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).
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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
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 |