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Austrian Medicines Act or § 42 Veterinary Medicinal Products Act Further inquiry note am-qualitaetsmangel@basg.gv.at Fax: +43 (0)50 555- 36408 Address for sending defect samples If you wish to send a defective [...] notification, please use the following laboratory address: Bundesamt für Sicherheit im Gesundheitswesen (BASG) Institut Begutachtung & Analytik / Abteilung CPAA Spargelfeldstrasse 191, 1220 Wien 24H number Please
AT). The BASG has to decide within 45 days after receipt of an application. After completion of the assessment, a corresponding decision will be issued. Please address any questions to qrd@basg.gv.at . [...] contact inspektionen@basg.gv.at . Downloads Guideline Exemptions AMG (L_Z173) | 328 KB 29/05/2024 Form Exemption Request §16/17 AMG (F_Z90) | 47 KB 29/05/2024 Further inquiry note qrd@basg.gv.at [...] Medicinal Product Index According to Art 27 AMG the Austrian Medicinal Product Index is published by BASG (Federal Office for Safety in Health Care) where defined data of all authorised and registered medicinal
should be made in writing and submitted to the address of BASG, Traisengasse 5 in 1200 Vienna, or by e-mail to the address recht@basg.gv.at . The BASG can then either issue a preliminary decision on the complaint [...] 8/2022 . The competent authority in terms of the CTR is the Federal Office for Safety in Health Care (BASG). Ethics Committees acting under the CTR are organised in a national platform and published on the [...] Committee for the Province of Salzburg the Ethics Committee of the Medical University of Vienna The BASG and the platform of Ethics Committees will define the details of their cooperation in an agreement
Tasks and Activities Tasks of BASG according to GESG Activities of BASG Tasks of BASG according to GESG Pursuant to Gesundheits- und Ernährungssicherheitsgesetz ( GESG ) § 6a. (1) The Federal Office for [...] Safety in Health Care gives scientific advice on the development of medicinal products. Activities of BASG Scientific Advice Admission of Clinical Trials Marketing Authorisation and Lifecycle Management of [...] Market Surveillance und Vigilance of Medical Devices Haemovigilance and Tissuevigilance Form: Process BASG (L A120) | 154 KB 20/03/2020
Reports and Facts Folder For resource reasons, replacing past practice of bilingual annual reports, BASG started in 2021 to publish an annual „Facts Folder“ in english only, aiming particularly at international
Statistics BASG statistics about medicinal products and medical devices Several statistics about authorisation, analyses, inspections and surveillance of medicinal products and medical devices are generated [...] generated by the BASG and published in its annual reports . From 2006 until 2015 those reports were prepared annually - since 2016 they are prepared every two years and all previous editions are published [...] ion procedures for medicinal products for human use, which you can find on the CMDh website . The BASG furthermore publishes the so-called RMS Flyer which inform about Austria's very successful activities
Health Care publishes annual reports and folders on selected topics. Scientific publications involving BASG staff are listed. Annual Reports and Facts Folder Folder Scientific Publications
companies. Companies can send personal data (name, telephone number, e-mail) to the BASG on a voluntary basis to suchtmittel@basg.gv.at informally, using the following text: "I hereby consent to the following [...] course of the narcotics inspection. Betriebsbewilligungen SMV und Ein- und_Ausfuhr | 982 KB 19/11/2018 BASG Aufgaben_Nachweisungen_Statistik_12_2018_V2 | 1 MB 17/12/2018 Anforderungen an SMV und Betriebe | [...] 2017-2018_11_2018 | 1 MB 05/12/2018 Contact details of establishments approved under addiction law The BASG maintains a list of companies in Austria that are licensed under controlled substances legislation
place. BASG talk 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-ge [...] justification must be attached to the application. Further information on the can be found at: https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycle/marketing-authorisation-procedure/addictive [...] prescription/prescription-of-medicines Fees The updated fee schedule has been published here: www.basg.gv.at/ueber-uns/gebuehrentarif . In addition to new fees for veterinary clinical trials, reduced fees
pre-clinic and clinic basg-heve@basg.gv.at Pharmacovigilance basg-v-phv@basg.gv.at Department Biologicals, Preclinical & Statistical Assessment Fee-based scientific advice scientificadvice@basg.gv.at For inquiries [...] Regulatory Affairs RMS procedures rms@basg.gv.at CMS procedures basg-cms@basg.gv.at National Procedures nat@basg.gv.at Other inquiries hotline.euregulatory@basg.gv.at UPC contact point upd-contact@ages