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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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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
2017/745 07/03/2022 Document: Guideline for the classification of change requests | 222 KB Guidance for classification and reporting of amendments during the clinical investigation 07/03/2022 Form: Changes [...] Regulation (EU) 2017/745 25/02/2022 Form: Changes with relevance for monitoring | 91 KB Changes to the investigation with significance for the regulatory oversight 25/02/2022 Form: Security measures, suspension [...] (EU) 2017/745 25/02/2022 Form: Termination notification | 44 KB Notification of completion of a clinical investigation according to Article 77 of Regulation (EU) 2017/745 25/02/2022 SAE Reporting Form |
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