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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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Code of Conduct applies to the employees of the Austrian Medicines and Medical Devices Agency 10/05/2022 Strategic objectives 1. Ensuring sustainable and successful positioning on the market and within the
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
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
s. Facts Folder 2023 | 1,014 KB 21/11/2023 Facts Folder 2021 | 587 KB 21/12/2022 Jahresbericht 2018/2019 | 10 MB 15/12/2022 Annual Report 2016/2017 | 2 MB 06/12/2019 Jahresbericht 2015 | 2 MB 10/03/2021
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
Data provision medicine shortages Update March 2022 In order to enable a simple integration of current contents of the „Shortages catalogue“ into external IT systems, two endpoints are provided in a pilot [...] REST-based API retrieval options is already being planned and is expected to be completed from Q2/2022. Release Notes The data file is created daily (between 0:00 and 4:00 am) and made available on the
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
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
RECENT COMMITTEE NEWS MRP/DCP statistics from 2022 . The CMDh has presented its annual statistics on DC/MR procedures for 2022 according to the CTS database. In 2022, Austria as RMS ranked 9 th in finalized [...] variation applications for centrally authorised human medicinal products in October 2022. The scope of the October 2022 go-live will be limited to variation applications of centrally authorised human products [...] for submissions as of 1 st November 2022 , but it can already be used before that date on a voluntary basis. See the recent press release from the CMDh September 2022 meeting for further details. Applicant’s
188 KB 25/01/2018 Formular: PSUR Zyklusänderungen (F_B23) - only available in German | 97 KB 24/11/2022