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Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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Safety warnings
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messages in brief
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01/07/2011
Ketoprofen-containing proprietary medicinal products are approved for the local symptomatic therapy of pain conditions, mainly in the field of traumatology and rheumatology. Due to reports of light-allergic reactions, the risk-benefit balance of…
messages in brief
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03/05/2011
On May 3, 2011, the Ordinance of the Federal Office for Safety in Health Care on the Electronic Transmission of Applications and Notifications (Electronic Submission Ordinance 2011 - EEVO 2011) was published in the Official Gazette of the Federal…
messages in brief
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02/05/2011
Hip joint endoprostheses are medical devices of the highest risk class (class 3). These medical devices must undergo a development program with clinical studies. If the benefit-risk profile is appropriate, the device is certified by a notified body…
messages in brief
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26/04/2011
The background to the recent discussions is not a 'new' document from the European Commission, but the 2004 Directive 2004/24 EC, which defines traditional herbal medicinal products and sets the regulatory framework for them across the EU. This…
messages in brief
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08/03/2011
Prevenar (active ingredient: pneumococcal polysaccharides of serotype 4, 6B, 9V, 14, 18C, 19F and 23F, conjugated to CRM197 carrier protein, adsorbed) has been licensed since 2001 under the centralized procedure in all EU member states for children…
messages in brief
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03/03/2011
[Translate to english:] EudraCT - Umstellung auf Version 8
messages in brief
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01/12/2010
As of 01.12.2010, the agreement between the Republic of Austria and the Government of the Principality of Liechtenstein concerning the automatic recognition in Liechtenstein of human and veterinary medicinal products authorized or registered in…
messages in brief
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27/09/2010
BASG/AGES PharmMed informs about the internal changeover of the E2B transmission of individual case reports, which was previously done via WebTrader, to gateway operation. The changeover will take place in October. For notifiers who have already…
messages in brief
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01/09/2010
All eServices offered by BASG / AGES PharmMed will be available via this platform in the future. Currently, the following services can be accessed via the eServices navigation point: Non-interventional studies (NIS) : Public register of all NIS…
messages in brief
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20/08/2010
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…