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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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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
188 KB 25/01/2018 Formular: PSUR Zyklusänderungen (F_B23) - only available in German | 97 KB 24/11/2022
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
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
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
Form: Parallelimport (F_Z10) | 67 KB Antrag auf Genehmigung für den Vertrieb im Parallelimport 05/09/2022
on the obligation to report non-interventional studies was repealed on 07.10.2022 by BGBl II No. 374/2022 (RIS - BGBLA_2022_II_374 - Bundesgesetzblatt authentisch ab 2004 (bka.gv.at) . A reporting obligation [...] Guideline for differentiation clinical study - non-interventional study - other study | 280 KB 11/10/2022
Version 9.0 (04/2022) 24/05/2022 QRD-Template_veterinaer_Version_2022.dotx | 44 KB Accessible QRD template for medicinal products for veterinary use, Version 9.0 (202210/2021) 24/05/2022 Previous version [...] Gebrauchsinformation veterinaer Version 2022 | 33 KB Accessible Template: German Package leaflet for medicinal products for veterinary use, Version 9.0 (202210/2021) 24/05/2022 QRD combined label-leaflet veterinaer [...] the current version of the EMA QRD Templates in July 2020 and slightly revised. Furthermore, in May 2022, the BASG templates for veterinary medicinal products were revised in accordance with the new QRD
together with the complete protocol and enough sample material for testing at the OMCL. From September 2022, there will be a new portal through which batch release applications can be submitted. At https:/
2001/20/EC. The reduction of tariffs for academic clinical trials of medicinal products was suspended in 2022! The same fees apply as for commercial studies. Please refer to the BASG fee schedule for the current