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II National fees Appeal procedure National contact point and concerned ethics committees March 28, 2023 The national legislation supplementing Regulation (EU) 536/2014 ("Clinial Trials Regulations", "CTR") [...] an agreement. This agreement will be published shortly. Decision by the Federal Office December 14, 2023 The decision on an application (initial application or substantial modification) is made by the Federal [...] subject understands. Document templates for FORM section and national aspects ("Part II") December 14, 2023 Harmonized Templates and Documents: For the following FORM section and Part II documents, the templates
RezeptPG 1972 Rezeptpflichtgesetz - 1972 Contribution to infrastructure safety - ISB 2023 Infrastruktursicherungsbeitrag - ISB 2023 Distance Selling - 2015 Fernabsatz-Verordnung - 2015 Electronic Submissions - [...] 2008 Gewebevigilanzverordnung - GVVO 2008 Veterinary Medicinal Products Act - TAMG 2023 Tierarzneimittelgesetz - TAMG 2023 Eudralex The body of European Union legislation in the pharmaceutical sector is compiled [...] devices (MDR) Regulation (EU) 2017/746 on in vitro diagnostics medical devices (IVDR) Regulation (EU) 2023/607 amending the transitional provisions Directive 93/42/EEC concerning medical devices - legacy devices
Medicines Act. Implementation of the Veterinary Medicinal Products Act Federal Law Gazette I No. 186/2023, to the extent the Federal Authority for Safety in Health Care is responsible for such implementation
Kick Off Meeting CHESSMEN, Rome, 10.02.2023 02/03/2023 QA_Meeting_Roma_230210.pdf | 331 KB Questions & Answers - Kick Off Meeting CHESSMEN, Rome, 10.02.2023 02/03/2023 International Networking Representatives
english only, aiming particularly at international partners and stakeholders. 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
medicinal products - in German only Arzneispezialitäten Übersicht 2023 | 110 KB 02/02/2024 Zulassungen Registrierungen Zusatzdaten 2023 | 99 KB 02/02/2024 MRP/DCP AT RMS The CMDh publishes bi-annual/annual
Veterinary Clinical Trial (F_Z136) | 71 KB 30/03/2023 Guidance for submission and authorisation of veterinary clinical trials (L_Z169) | 268 KB 30/03/2023 Detailed information on: Submission of the clinical
30 Dec 2023, which defines the implementation of the Veterinary Medicinal Products Regulation (EU) 2019/6 and supplementary provisions at national level ( https://www.ris.bka.gv.at/eli/bgbl/I/2023/186/20231230
Union Product Database (UPD). The data for 2022 should be submitted without delay , the deadline for 2023 data submission is the end of February 2024 . For further details see the CMDv website and EMA UPD
invited to fill in this form: https://ec.europa.eu/eusurvey/runner/2023_MAHSurvey_SPCH , which may be submitted by before 31st of May 2023 . For any question regarding the form, please contact the CMDv s