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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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COVID-19 vaccines In the course of the vaccination campaigns from December 2020 to mid-2023, the BASG provided the current, German-language Summary of Product Characteristics for centrally approved COVID-19 [...] Additionally to its long-standing experience with the testing of plasma products, the Austrian OMCL of BASG/AGES specialised in recent years on the testing of vaccines.
fees valid on the date of application at BASG after 01.06.2024. 28/05/2024 Archive of Fees Fees 01.01.2024 | 326 KB The fees valid on the date of application at BASG after 01.01.2024. 19/12/2023 Fees 01.01 [...] fees valid on the date of application at BASG after 01.01.2023. 16/12/2022 Gebührentarif 15.08.2022 | 560 KB The fees valid on the date of application at BASG after 15.08.2022. 05/08/2022 Gebührentarif [...] fees valid on the date of application at BASG after 28.01.2022. 25/01/2022 Gebührentarif 01.01.2022 | 331 KB The fees valid on the date of application at BASG after 01.01.2022. 20/12/2021 Gebührentarif
technical innovations (updated catalogue values, updated diagrams, etc.), please contact us at: basg-eservices@basg.gv.at A description of all steps, from the registration to the delivery of your file can be [...] subscribe to our distribution list in order to receive updates on new developments. Please contact us at basg-eservices@ages.at . From March19, 2024, zero reports can be carried out as a collective report via
FAQ online Service Guide to setting up and using two-factor authentication for AGES/BASG eServices (L_A192) | 450 KB 09/07/2024 Guidance notes: for the registration of companies/organisations (L_M49) |
Austrian Medicines Act or § 42 Veterinary Medicinal Products Act Further inquiry note am-qualitaetsmangel@basg.gv.at Fax: +43 (0)50 555- 36408 Address for sending defect samples If you wish to send a defective [...] notification, please use the following laboratory address: Bundesamt für Sicherheit im Gesundheitswesen (BASG) Institut Begutachtung & Analytik / Abteilung CPAA Spargelfeldstrasse 191, 1220 Wien 24H number Please
AT). The BASG has to decide within 45 days after receipt of an application. After completion of the assessment, a corresponding decision will be issued. Please address any questions to qrd@basg.gv.at . [...] contact inspektionen@basg.gv.at . Downloads Guideline Exemptions AMG (L_Z173) | 328 KB 29/05/2024 Form Exemption Request §16/17 AMG (F_Z90) | 47 KB 29/05/2024 Further inquiry note qrd@basg.gv.at [...] Medicinal Product Index According to Art 27 AMG the Austrian Medicinal Product Index is published by BASG (Federal Office for Safety in Health Care) where defined data of all authorised and registered medicinal
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
should be made in writing and submitted to the address of BASG, Traisengasse 5 in 1200 Vienna, or by e-mail to the address recht@basg.gv.at . The BASG can then either issue a preliminary decision on the complaint [...] 8/2022 . The competent authority in terms of the CTR is the Federal Office for Safety in Health Care (BASG). Ethics Committees acting under the CTR are organised in a national platform and published on the [...] Committee for the Province of Salzburg the Ethics Committee of the Medical University of Vienna The BASG and the platform of Ethics Committees will define the details of their cooperation in an agreement
Tasks and Activities Tasks of BASG according to GESG Activities of BASG Tasks of BASG according to GESG Pursuant to Gesundheits- und Ernährungssicherheitsgesetz ( GESG ) § 6a. (1) The Federal Office for [...] Safety in Health Care gives scientific advice on the development of medicinal products. Activities of BASG Scientific Advice Admission of Clinical Trials Marketing Authorisation and Lifecycle Management of [...] Market Surveillance und Vigilance of Medical Devices Haemovigilance and Tissuevigilance Form: Process BASG (L A120) | 154 KB 20/03/2020
02/03/2023 International Networking Representatives of BASG in national, European and international committees and working groups: L_A50_Committees_BASG | 182 KB 04/03/2024 [...] (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