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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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medicines agencies. The Austrian Medicines and Medical Devices Agency had its BEMA V visit in March 2023. For more information please visit HMA .
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
12/10/2023 103. Anlage der Geschäftsordnung des BASG | 345 KB 05/05/2023 102. Anlage der Geschäftsordnung des BASG | 341 KB 13/03/2023 101. Anlage der Geschäftsordnung des BASG | 156 KB 20/01/2023 100.
the requirements for medicinal products for human use in the document 'Blue-box' requirements may 2023 published on the CMDh website in the section „ Procedural Guidance – Application for MA “. The Blue
Meldung_Vertrieb-1_0.xsd | 4 KB 30/03/2023 Freiwillige_unterjährige_Detailmeldung-1_1.xsd | 6 KB 16/08/2024 Example messages Meldung_Vertrieb_valide-1_0.xml | 892 B 30/03/2023 Meldung_Abgabe_valide-1_0.xml | [...] 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
Regulation 2007 (HäVO 2007) Contributions towards Security of Pharmaceutical Infrastructure Act (ISB) 2023 Pharmaceutical Labelling Regulation 2008 Regulation on Pharmacovigilance 2013 (PhVO 2013) Prescription [...] devices („MDR“) Regulation (EU) 2017/746 on in vitro diagnostic medical devices („IVDR“) Regulation (EU) 2023/607 amending the transitional provisions Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 [...] MDCG Guidance Documents Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending the transitional provisions Harmonised Standards - MDR Harmonised Standards - IVDR Further
Berichtsjahr 2023 steht Ihnen ab sofort zum Download bereit. Handbuch zur Befuellung des Suchtmittelnachweisungsformulars 2023 (L_I120) | 2 MB 28/12/2023 Suchtmittel Nachweis 2023 (F_I20) | 4 MB 28/12/2023 Für [...] 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
Article 7(2) of the Austrian Veterinary Medicinal Products Act (TAMG, Federal Law Gazette I No 186/2023) With application of the new European Veterinary Medicinal Products Regulation (EU) 2019/6, herd- [...] into force of the Austrian Veterinary Medicinal Products Act (TAMG, Federal Law Gazette I No. 186/2023), which is based on the Regulation (EU) 2019/6, these inactivated vaccines, which are not subject
website at this link . MRP/DCP statistics for 2023. The CMDh has presented its annual statistics on DC/MR procedures for 2023 according to the CTS database. In 2023, Austria as RMS was in 7th place for finalised [...] The update takes into account the new standard renewal procedure, which was introduced in February 2023 and specifies whether the requirements for a renewal, a variation or both apply. It also lists those [...] of committees and working parties RMS flyer Allocation scheme Current slot matrix NEWSTICKER 31.10.2023 RECENT COMMITTEE NEWS Overview of EU safety assessment outcomes. Marketing authorisation holders are
to mid-2023, the BASG provided the current, German-language Summary of Product Characteristics for centrally approved COVID-19 vaccines in Europe. This service was discontinued in November 2023. For the