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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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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
violations of the relevant legislation. On behalf of the Federal Office for Safety in Health Care (BASG), the Enforcement Team handles all suspected cases of illegalities in the areas of the Medicines Act [...] laypersons, or to promise unrealistic treatment success, etc. If these requirements are exceeded, the BASG Medical Market Surveillance initiates detailed surveys. Execution and Prevention The primary objective [...] medicine bought from a legal source could be a counterfeit or illegal, this should be reported to BASG. A suspicion could, for example, be based on an unusual colour of the tablets, a different efficacy
the following link: https://medprodabgabe.basg.gv.at The self-declaration must be submitted in electronic form via the web form (link: https://medprodabgabe.basg.gv.at) . You will receive an RsB letter from [...] device - they fall neither under the Medical Devices Levy Ordinance nor under the jurisdiction of the BASG. General Independent of the registration in the medical device register, every natural or legal person [...] medical device levy has changed as of 1/1/2019: Click on the following URL: https://medprodabgabe.basg.gv.at Enter your identifier and password. You received your ID and password with the information letter
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
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
Please send the application for exemption from the requirement of batch release to hotline.euregulatory@basg.gv.at . If such an exemption to the batch release requirement is granted, Regulation on labelling [...] (‘Batch marketable’). All changes of the above mentioned conditions are subject to approval by the BASG. Otherwise, the licence for exception from the requirement of batch release will be deemed as cancelled