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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
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
medical device or in vitro diagnostic medical device. The Federal Office for Safety in Health Care (BASG) performs delimitation or classifications of medical devices or in vitro diagnostic devices based [...] Electronic Submission Regulation 2011, the notification has to be done by email to medizinprodukte@basg.gv.at . The European accredited reporting forms are to be used for reporting. For field safety corrective [...] are met. Please note the current Fee Regulation . To apply for a derogation, contact medizinprodukte@basg.gv.at in advance by e-mail.
Care (BASG) as well as the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer. Contact with the BASG should be made by e-mail to medizinprodukte@basg.gv.at [...] Health Care (BASG) must be informed at least 28 days before a relabelled or repackaged product is made available on the market. Please contact the BASG via e-mail to medizinprodukte@basg.gv.at .
Off-Label Use The BASG, the ÖGARI and the Austrian Patient Ombudsman have agreed on the following wording on the subject of off-label use. “Off-label use" refers to the use of a drug in the context of
exceeding the limits to trade (wholesale trade in medicinal products)." From the point of view of the BASG, the borderline to a trade is crossed if deliveries are made regularly or with the intention of generating
Product Index of the BASG under "Domain"/"Veterinary". You can report suspected side effects of veterinary medicinal products directly to the Federal Office for Safety in Health Care (BASG), Department HEVE [...] HEVE (Herbal, Homeopathic and Veterinary Medicinal Products): basg-v-phv@basg.gv.at
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