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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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charge and will also be made available as a recording. BASG fee schedule for clinical studies As of 01 January 2023 , an updated fee tariff of the BASG was put into force. From this date, index-adjusted tariffs [...] products - REG (EU) 536/2014 Overview Clinical trials' transition to new EU system - one year left! BASG fee schedule for clinical studies Information and training material Clinical trials' transition to [...] products was suspended in 2022! The same fees apply as for commercial studies. Please refer to the BASG fee schedule for the current fees. Information and training material Information from the European
amended as stipulated. The change has to be notified to the Federal Office for Safety in Health Care (BASG). For marketing authorisation procedures that are still ongoing, the amended PL will be authorised
on medicine shortages What is the BASG's role in connection with distribution restrictions? What is the BASG's role in connection with distribution restrictions? The BASG provides information on its website [...] special situation" What can the BASG not do in connection with distribution restrictions? What can the BASG not do in connection with distribution restrictions? The BASG cannot oblige companies to produce [...] which have been banned from parallel export after review by the BASG. Notifications of discontinuation of placing on the market The BASG must be notified four months in advance of a temporary or permanent
storage and to determine any deviations shall be conducted and records maintained. - Inspections by BASG can be carried out at such warehouses on a random basis as part of an inspection. Are medical sample
submitted to the BASG, on the basis of which the drug will be re-examined. If the result is positive, the extension takes place. Any changes to medicinal products must also be submitted to the BASG for approval [...] of the Austrian Drug Law is one of the main tasks of the Federal Office for Safety in Health Care (BASG). During the authorisation process, the experts check the efficacy, safety and quality of the drug
"from 1.5. 2023" or as a time period after the date of approval by the BASG e.g. "two months from the date of approval by the BASG"). In this case, the change in the dossier takes place with the implementation [...] IB and Type II variations (human) or Variations requiring assessment (VRA, veterinary), the date of BASG approval ("Approval Date") is the date of the dossier variation ("Implementation Date"). If no further [...] batches must be certified/released in accordance with the new dossier from the date of approval by the BASG. In the eAF, however, it is also possible to specify an implementation date in the future (either
Internet pharmacy concerned. In Austria, this is the Federal Office for Safety in Health Care (BASG). The BASG website lists all registered online pharmacies in Austria that are allowed to sell over-the-counter [...] sells medicines via the Internet is registered with the responsible supervisory authority (in Austria: BASG) and is subject to its supervision. It must meet the quality requirements laid down in the Medicines
Questions or reports regarding illegal websites: BASG / Enforcement: E-Mail: enforcement@basg.gv.at All reports about illegal websites will be checked by the BASG-Enforcement group. [...] illegal websites checked by the BASG that violate Austrian or European law. The information noted on the place of registration refers to the time of inspection by the BASG. Often blocked websites are re
(notification of change) to the BASG. The application has to be handled via eService . Incoming applications will be ranked according to the date of their arrival at the BASG and, if possible, processed in [...] certification documents and the final report are sent to the Federal Office for Safety in Health Care (BASG). The procedure has now been completed. (AVG) If you have further questions about the inspection procedure [...] operating locations, new premises, new processes, new equipment,...) in my company be reported to the BASG? 7. Is IVF (couple treatment) possible in the presence of an infectious disease (e.g. HIV)? 8. If
DCP/MRP/RUP/SRP Slots BASG as RMS Please find below information about our available slots. BASG will accept to act as RMS for as many submissions as possible within the limitation of its assessment resources [...] contact Human and Veterinary Medicinal Products: rms@basg.gv.at For general requests concerning DC-, Repeat Use-, SR- and MR-procedures please contact BASG via: Tel. national: 050 555-36666 Tel. international: [...] become available at short notice. If you are interested in a short-term slot, please contact us via rms@basg.gv.at . Last updated: 01.08.2024 Quarter CHEM VETE HERB BIOL 3/2024 clear no resources available clear