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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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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
CHMP Meeting Highlights-BASG New Austrian members of the CHMP report on meeting highlights concerning centralised procedures: recommendations for approval, extensions of therapeutic indication, newly published
02/03/2023 International Networking Representatives of BASG in national, European and international committees and working groups: L_A50_Committees_BASG | 692 KB 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
des BASG | 390 KB 02/07/2024 106. Anlage der Geschaeftsordnung des BASG | 270 KB 22/04/2024 105. Anlage der Geschaeftsordnung des BASG | 202 KB 07/03/2024 104. Anlage der Geschäftsordnung des BASG | 240 [...] des BASG | 345 KB 05/05/2023 102. Anlage der Geschäftsordnung des BASG | 341 KB 13/03/2023 101. Anlage der Geschäftsordnung des BASG | 156 KB 20/01/2023 100. Anlage der Geschäftsordnung des BASG | 370 [...] g des BASG | 362 KB 19/07/2022 98. Anlage der Geschäftsordnung des BASG | 162 KB 11/07/2022 97. Anlage der Geschäftsordnung des BASG | 359 KB 05/04/2022 96. Anlage der Geschäftsordnung des BASG | 358 KB
Suggestions and wishes | eSubmission@basg.gv.at | +43 (0) 50 555-36033 eCTD Validation Criteria Validation criteria for the technical validation of eCTDs The BASG / AGES Medizinmarktaufsicht uses the published [...] KB 22/08/2024 AGES e-Validator 24.1 | 97 MB 22/08/2024 feedbacks Suggestions and wishes eSubmission@basg.gv.at Technical Validation Guidance for the technical validation of eCTD, NeeS and VNeeS submissions
shall act on behalf of the BASG during the sovereign execution. Legal basis: Health and Food Safety Act BASG and AGES MEA The Federal Office for Safety in Health Care (BASG) is entrusted with the execution [...] About us BASG - Federal Office for Safety in Health Care / AGES MEA - Austrian Medicines and Medical Devices Agency As of January 2, 2006, the BASG commenced its work as the national authority for medicines [...] effects, their production, transport and storage. The BASG also performs blood and tissue vigilance tasks. AGES has close organizational ties with BASG. It provides the Federal Office with services, personnel
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
the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG) reserves the right to request a readability test if there is doubt that the submitted Package Leaflet [...] the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG) please refer to the FAQ eServices "Marketing Authorisation & Lifecycle Management of Medicines". [...] the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG) and are summarised in the document "Empfohlene Vorgehensweise für stilistische Belange" (‘Stylistic