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)

s. 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

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__

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

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

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

products (VMP) regulation The Veterinary Medicinal Products Regulation (EU) 2019/6 is valid from 28 Jan. 2022. It replaces Directive 2001/82/EC and Regulation (EC) 1234/2008 (as far as Tierarzneimittel (TAMs)

Code of Conduct applies to the employees of the Austrian Medicines and Medical Devices Agency 10/05/2022 Strategic objectives 1. Ensuring sustainable and successful positioning on the market and within the

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and notifications (Electronic Ordinance on Submissions 2011 - EEVO 2011) version 30.07.2022 | 58 KB 01/08/2022 Ordinance of the BASG on the electronic transmission of applications and notifications ( [...] medical devices (German only) Ordinance of the BASG on fees for medical devices, version 30.07.2022 | 75 KB 01/08/2022 BASG on official badge (German only) BASG communication on official badges, version 30.01