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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on the obligation to report non-interventional studies was repealed on 07.10.2022 by BGBl II No. 374/2022 (RIS - BGBLA_2022_II_374 - Bundesgesetzblatt authentisch ab 2004 (bka.gv.at) .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
Registry 2013 Ordinance on reporting obligation for Non Interventional Studies - NIS 2010 - cancelled in 2022 Ordinance on herd-specific veterinary vaccines 2010 Ordinance on labelling of medicinal products 2008
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
Regulations", "CTR") are contained in the Austrian Medicines Act (AMG), Federal Law Gazette I No. 8/2022 . The competent authority in terms of the CTR is the Federal Office for Safety in Health Care (BASG)
NVR BASG offered a BASG talk (BASG-Gespräch) on the New Veterinary Medicines Regulation on 8 Nov. 2022, and the programme and slides have been filed here: https://akademie.ages.at/basg-gespraech_nvr__
changes Gebührentarif Verordnung Nr.2-2022 | 388 KB 16/12/2022 Gebührentarif Verordnung Nr.1-2022 | 65 KB 05/08/2022 Gebührentarif Verordnung Nr.3-2021 | 355 KB 25/01/2022 Gebührentarif Verordnung Nr.2-2021