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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
registration office, have I received an error message when I submitted my annual registration via the BASG portal? What do I have to pay attention to when "Submitting a message"? Where can I get the necessary [...] carried out to check whether the technical requirements have been met. Please contact AGES (e-mail: basg-eservices@ages.at) if you have any questions regarding the procedure of the Vet-AB-MengenströmeVO [...] carried out to check whether the technical requirements have been met. Please contact AGES (e-mail: basg-eservices@ages.at) if you have any questions about the procedure of this procedure. AGES will send
ance Union Product Database (UPD) Notification of pet products National Legislation / Information BASG talk NVR
Contact For technical questions about online services and eServices, please contact us at basg-eservices@basg.gv.at .
professionals electronic form human Paper form human paper form human by e-mail pharm-vigilanz@basg.gv.at by post BASG, 1200 Wien, Traisengasse 5 by fax + 43 (0) 50 555 36207 telephone support: + 43 (0) 50 555 [...] Industry Regulation Act 1994), are obliged to report adverse drug reactions occurring in Austria to the BASG pursuant to the Arzneimittelgesetz (Medicinal Products Act) and the Pharmacovigilance Ordinance ( [...] relatives also have the option of voluntarily reporting suspected adverse drug reactions directly to the BASG. Statistics of all reports, broken down by first and subsequent reports as well as by notifier can
wholesaler with the BASG. Under " Internet pharmacies " you will find the Internet pharmacies registered in Austria. All BASG decisions since 31.07.2013 are listed under BASG announcements and BASG votes (for previous [...] for use (package insert), the summary of product characteristics for health professionals, and the BASG assessment report on this product. The Medicine Shortages Catalogue presents all reported procedures [...] those proprietary medicinal products which have been banned from parallel export after review by the BASG. The Register of pharmaceutical companies authorised according to §63 AMG contains all establishments
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
a product on the market may submit an application to the Federal Office for Safety in Health Care (BASG) to determine whether this product falls within the definition of a medicinal product or a veterinary [...] documents. Within the scope of this procedure, pursuant to Section 1 (3b) AMG or Section 2 (5) TAMG, the BASG may obtain an expert opinion of the Delineation Commission pursuant to Section 49a AMG or Section [...] Alternatively, persons wishing to place a product on the market can submit an informal enquiry to BASG by e-mail , which is answered by e-mail without a formal expert opinion and without notification.