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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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2001/20/EC. The reduction of tariffs for academic clinical trials of medicinal products was suspended in 2022! The same fees apply as for commercial studies. Please refer to the BASG fee schedule for the current
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)
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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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"
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