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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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188 KB 25/01/2018 Formular: PSUR Zyklusänderungen (F_B23) - only available in German | 97 KB 24/11/2022
requires the following changes to the EudraGMDP database, which will be implemented from 28 January 2022: Integration of EudraGMDP into the Organization Management Service (OMS) of EMA. Extension of the [...] n (API-Reg) The most important change is the integration of EudraGMDP into OMS. As of January 28, 2022, national authorities will no longer be able to enter organizational data (organization or facility [...] manufacturing or wholesale, GMDP certificates,) the OMS data will also be transferred. As of January 28, 2022, the national authorities can only make entries in EudraGMDP or create documents in this system if
l 25/01/2018 Formular: PSUR Zyklusänderungen (F_B23) | 97 KB Antrag auf PSUR-Zyklusänderung 24/11/2022 EURD list The European Medicines Agency has published the list of European Union (EU) reference dates
als Anfangsbestand der gemeldete Endbestand aus der Nachweisung 2022 heranzuziehen. Jegliche Abweichungen vom gemeldeten Endbestand 2022 zu ihrem tatsächlichen Anfangsbestand 2023 (Warenwirtschaftssystem [...] aufgenommen. Formular: Suchtmittel_Nachweisungsformulare_Stammdaten_Aufnahme (F_I313) | 49 KB 23/02/2022 Suchtmittelverluste - in German only Das Formular zur unverzüglichen Meldung von Suchtmittelverlusten
21/11/2022 99. Anlage der Geschäftsordnung 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 [...] Anlage der Geschäftsordnung des BASG | 358 KB 23/02/2022 95. Anlage der Geschäftsordnung des BASG | 357 KB 19/01/2022 94. Anlage der Geschäftsordnung des BASG | 361 KB 30/04/2021 93. Anlage der Geschäftsordnung
Medicines Act (AMG) if they meet the requirements of Section 59a para. 2 and 3 AMG. From January 28, 2022, the dispensing of veterinary medicinal products by means of distance selling is permitted in accordance
.xsd | 6 KB 13/09/2022 Meldung_Vertrieb-1_0.xsd | 4 KB 30/03/2023 Example messages Meldung_Vertrieb_valide-1_0.xml | 892 B 30/03/2023 Meldung_Abgabe_valide-1_0.xml | 2 KB 13/09/2022 Freiwillige_Detail [...] meldung_valide-1_0.xml | 1 KB 13/09/2022 Abgabe-Leermeldung_valide-1_0.xml | 901 B 14/02/2024 Anwendungs-Leermeldung_valide-1_0.xml | 891 B 14/02/2024 Catalogue Information on catalogues can be found here
and notifications (Electronic Ordinance on Submissions 2011 - EEVO 2011) version 30.07.2022 | 58 KB 01/08/2022 Ordinance of the BASG on the electronic transmission of applications and notifications ( [...] medical devices (German only) Ordinance of the BASG on fees for medical devices, version 30.07.2022 | 75 KB 01/08/2022 BASG on official badge (German only) BASG communication on official badges, version 30.01
2021 | 9 MB Only available in German 20/12/2022 Report on the activities of the Austrian tissue establishments 2020 | 7 MB Only available in German 01/02/2022 Summary of the 2020 annual reporting of serious [...] (0)50 555-36408 Emergency Phone Number (24-Hours): +43 (0)664 831 28 43 Annual reports From 01.01.2022, every tissue bank or procurement center is obliged (according to § 4 as well as § 6 Tissue Vigilance [...] reporting is only available in German.) Annual report on activities of tissue establishments From 01.01.2022, tissue banks are obliged (according to § 16 (6) Tissue Safety Act) to submit an annual report on