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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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Regulations", "CTR") are contained in the Austrian Medicines Act (AMG), Federal Law Gazette I No. 8/2022 . The competent authority in terms of the CTR is the Federal Office for Safety in Health Care (BASG)
NVR BASG offered a BASG talk (BASG-Gespräch) on the New Veterinary Medicines Regulation on 8 Nov. 2022, and the programme and slides have been filed here: https://akademie.ages.at/basg-gespraech_nvr__
changes Gebührentarif Verordnung Nr.2-2022 | 388 KB 16/12/2022 Gebührentarif Verordnung Nr.1-2022 | 65 KB 05/08/2022 Gebührentarif Verordnung Nr.3-2021 | 355 KB 25/01/2022 Gebührentarif Verordnung Nr.2-2021
BASG after 01.01.2023. 16/12/2022 Gebührentarif 15.08.2022 | 560 KB The fees valid on the date of application at BASG after 15.08.2022. 05/08/2022 Gebührentarif 28.01.2022 | 509 KB The fees valid on the [...] the date of application at BASG after 28.01.2022. 25/01/2022 Gebührentarif 01.01.2022 | 331 KB The fees valid on the date of application at BASG after 01.01.2022. 20/12/2021 Gebührentarif 01.08.2021 | 679
In accordance with its role in crisis preparedness as defined in EU Regulation 2022/123, the EMA published on 8 th July 2022 the list of the main therapeutics groups (MTGs) in crisis preparedness that are [...] meets regularly and the BASG represents Austria. For crisis preparedness and management, Regulation 2022/123 foresees a reinforced role for EMA, which is performed by the Executive Steering Group on Shortages [...] Rapid communication with partners from the industry - i-SPOC contacts According to EU Regulation 2022/123, marketing authorisation holders must register an Industry Single Point of Contact (i-SPOC)" for
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Reports Facts Folder 2023 | 1,014 KB 21/11/2023 Facts Folder 2021 | 587 KB 21/12/2022 Jahresbericht 2018/2019 | 10 MB 15/12/2022 Annual Report 2016/2017 | 2 MB 06/12/2019 Jahresbericht 2015 | 2 MB 10/03/2021
25/05/2022 Form: Defective product report template for pharmacies and wholesalers (F_I55) | 55 KB Available in German only Defective product report template for pharmacies and wholesalers 25/05/2022 Form: [...] Available in German only Defective product report template for marketing authorisation holders 25/05/2022 Documents of interest "Compilation of Union Procedures on Inspections and Exchange of Information"