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02/03/2023 International Networking New Representatives of BASG in national, European and international committees and working groups: L_A50_Committees_BASG | 692 KB New 29/08/2024 [...] (pharmacovigilance) is ensured by the network of national agencies. In Austria, this task is performed by BASG / AGES Medizinmarktaufsicht. The CHMP monitors at European level the reports on adverse reaction reports [...] relating to new legislation and opinions on draft legislation. Joint Action EU4H-2021-JA-11 AGES/BASG coordinates EU4H 11 Joint Action to strengthen EU/EEA NCAs - Medicines Inspectorates EU4H11 (Joint
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documents have been duly received. The BASG guidance is currently under revision and till then also include this requirement. Electronic Submission Form of the BASG The electronic registration form is mandatory [...] on of receipt will be sent from the BASG system PHAROS to the applicant. Confirmations of receipt from the e-mail system do not apply here. From this date the BASG will confirm that the notification is [...] investigations with medical devices Regulation on electronic submission Electronic Submission Form of the BASG General requirements for applications (technical validation) Clinical investigations according to