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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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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
the current fee regulation and the submission regulation: Fee Regulation of BASG Electronic Submission Regulation 2011 of BASG (EEVO 2011) Laws and regulations Medicinal Products Act (AMG) Regulation on [...] Legal basis Legal basis for the Austrian Federal Office for Safety in Health Care (BASG) National legal bases are only available in German. Federal law establishing the Austrian Agency for Health and Food
neuer Präparate steht zum Download bereit. Nach Einlangen des ausgefüllten Formulars auf suchtmittel@basg.gv.at werden die Angaben geprüft und in den Stammdatensatz der Nachweisungsformulare aufgenommen. [...] bis spätestens 31.01.2024 , gemäß den im Handbuch beschriebenen Vorgaben, per E-Mail an suchtmittel@basg.gv.at (bzw. alternativ über das Eudralink-System) durchzuführen.
After positive feedback from BASG, the required quantity must be stockpiled immediately, but no later than 21 April 2025. A temporary reduction of stock must be reported to BASG immediately via the eServices [...] to enable BASG to assess the issue has to be notified. Temporary reduction of stock resulting from the usual circumstances of a rolling warehouse system are not subject to reporting. The BASG is currently [...] notified in writing via the eServices portal by the Austrian Federal Office for Safety in Health Care (BASG) that a stockpiling demand notification must be submitted for the medicinal procuts listed in the
Federal Office for Safety in Health Care (BASG) by e-mail to am-qualitaetsmangel@basg.gv.at and basg-v-phv@basg.gv.at . Technical questions on the notification: basg-eservices@ages.at [...] placed on the Austrian market if they are notified to the Federal Office for Safety in Health Care (BASG) no later than three months after they have been placed on the market. The first notification should [...] quarter, please fill in the fields provided in the Excel-form available under the following Formular: BASG - TForms . The completed Excel-form should be named with the corresponding year and quarter (e.g.
for approval of the clinical trial is submitted to the Federal Office for Safety in Health Care (BASG) (see § 31 Medicinal Products Act). The BMSGPK decides within 90 days of receipt of all necessary [...] documents on GMOs, which can be found on the website of the European Commission . Decision by the BASG July 1, 2024 The Federal Office for Safety in Health Care decides on the clinical trials with GMOs
holders of estragole-containing medicinal products are requested to consider the publication on the BASG website and, if necessary, to take appropriate measures. Request form template for MRP/RUP. The CMDh [...] of the request form for MRP/RUPs. The updated template can be found on the CMDh website and on the BASG website . Data requirements for marketing authorisation applications in MRP/DCPs. The CMDh has updated [...] the respective procedural steps and will be published on the CMDh website under this link . On the BASG website you will find information on the requirements for day 0 repeat use procedures with Austria
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
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) |