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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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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
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 KB 12/10/2023 103. Anlage der Geschäftsordnung des BASG | 345 [...] 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 KB 21/11/2022 99. Anlage der Geschäftsordnung des BASG | 362 [...] g 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 23/02/2022 95. Anlage der Geschäftsordnung des BASG | 357 KB
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
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
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.