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safety officers of hospitals, must immediately report to the Federal Office for Safety in Health Care (BASG) any serious incidents of which they become aware as a result of their professional activities. The [...] there is a suspicion of counterfeiting of a medical device, this must be reported immediately to the BASG. Products involved in incidents must not be destroyed, but must be subjected to a root cause analysis [...] para. 4 MPG 2021 ) In connection with Safety instructions in the field, or notifications from the BASG about existing health hazards from implants, the healthcare facilities or physicians responsible for
Sampling reference substances form (F_L677) Further inquiry note basg.cpaa@basg.gv.at Assessment of Certificates of Suitability (CEP) BASG is involved in the assessment of CEPs („Certificate of Suitability [...] Picture 1 Picture 2 Picture 3 Enqueries: E-mail: nat@basg.gv.at Enqueries (for media): Communications Management, Tel.: 050555/25000 E-mail: presse-basg@basg.gv.at Quality defect Information on how to report [...] questions regarding NCRs please contact am-qualitaetsmangel@basg.gv.at , in case of questions regarding concerned products please contact lcm@basg.gv.at . Risk assessment of nitrosamines in medicinal products
Suggestions and wishes | eSubmission@basg.gv.at | +43 (0) 50 555-36033 eCTD Validation Criteria Validation criteria for the technical validation of eCTDs The BASG / AGES Medizinmarktaufsicht uses the published [...] 84 MB Zip-Datei des AGES e-Validator 23.2 16/11/2023 feedbacks Suggestions and wishes eSubmission@basg.gv.at Technical Validation Guidance for the technical validation of eCTD, NeeS and VNeeS submissions
medicines under additional monitoring . Further information Electronic national reporting system of the BASG. Websites of the European Medicines Agency (EMA): Medicines under additional monitoring Good phar
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
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
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
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