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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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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 .
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
national product information on condition that the national product information will be submitted to BASG 4 months prior to the planned market launch of the medicinal product at the latest. Conditional a [...] the texts (see market launch). Market launch: The national product information must be submitted to BASG 4 months prior to the planned market launch. Submission of the texts with no open procedures: via [...] information as well. Finally the MAH will receive an approval letter (Genehmigungsschreiben) from BASG referring to the already issued conditional authorisation including the national product information
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
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
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
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
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