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24/02/2012
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…
Safety warnings
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17/02/2012
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…
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06/12/2011
This ordinance serves to implement the power to issue ordinances under Section 12a(2) of the Health and Food Safety Act. It regulates the detailed modalities of the levy, the parties obliged to pay the levy, details of the collection procedure and…
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30/11/2011
The illegally sold and used drug Ukrain, which is advertised as a remedy against cancer, may not be manufactured and sold in Austria for the protection of patients. In addition, individual importation into Austria was prohibited by notice and use…
Safety warnings
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04/11/2011
The Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen) has announced that propofol must not be used in children aged 16 years and younger for sedation in the context of intensive care. This is not a product…
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17/10/2011
On Oct. 11, 2011, the European Commission published revised proposals to amend Regulation (EC) No. 726/2004 and to amend Directive 2001/83/EC. The content of these proposals is to clarify the form in which companies may inform the public about…
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29/09/2011
The BMF, BMI, BMG and BASG participated in this year's action week. The operation took place this year from 20.09. to 29.09.2011. A total of 84 countries participated in the organized action. The aim was to simultaneously and in a coordinated manner…
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28/09/2011
The World Health Organization (WHO) has recognized the EU Clinical Trials Register (CTR) as the primary registry for the International Clinical Trials Registry Platform (ICTRP), a web-based portal that contains information from a number of clinical…
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27/09/2011
Commission Regulation (EC) No. 1234/2008 of Nov. 24, 2008, concerning the examination of variations to the terms of marketing authorizations for medicinal products for human use and veterinary medicinal products (Variation-Regulation), governs…
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27/09/2011
Since 01.09.2011 the new harmonized validation criteria are in force. From now on, the validation of dossiers includes the following criteria: Pass/Fail (P/F) and Best Practice (BP). A dossier is considered valid if all Pass/Fail criteria have been…