What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
For the RSS feed with daily notification of updates, use the link: RSS feed to "what's new".
Search narrowed by
the identification number 0198). Confirmation of Accreditation | 258 KB 18/08/2022 Scope of Accreditation | 5 MB 18/08/2022 The pharmaceutical OMCL at 1220 Vienna, Spargelfeldstrasse 191 voluntarily renounced [...] continues to further develop an effective quality management system. Certificate (ISO 9001) | 857 KB 27/09/2022 Accreditation in accordance with ISO 17025 The laboratory activities of the Official Medicines Control [...] the OMCL-Network . EDQM Audit Attestation 2021 | 84 KB 15/12/2021 Scope of Assessment | 179 KB 05/01/2022 BEMA (Benchmarking of European Medicines Agencies) The Heads of Medicines Agencies (HMA) have established
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on the obligation to report non-interventional studies was repealed on 07.10.2022 by BGBl II No. 374/2022 (RIS - BGBLA_2022_II_374 - Bundesgesetzblatt authentisch ab 2004 (bka.gv.at) .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