Authorisation and Lifecycle Management of Medicines (L_Z34) | 1 MB 05/12/2023 Guidance Notes Medicine Shortages (L_I242) | 1 MB 07/04/2023 Further information regarding electronic application forms (eAFs) and

changes Gebührentarif_Verordnung_Nr.2-2024 | 163 KB 28/05/2024 Gebührentarif Verordnung Nr.1-2023 | 444 KB 19/12/2023 Gebührentarif Verordnung Nr.2-2022 | 388 KB 16/12/2022 Gebührentarif Verordnung Nr.1-2022

Referenced at:

• Fees

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

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

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

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

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

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