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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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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
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"
Volume of Sales for each veterinary medicinal product to the Union Product Database (UPD). The data for 2022 should be submitted without delay , the deadline for 2023 data submission is the end of February 2024
defined terms are provided? Detailbeschreibung_bereitgestellter_Kataloge_ABVet.pdf | 149 KB 13/09/2022 What data does the medicinal product dataset contain? For antimicrobial veterinary medicinal products [...] large master data set according to Annex 1 (1.1.1) BGBl. II No. 83/2014 as amended and Regulation (EU) 2022/209 is provided. In addition to the basic data set, this contains additional data such as dosages [...] master data set according to Annex 1 (1.1.2) of BGBl. II No. 83/2014 as amended and Regulation (EU) 2022/209 is provided. Technical and user information can be called up here on a daily basis. Data Set
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
Medicinal Products Regulation, which entered into force on 27 Jan. 2019, is applicable from 28 Jan. 2022 . According to Article 9 of this Regulation, applications for approval of clinical trials of veterinary [...] Clinical Trials Veterinary". Fees The new fee schedule of the BASG, which came into force on 28 Jan. 2022, contains tariffs for the following services concerning the clinical testing of veterinary medicinal
RMS | 75 KB Request for RMS in a DCP for medicinal products for human use 07/02/2024 CMDh_442_2022_Rev.0_06_2022_MRP_RUP_Request_form | 57 KB Request for MRP/RUP for medicinal products for human use 07/02/2024 [...] 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