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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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
über finanzielle Maßnahmen zur Sicherstellung der Verfügbarkeit von Arzneimitteln, BGBl. I Nr. 192/2023 , wurde die Einführung eines Infrastruktursicherungsbeitrags beschlossen. Anspruchsberechtigt sind [...] Infrastruktursicherungsbeitrag für Handelspackungen zu, die im Zeitraum zwischen dem 1. September 2023 und dem 31. August 2024 abgegeben wurden. Zuständige Behörde ist gemäß § 2 Abs. 1 des Bundesgesetzes [...] FAP-Kostenerstattungsgrenze für Human-Arzneispezialitäten Regelfall (alle Boxen und No Box): für im Jahr 2023 abgegebene Produkte: FAP in Höhe von 3,93 EUR für im Jahr 2024 abgegebene Produkte: FAP in Höhe von
to § 50 of the Veterinary Medicinal Products Act as amended (TAMG, Federal Law Gazette I. No. 186/2023), only authorized or registered veterinary medicinal specialties may be sold at a distance in Austria
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on the activities of the Austrian tissue establishments 2022 | 11 MB Only available in German 11/12/2023 Summary of the 2021 annual reporting of serious adverse reactions and events for tissues and cells [...] summary of the reports received from the Member States, written by the European Commission. 04/12/2023 Report on the activities of the Austrian tissue establishments 2021 | 9 MB Only available in German
Guidance applicants NASA (L_B65) | 139 KB 15/02/2024 Form: NASA application (F_B105) | 194 KB 14/07/2023 Form: NASA list of questions (F_B128) | 183 KB 21/07/2021 Pilot Simultaneous Scientific Advice Information
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