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datenschutz@basg.gv.at . The legal framework is laid down in the Health and Food Safety Act (GESG), Federal Law Gazette I No. 63/2002 as amended. In fulfilment of its statutory duties, the BASG is entitled [...] to the processing of personal data: a. Legal basis The tasks of the BASG are defined in § 6a GESG. In fulfilling these tasks, the BASG is entitled to process personal data pursuant to § 9 para 7 GESG. In [...] ing provisions authorising the BASG to pass on personal data can be found in the relevant material laws (e.g. Section 80 of the Medicines Act). 4. Data security The BASG provides for technical and org
parties whose activities are regulated by the material laws under the jurisdiction of the BASG. The services of the BASG are available to all applicants and notifiers who are entitled under the material laws [...] Section 82a of the German Medicines Act (AMG), all employees of the BASG and the AGES MEA are obliged to submit annual declarations to the BASG regarding any grounds for bias. The criteria used for the evaluation [...] Safety Act (GESG) with the execution of the tasks of the Federal Office for Safety in Health Care (BASG). Pursuant to § 8 (7) GESG, the acceptance of third party contracts is prohibited for this business
in Health Care (BASG) AGES Austrian Medicines and Medical Devices Agency Traisengasse 5 A-1200 Vienna Tel. national: 050 555-36111 Tel. international: +43 (0)50 555-36111 E-Mail: basg@basg.gv.at Responsible: [...] MDRA (Member of the BASG responsible for the procedure and Head of the AGES Austrian Medicines and Medical Devices Agency) Internet editorial office: E-mail: redaktion-basg@basg.gv.at Disclosure pursuant [...] the website, please contact redaktion-basg@basg.gv.at . Disclaimer Here you can find our privacy policy . Editorial content management, conception & specification: BASG / AGES Austrian Medicines and Medical
signatures, please visit signature verification or submit a request for verification at the BASG ( basg@basg.gv.at ) . Legal basis: Federal Electronic Signature Law - Federal Act on Electronic Signatures [...] Official electronic signature Secured publication of figurative mark of BASG The Federal Office for Safety in Health Care (BASG) uses the following two figurative marks for the electronic signature of
Press Media contact presse-basg@basg.gv.at We are very happy to support you with inquiries from the following areas: Pharmaceuticals (registration, pharmacovigilance, counterfeit drugs) Medical devices
ices@basg.gv.at. For specialist issues please contact: basg-heve@basg.gv.at [...] marketed in Austria if they have been notified to the BASG with the information required for the Union Product Database ( Union Product Database (UPD) - BASG ). The exemption from the marketing authorisation [...] registration is required. Further details on registration can be found on the BASG website in the section FAQ online Service - BASG . Notification of a pet product To notify a pet product in accordance with
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
templates for PDF with unlimited access (PDF/UA) The BASG has updated the accessible versions, which are available for download at https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycl [...] information please refer to Accessible patient information leaflet - BASG , resp. FAQ Accessible patient information leaflet - BASG . CMDv - call for early submission and statistics Please find the call [...] SmPC, package leaflet and labelling . For further information please refer to FAQ online services - BASG . Based on the final package leaflet , an accessible PDF document has to be created and also uploaded