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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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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
Anleitung Installation e-Validator 23.2 (L_A112) | 218 KB 16/11/2023 AGES e-Validator 23.2 | 84 MB Zip-Datei des AGES e-Validator 23.2 16/11/2023 feedbacks Suggestions and wishes eSubmission@basg.gv.at Technical
available in German): List of nationally authorised medicinal products under additional monitoring_Q4-2023 | 193 KB 31/01/2024 The summary of product characteristics and the package leaflet (both only available
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
Handbuch zur Befuellung des Suchtmittelnachweisungsformulars 2023 (L_I120) | 2 MB 28/12/2023 Suchtmittel Nachweis 2023 (F_I20) | 4 MB 28/12/2023 Für die Dateneingabe des Suchtmittel-Nachweisungsformulars [...] xlsx | 320 KB 29/12/2023 Nachweisungsformular - in German only Das Nachweisungsformular für Suchtgifte und Psychotrope Stoffe samt dazugehörigem Benutzerhandbuch für das Berichtsjahr 2023 steht Ihnen ab sofort [...] Berichtsjahr 2023 ist als Anfangsbestand der gemeldete Endbestand aus der Nachweisung 2022 heranzuziehen. Jegliche Abweichungen vom gemeldeten Endbestand 2022 zu ihrem tatsächlichen Anfangsbestand 2023 (Ware
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
1_0.xsd | 6 KB 13/09/2022 Meldung_Vertrieb-1_0.xsd | 4 KB 30/03/2023 Example messages Meldung_Vertrieb_valide-1_0.xml | 892 B 30/03/2023 Meldung_Abgabe_valide-1_0.xml | 2 KB 13/09/2022 Freiwillige_Det [...] and reporting the use of veterinary antibiotics The new application report is available for the year 2023 as a separate data set. The option to submit this report is going to be available for the first time [...] software are available now . The new reporting interface in the AGES eServices will be available from mid-2023 . Information offer for practice software providers Practice software providers have the opportunity
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
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