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the CD or DVD's be labelled? 3. are NeeS submissions still accepted by the BASG? 4 Why is the eCTD format preferred by the BASG? 5. what security measures must be observed for electronic submissions? 6 [...] responsibility of the applicant. Upon receipt by BASG the responsibility for the safety and integrity of the submission lies solely in the hands of BASG. Non-readable or defective data carriers are exclusively [...] Guideline: electronic Release Regulation EEVO (L_Z45) . 3. are NeeS submissions still accepted by the BASG? Yes, national applications for registration of homeopathic and pharmacy proprietary medicinal products
decided by the Pharmacovigilance Risk Assessment Committee (PRAC) are implemented in Austria by the BASG if they concern medicines approved in Austria. Legal basis Legal basis (Eudralex) for medicinal products
28(2)). Further information: The PSUR Repository website and the FAQs Pharmacovigilance https://www.basg.gv.at/en/companies/pharmacovigilance/faqs-pharmacovigilance are available for detailed information
Sicherstellung der Verfügbarkeit von Arzneimitteln das Bundesamt für Sicherheit im Gesundheitswesen (BASG). Die Antragstellung für die Auszahlung des Infrastruktursicherungsbeitrages wird ab 1.3.2024 auf [...] Bundesgesetzes über finanzielle Maßnahmen zur Sicherstellung der Verfügbarkeit von Arzneimitteln beim BASG zu stellen. Die Anträge sind gemäß § 2 Abs. 3 des Bundesgesetzes über finanzielle Maßnahmen zur S [...] Der Antrag ist mittels Online-Formular zu stellen. Das Online-Formular wird auf der Homepage des BASG zur Verfügung gestellt. Im Antrag hat der Antragssteller seine persönlichen Daten, die Stückzahl der
found here . Further information can be found here . For technical inquiries please contact basg-eservices@basg.gv.at Registration for applicants from mail-order pharmacies As of June 25, 2015, Austrian [...] of distance selling of veterinary medicinal specialties to the BASG Public pharmacies that have already notified their activities to the BASG in accordance with Section 59a para. 2 AMG as amended are exempt [...] Regulation (EU) 2019/6 on veterinary medicinal products. The Federal Office for Safety in Health Care (BASG) is responsible for enforcing the provisions regarding the registration and supervision of public
recommended precautions to avoid accidental hormone transmission to pets. Topische Hormonersatztherapie BASG | 222 KB in German only 29/02/2024
wordings for the active substance(s) EMA: Medicines under Additional Monitoring EMA: QRD-Template BASG German QRD-Template accessible EMA: Names of the EU / EEA countries - german diction of EU/EEA member
products currently authorised in Austria can be found in the Austrian Medicinal Product Index of the BASG under "Drug category"/"herbal medicinal products". For registered traditional herbal medicinal products [...] currently approved and registered in Austria can be found in the Austrian Medicinal Product Index of the BASG under "Drug Category"/"Homeopathics". Further information on homeopathic medicinal products can be
Safety in Health Care (BASG). In the case of direct use, it is the respective institution that shall submit the notification to the Federal Office for Safety in Health Care (BASG). What is the reporting [...] vigilance report to the tissue vigilance of the BASG. In the case of direct use, it is the respective institution that is to send the notification to the BASG. What is the reporting procedure for an event [...] in Health Care (BASG). When must the annual report on reactions and events be submitted at the latest? Annual reports must be sent to the Federal Office for Safety in Health Care (BASG) by 30 April at
Office for Safety in Health Care (BASG) about the rejection and the reasons for it. The applicant receives the objection in written form. The applicant may request the BASG to revise the decision to reject [...] ion holder in Austria on the market. The Austrian OMCL is the medicines control laboratory of the BASG. For plasma products that are licensed in Austria, also batch release certificates from other OMCLs [...] reject the batch. This has to be done by BASG within 30 days. Requests for further data (including analytical test results) prolong the deadline. The rejection of a batch has to be reported to the European