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save target as) 2. Open and fill in with Adobe Acrobat* 3. Send .xml and .pdf file to medizinprodukte@basg.gv.at * Adobe Acrobat Pro is required to edit the form 07/02/2024 MIR Helptext for reporting of serious [...] field safety information (FSN) in German and schedule for completing the FSCA to medizinprodukte@basg.gv.at 08/03/2024 Mandatory reporting for healthcare facilities and healthcare professionals Professionals [...] 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
in application form Step 5: Send the application form, document overview list and documents to: fsc@basg.gv.at Documents & Forms Instructions Documents-Overview Directive-Products Documents-Overview Prescription
information and, if necessary, submit a formal report to the BASG. If you still wish to contact BASG, please send an informal email to medizinprodukte@basg.gv.at . Your notification should include the information [...] root cause analysis. BASG itself does not conduct product investigations. Am I entitled to compensation or a replacement product? The BASG is not responsible for this question. BASG refers to consumer [...] relation to the benefits. What are the activities of the BASG in the field of medical devices? The Federal Office for Safety in Health Care (BASG) is the Austrian authority responsible for overseeing the
Importation Act (Arzneiwareneinfuhrgesetz, AWEG) The shipment of blood products has to be notified to BASG at least 3 weeks in advance (Art 14 AWEG). This has repeatedly resulted in problems when using the [...] needed but the 3-week waiting period applies, trial sites wish to hold IMP in stock, etc.). Therefore, BASG suggests a new, 2-step, procedure. A. Preliminary notification of estimated IMP requirements Step-by-step [...] IMP already imported up to the date of notification should be stated. (It has to be made clear to BASG how much IMP has already been shipped and how much IMP still requires shipment.) All of the other
Medicinal Product Index Pharmaceutical companies Register of retailers Internet pharmacies BASG official announcement BASG voting results Reporting Human adverse reaction notification Veterinary Adverse Event [...] monographs for comments Archive of monographs Archive of deleted monographs CHMP Meeting Highlights-BASG The CHMP introduces itself For Companies Online services Login online services Reporting adverse reactions [...] (PSURs) FAQ pharmacovigilance Guideline pharmacovigilance Medicinal products Scientific advice by BASG Quality of medicines Medicines for children Plasma derived products Batch release Recombinant proteins
current supply situation of certain radiopharmaceuticals, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed draws attention to particularities in the use of unauthorised medicinal products,
für Amtsärzte Zum Gebrauch für die Organe der Bezirksverwaltungsbehörde - Zur Verfügung gestellt von BASG / AGES OMCL Probenziehung gem. §70 ABO, BGBl. II Nr. 65/2005 (jeweils i.d.g.F.) Formular: Probenb
Apothekenbetrieben (in German only) Form: delineation tool (F_I268) | 63 KB 23/12/2009 side lettter of BASG to delineation tool | 802 KB 21/12/2009
will now be sent to the European Commission for a legally binding decision. Recommendations of the BASG Recommendations for patients: Adrenaline auto-injectors are used to treat severe allergic reactions
related to the Braille provisions must be submitted to the Federal Office for Safety in Health Care (BASG)? 5. What format should be used to make the information in the package leaflet available to blind [...] related to the Braille provisions must be submitted to the Federal Office for Safety in Health Care (BASG)? At the time of submission of the application dossier, the applicant has to specify, in Section 1 [...] Braille. After the product has been brought to market, the MAH has to submit, at the request of the BASG, a specimen of the outer packaging. The responsibility for checking the legibility of the texts presented