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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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13/10/2022 Berichtszeitraum 27.12.2020-26.08.2022 | 159 KB 29/08/2022 Berichtszeitraum 27.12.2020-22.07.2022 | 162 KB 26/07/2022 Berichtszeitraum 27.12.2020-24.06.2022 | 163 KB 30/06/2022 Berichtszeitraum [...] – 27.05.2022 | 160 KB 31/05/2022 Berichtszeitraum 27.12.2020 – 22.04.2022 | 167 KB 28/04/2022 Berichtszeitraum 27.12.2020-08.04.2022 | 166 KB 14/04/2022 Berichtszeitraum 27.12.2020-25.03.2022 | 166 KB [...] KB 30/03/2022 Berichtszeitraum 27.12.2020-11.03.2022 | 166 KB 24/03/2022 Berichtszeitraum 27.12.2020-25.02.2022 | 143 KB 03/03/2022 Berichtszeitraum 27.12.2020-11.02.2022 | 140 KB 15/02/2022 Berichtszeitraum
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)
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
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
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
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
Data provision medicine shortages Update March 2022 In order to enable a simple integration of current contents of the „Shortages catalogue“ into external IT systems, two endpoints are provided in a pilot [...] REST-based API retrieval options is already being planned and is expected to be completed from Q2/2022. Release Notes The data file is created daily (between 0:00 and 4:00 am) and made available on the
the identification number 0198). Confirmation of Accreditation | 258 KB 18/08/2022 Scope of Accreditation | 5 MB 18/08/2022 The pharmaceutical OMCL at 1220 Vienna, Spargelfeldstrasse 191 voluntarily renounced [...] continues to further develop an effective quality management system. Certificate (ISO 9001) | 857 KB 27/09/2022 Accreditation in accordance with ISO 17025 The laboratory activities of the Official Medicines Control [...] the OMCL-Network . EDQM Audit Attestation 2021 | 84 KB 15/12/2021 Scope of Assessment | 179 KB 05/01/2022 BEMA (Benchmarking of European Medicines Agencies) The Heads of Medicines Agencies (HMA) have established
188 KB 25/01/2018 Formular: PSUR Zyklusänderungen (F_B23) - only available in German | 97 KB 24/11/2022