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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…
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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…
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02/05/2011
Before using the web portal for the first time, registration of the organization is required. In the process, the authorization within the meaning of §§ 4 and 13 AWEG is verified. After successful registration, the applicant receives a user name and…
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29/04/2011
On possible radioactivity
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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…
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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…
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03/03/2011
[Translate to english:] EudraCT - Umstellung auf Version 8
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02/02/2011
AGES PharmMed is receiving a high number of requests to act as Reference Member State for the Mutual Recognition and Decentralised Procedure. The routine of allocating time slots for DC procedures allows better scheduling of applications and…
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29/12/2010
At the end of 2010, the following deadlines will expire according to the Medicines Act BGBl Nr 185/1983 as amended: Inclusion of doping warning until 31.12.2010 All medicinal products concerned must contain the doping warning by 31.12.2010 (according…