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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
address entries in EMA's organisation management OMS. You can find more details here: https://www.basg.gv.at/marktbeobachtung/amtliche-nachrichten/detail/organisation-management-service-oms-integratio
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
instructions for use are available at: https://www.basg.gv.at/fuer-unternehmen/online-service/nutzungshinweise Endpoint public Internet https://webservices.basg.gv.at/medicineshortage/export/v1/download Endpoint [...] healthcare professionals (yes/no) Rechtsgrundlage_Meldung Legal basis of the notification Hinweis_BASG Important BASG-information (optional) Information of the medicinal product per pack size Zulassungsnummer [...] Endpoint GIN https://webservices-ginet.basg.gv.at/medicineshortage/export/v1/download General information Since February 1, 2018, marketing authorisation holders and their authorised representatives have
adverse drug reactions directly to the BASG. Physicians, pharmacists and other health care professionals are legally obliged to report adverse reactions. https://www.basg.gv.at/en/market-surveillance/repor [...] shortly afterwards ("background incidence"). In Austria, the Federal Office for Safety in Health Care (BASG) records all suspected adverse reactions to medicinal products and vaccines that have occurred in