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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…

Based on a re-evaluation of the safety and efficacy data, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends the withdrawal of the marketing authorization for all bufexamac-containing medicinal products within the EU, as the benefit/risk ratio for these preparations is no longer given.…

AGES PharmMed receives a large number of requests for decentralized procedures (DCP) and mutual recognition procedures (MRP) to act as procedure managing state (RMS). The slot allocation procedure for DCP submissions has been designed to allow for the best possible planning of requests and optimal utilization of reviewer resources. AGES PharmMed…

On March 29, 2010, the delivery of generic drugs containing Clopidogrel, which used the active ingredient of the supplier Glochem Industries Ltd., was stopped for the time being on wholesale level by BASG/AGES PharmMed. It was determined that the production of the active ingredient was not carried out in compliance with GMP (Good Manufacturing…