted with a height-adjustable bracket fell off the wall. The cause of the wall mount breakage was lack of maintenance of the lead screw assembly. Backlash of the…

According to § 68 of the Medical Devices Act (MPG), Federal Law Gazette No. 657/1996, last amended by Federal Law Gazette I No. 143/2009, the Federal Office for Safety in Health Care (BASG) is responsible, among other things, for monitoring the operation of medical devices in accordance with the Medical Device Operator Ordinance, Federal Law…

On March 17, 2010, the marketing authorization holder (GlaxoSmithKline Biologicals, GSK) informed the European Medicines Agency (EMA) that the oral vaccine Rotarix is contaminated with DNA of the porcine circovirus (PCV). As an immediate measure, GSK Austria together with BASG/AGES PharmMed has decided to stop the delivery of the Rotarix vaccine as…