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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
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) * The national legal bases are only available in German Federal law establishing the Austrian Agency for Health
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
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
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
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.
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