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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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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
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
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
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
general cover letter, must be submitted to the BASG via the Common European Submission Portal (CESP). Before or at the same time as the application to the BASG, the application for approval of the clinical [...] competent authority of the Member State in which the clinical trial is to be conducted. In Austria, the BASG is the competent authority for this purpose. Irrespective of this, the application for approval of [...] ion Before the start of each clinical trial, an application for approval must be submitted to the BASG. The documents required for proper submission are listed in the appendix of the application form "