Official announcements
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23/06/2010
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…
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10/06/2010
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…
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02/06/2010
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…
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21/05/2010
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…
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26/04/2010
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…
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31/03/2010
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…
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29/03/2010
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…
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04/03/2010
The update of the general data for Austria was sent to the European Commission on 03.03.2010. The last update was in July 2008. Since the updated document will be published on the Commission's website only in the next few weeks, you will find the…
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01/03/2010
On March 21, 2010, an amendment to the Medical Devices Act (MPG) (Federal Law Gazette I No. 143/2009 of December 30, 2009) will come into force. Changes concern the reporting procedure for clinical trials with medical devices and the reporting…
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17/02/2010
Due to the current supply situation of certain radiopharmaceuticals, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed points out particularities in the use of unapproved medicinal specialties, especially with unapproved…
