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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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MedSafety Week 2023 "Who can report?" - a call to patients and healthcare professionals to report suspected adverse reactions during #MedSafetyWeek: November 6-12, 2023. The Federal Office for Safety in
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
human antimicrobial medicinal products also provided? According to Regulation (EU) 2021/578, from 2023 on, data on antimicrobial medicinal products for human use (AM-HMPs), whose ATC-Code is listed in
There is an annual update of the xml file. AntibiotikaMengenstromanalyseASP_DDD_DCD.xml | 333 KB 26/09/2023 AntibiotikaMengenstromanalyseASP_DDD_DCD.xsd | 3 KB 31/03/2021
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