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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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pre-clinic and clinic basg-heve@basg.gv.at Pharmacovigilance basg-v-phv@basg.gv.at Department Biologicals, Preclinical & Statistical Assessment Fee-based scientific advice scientificadvice@basg.gv.at For inquiries [...] Regulatory Affairs RMS procedures rms@basg.gv.at CMS procedures basg-cms@basg.gv.at National Procedures nat@basg.gv.at Other inquiries hotline.euregulatory@basg.gv.at UPC contact point upd-contact@ages
address entries in EMA's organisation management OMS. You can find more details here: https://www.basg.gv.at/marktbeobachtung/amtliche-nachrichten/detail/organisation-management-service-oms-integratio
general cover letter, must be submitted to the BASG via the Common European Submission Portal (CESP). Before or at the same time as the application to the BASG, the application for approval of the clinical [...] competent authority of the Member State in which the clinical trial is to be conducted. In Austria, the BASG is the competent authority for this purpose. Irrespective of this, the application for approval of [...] ion Before the start of each clinical trial, an application for approval must be submitted to the BASG. The documents required for proper submission are listed in the appendix of the application form "
templates for PDF with unlimited access (PDF/UA) The BASG has updated the accessible versions, which are available for download at https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycl [...] information please refer to Accessible patient information leaflet - BASG , resp. FAQ Accessible patient information leaflet - BASG . CMDv - call for early submission and statistics Please find the call [...] SmPC, package leaflet and labelling . For further information please refer to FAQ online services - BASG . Based on the final package leaflet , an accessible PDF document has to be created and also uploaded
ance Union Product Database (UPD) Notification of pet products National Legislation / Information BASG talk NVR
registration office, have I received an error message when I submitted my annual registration via the BASG portal? What do I have to pay attention to when "Submitting a message"? Where can I get the necessary [...] carried out to check whether the technical requirements have been met. Please contact AGES (e-mail: basg-eservices@ages.at) if you have any questions regarding the procedure of the Vet-AB-MengenströmeVO [...] carried out to check whether the technical requirements have been met. Please contact AGES (e-mail: basg-eservices@ages.at) if you have any questions about the procedure of this procedure. AGES will send
adverse drug reactions directly to the BASG. Physicians, pharmacists and other health care professionals are legally obliged to report adverse reactions. https://www.basg.gv.at/en/market-surveillance/repor [...] shortly afterwards ("background incidence"). In Austria, the Federal Office for Safety in Health Care (BASG) records all suspected adverse reactions to medicinal products and vaccines that have occurred in
BASG announcements Since 01.08.2013 BASG authorisations and changes of medicinal products related to the identification are listed on a daily basis under BASG-Verlautbarung. Since 25.06.2015 centrally
BASG approval procedure Since 2013: After the decision has been made, the results of the BASG votes are listed in an electronic release process updated daily. Voting archive 2012-2013 BASG Abstimmungen
Contact For technical questions about online services and eServices, please contact us at basg-eservices@basg.gv.at .