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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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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
licence, suspicion of fraud, suspicion of counterfeit medicines, potential health risks Date: 08/09/2022 helenkgilbert.store Information about this website: no safety logo for mail-order pharmacies, website [...] licence, suspicion of fraud, suspicion of counterfeit medicines, potential health risks Date: 17/08/2022 potenztabletten.shop Information about this website: no safety logo for mail-order pharmacies, website [...] licence, suspicion of fraud, suspicion of counterfeit medicines, potential health risks Date: 18/05/2022 vetloom.co Information about this website: no safety logo for mail-order pharmacies, website registered
act as RMS | 75 KB Request for RMS in a DCP for medicinal products for human use 07/02/2024 CMDh_442_2022_Rev.3_2024_04__clean_-_MRP_RUP_request_form | 59 KB Request for MRP/RUP for medicinal products for [...] CMDv_Request_for_RMS | 41 KB Request for MRP, SRP or DCP for medicinal products for veterinary use 21/02/2022 For further information please contact Human and Veterinary Medicinal Products: rms@basg.gv.at For
e Report 2022 | 1 MB Only available in German 11/10/2023 Haemovigilance Report 2021 | 567 KB corrected version of 14.09.2023 (only editorial changes compared to the publication of 29.11.2022) - Only available [...] Emergency Phone Number (24-Hours):: +43 (0)664 831 28 43 Fax: +43 (0)50 555-36408 Annual report From 01.1.2022, according to § 4 as well as § 6 Hemovigilance Regulation, the reporting parties are obliged to submit [...] online submission (The online reporting is only available in German.) Annual activity report From 01.1.2022, blood establishments (according to HäVO as amended) are obliged to submit an annual activity report
an ongoing shortage notification? With the amendment of the Austrian Medicines Act of February 14, 2022 and the associated change to Section 21 (2), the BASG must be notified of a temporary or permanent [...] four months (instead of two months previously) in advance (see also the message in brief of Feb 14, 2022 ). The notification must (as previously) be submitted via the eServices and published by the BASG
sheet for users of genetic resources including checklist | 165 KB 07/02/2022 Leitfaden inkl. Annex I und II | 1 MB 07/02/2022
Communication (DHPC) / Educational Material (EM) (L_Z100) | 325 KB Available in German only 03/02/2022
Renewal Applications according to § 20 AMG PSUR Formular: PSUR Zyklusänderungen (F_B23) | 97 KB 24/11/2022
Regulation is to be applied as of 28.01.2022, further information can be found here: The new Veterinary Medicinal Products Regulation is to be applied as of 28.01.2022, further information can be found here: [...] here: The new Veterinary Medicinal Products Regulation is to be applied as of 28.01.2022, further information can be found here: read more Reporting to BASG The Federal Office relies on reports from consumers