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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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continues to further develop an effective quality management system. Certificate (ISO 9001) | 857 KB 27/09/2022 Accreditation in accordance with ISO 17025 New The laboratory activities of the Official Medicines [...] service (search for the identification number 0198). Confirmation of Accreditation | 258 KB 18/08/2022 Scope of Accreditation | 445 KB New 11/09/2024 The pharmaceutical OMCL at 1220 Vienna, Spargelfeldstrasse [...] 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
GMP/ GDP New
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
active implantable medical devices. The In Vitro Diagnostic Devices Regulation applies since 26 May 2022 and it repeals Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic [...] quality documentation for medicinal products when used with a medical device ”, valid since 01.01.2022) and the EMA Q&A document in the current revision (EMA/37991/2019, “ Questions & Answers for applicants
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
2017/745 07/03/2022 Document: Guideline for the classification of change requests | 222 KB Guidance for classification and reporting of amendments during the clinical investigation 07/03/2022 Form: Changes [...] Regulation (EU) 2017/745 25/02/2022 Form: Changes with relevance for monitoring | 91 KB Changes to the investigation with significance for the regulatory oversight 25/02/2022 Form: Security measures, suspension [...] (EU) 2017/745 25/02/2022 Form: Termination notification | 44 KB Notification of completion of a clinical investigation according to Article 77 of Regulation (EU) 2017/745 25/02/2022 SAE Reporting Form |
0.xml | 892 B 30/03/2023 Meldung_Abgabe_valide-1_0.xml | 2 KB 13/09/2022 Freiwillige_Detailmeldung_valide-1_0.xml | 1 KB 13/09/2022 Abgabe-Leermeldung_valide-1_0.xml | 901 B 14/02/2024 Anwendungs-Leer [...] endung_und_Leermeldungen-1_0.xsd | 5 KB 14/02/2024 Freiwillige_Detailmeldung-1_0.xsd | 6 KB 13/09/2022 Meldung_Vertrieb-1_0.xsd | 4 KB 30/03/2023 Freiwillige_unterjährige_Detailmeldung-1_1.xsd | 6 KB
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
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 [...] the removal of the requirement to submit so-called "dispatch lists". See CMDh press release December 2022 and January 2023 . Furthermore, the CMDh agreed to update the CMDh position paper regarding applicant's
BASG after 01.01.2023. 16/12/2022 Gebührentarif 15.08.2022 | 560 KB The fees valid on the date of application at BASG after 15.08.2022. 05/08/2022 Gebührentarif 28.01.2022 | 509 KB The fees valid on the [...] the date of application at BASG after 28.01.2022. 25/01/2022 Gebührentarif 01.01.2022 | 331 KB The fees valid on the date of application at BASG after 01.01.2022. 20/12/2021 Gebührentarif 01.08.2021 | 679
19/12/2023 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