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

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

(F_L381) | 44 KB 01/11/2018 Released Products 2006-2023 Plasma derived products 2006-2023 (diagram) Plasma pools 2006-2023 (diagram) Vaccines 2006-2023 (diagram) Special Services to Shorten and Simplify

will also be made available as a recording. BASG fee schedule for clinical studies As of 01 January 2023 , an updated fee tariff of the BASG was put into force. From this date, index-adjusted tariffs will

ongoing, the amended PL will be authorised as part of the dossier. Reference: CMDh/258/2012/Rev.May 2023 8. Do these provisions apply to parallel-imported medicinal products? Yes. 9. If the regulation is

Safety of Medicinal Products (MSSG) Provision of data on the availability of antibiotics during winter 2023/24 for the EU-wide assessment of the situation via EMA and HERA Develop and implement the national [...] of the European Shortages Monitoring Platform (ESMP) by February 2025. The ESMP roadmap as of June 2023 is publicly available on the EMA website. The BASG is also working in this area to be able to provide [...] and EMA have published the first version of the Union list of critical medicines on the 12 December 2023. It contains more than 200 active substances of medicines for human use considered critical for healthcare

g. implementation date would be 1.5.2023; however, the company-internal changes are already completed on 1.4.2023. The batch to be certified / released on 15.4.2023 should already be done according to [...] also possible to specify an implementation date in the future (either as a fixed date e.g. "from 1.5. 2023" or as a time period after the date of approval by the BASG e.g. "two months from the date of approval

licence, suspicion of fraud, suspicion of counterfeit medicines, potential health risks Date: 28/04/2023 hilfenervenschmerzen.com/index_plzze.php Information about this website: no safety logo for mail-order [...] supply of medicines without a pharmacy licence, suspicion of fraud, potential health risks Date: 27/04/2023 fatburnerking.at Information about this website: no safety logo for mail-order pharmacies, website [...] licence, suspicion of fraud, suspicion of counterfeit medicines, potential health risks Date: 30/03/2023 meridetoxshop.com Information about this website: no registered mail-order pharmacy, no safety logo