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under the registration number 09282/0. By granting this certification, Quality Austria confirms that BASG and the Austrian Medicines and Medical Devices Agency operate in accordance with and continues to
scope of the authorisation indicated is based on the classification chosen in § 67 (2). Even if the BASG makes every effort to publish accurate and up-to-date data, no guarantee is given for its completeness
of pharmaceutical retailers The register provides an overview of the notifications received by the BASG from pharmaceutical intermediaries pursuant to Section 71a of the Medicines Act. The list is in a
European Network New
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
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