What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
For the RSS feed with daily notification of updates, use the link: RSS feed to "what's new".
Search narrowed by
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
ance Union Product Database (UPD) Notification of pet products National Legislation / Information BASG talk NVR
C3%A4ufig-gestellte-Fragen-zum-Thema-Impfungen.html Does BASG provide individual vaccination advice? No. As the official Medicines Agency, BASG can merely provide information about which vaccines MAY be [...] FAQ Vaccines Frequently asked questions about vaccinations - Federal Ministry of Health Does BASG provide individual vaccination advice? Which studies and controls have to be performed before vaccines
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
Legal ordinances of BASG BASG on electronic transmission of applications and notifications (German only) Ordinance of the BASG on the electronic transmission of applications and notifications (Electronic [...] medical devices (German only) Ordinance of the BASG on fees for medical devices, version 30.07.2022 | 75 KB 01/08/2022 BASG on official badge (German only) BASG communication on official badges, version 30 [...] Ordinance of the BASG on the electronic transmission of applications and notifications (Electronic Ordinance on Submissions 2011 - EEVO 2011) version 30.07.2022 | 58 KB 01/08/2022 Ordinance of the BASG on the