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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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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
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
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 "
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
Contact For technical questions about online services and eServices, please contact us at basg-eservices@basg.gv.at .
C3%A4ufig-gestellte-Fragen-zum-Thema-Impfungen.html Does BASG provide individual vaccination advice? No. As the official Medicines Agency, BASG can merely provide information about which vaccines MAY be [...] FAQ Vaccines Frequently asked questions about vaccinations - Federal Ministry of Health Does BASG provide individual vaccination advice? Which studies and controls have to be performed before vaccines
datenschutz@basg.gv.at . The legal framework is laid down in the Health and Food Safety Act (GESG), Federal Law Gazette I No. 63/2002 as amended. In fulfilment of its statutory duties, the BASG is entitled [...] to the processing of personal data: a. Legal basis The tasks of the BASG are defined in § 6a GESG. In fulfilling these tasks, the BASG is entitled to process personal data pursuant to § 9 para 7 GESG. In [...] ing provisions authorising the BASG to pass on personal data can be found in the relevant material laws (e.g. Section 80 of the Medicines Act). 4. Data security The BASG provides for technical and org
parties whose activities are regulated by the material laws under the jurisdiction of the BASG. The services of the BASG are available to all applicants and notifiers who are entitled under the material laws [...] Section 82a of the German Medicines Act (AMG), all employees of the BASG and the AGES MEA are obliged to submit annual declarations to the BASG regarding any grounds for bias. The criteria used for the evaluation [...] Safety Act (GESG) with the execution of the tasks of the Federal Office for Safety in Health Care (BASG). Pursuant to § 8 (7) GESG, the acceptance of third party contracts is prohibited for this business
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