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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
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
responsibility, as applicable. Customer information on complaints and appeal management | 191 KB 01/02/2023 Emergency Contact Number Tel.: +43 (0) 664 831 28 43 Please note: The emergency number should only
medicines agencies. The Austrian Medicines and Medical Devices Agency had its BEMA V visit in March 2023. For more information please visit HMA .
processing of renewals in the Mutual Recognition and Decentralized Procedures” , version dated February 2023, the submission of an “Addendum to the clinical overview” is no longer required. AT=RMS: routinely
Regulation New Transition of clinical trials of medicinal products - the countdown is on! January 31, 2023 All ongoing clinical trials in the EU need to be converted to the Clinical Trials Information System
improve the usability and transparency of the CEP. The resulting CEP 2.0 was implemented on September 1, 2023. Further Information Database for information on CEPs granted by the EDQM: Search Certification Database [...] product Changes necessary due to performed the risk assessment had to be submitted by October 1st, 2023. CAVE: Please note that set deadlines for risk assessment (Step 1, 2 and 3) as described above for [...] medicinal product Changes necessary due to the performed risk assessment had to be submitted by July 1st, 2023. CAVE: Please note that set deadlines for risk assessment (Step 1, 2 and 3) as described above for
PHV issues. Due to the relaunch of the EMA website in December 2023, you will find the current links to the entries prior to December 01, 2023 at https://www.ema.europa.eu