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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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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
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
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
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
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
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