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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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submitted. At https://eservices.basg.gv.at , authorized users can submit their applications in a straightforward manner. For more information, please contact chargen@basg.gv.at! For eServices, please visit [...] Please submit your applications via the portal at https://eservices.basg.gv.at . If you do not find your product, contact chargen@basg.gv.at or, in urgent cases, use one of the following forms for the first [...] with the Animal Diseases Act. Who must apply for batch release? Companies with autorisation from the BASG to produce, control, sale and distribute Medicinal Products Companies which are approved contract
including evidence. Finally, the BASG prepares the final report. In addition to the original report, it contains the opinion of the inspected party and a final assessment by the BASG of the measures proposed and [...] and implemented. If the proposed measures are not sufficient, the BASG will prescribe appropriate measures. The procedure is completed with receipt of the final inspection report or the specification of [...] an overview of the procedures of inspections of clinical trials carried out or in progress by the BASG according to the Austrian Medicines Act (AMG) or the Austrian Medical Devices Act (MPG). Listed are
Content Content Legal basis of blood safety The role of the Federal Office for Safety in Health Care (BASG) in the context of tissue safety The role of the European Commission Legal basis of blood safety For [...] n on plasma products Plasma Master File The role of the Federal Office for Safety in Health Care (BASG) in the context of tissue safety Contact person of the European Commission (Competent authority for
charge and will also be made available as a recording. BASG fee schedule for clinical studies As of 01 January 2023 , an updated fee tariff of the BASG was put into force. From this date, index-adjusted tariffs [...] products - REG (EU) 536/2014 Overview Clinical trials' transition to new EU system - one year left! BASG fee schedule for clinical studies Information and training material Clinical trials' transition to [...] products was suspended in 2022! The same fees apply as for commercial studies. Please refer to the BASG fee schedule for the current fees. Information and training material Information from the European
amended as stipulated. The change has to be notified to the Federal Office for Safety in Health Care (BASG). For marketing authorisation procedures that are still ongoing, the amended PL will be authorised