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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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Content Legal foundations for tissue safety The role of the Federal Office for Safety in Health Care (BASG) in the context of tissue safety The role of the European Commission Definition of procurement es [...] European Parliament and of the Council. The role of the Federal Office for Safety in Health Care (BASG) in the context of tissue safety Contact person of the European Commission (Competent authority for [...] changes in the certificate or authorisation of a tissue establishment. Further inquiry note inspektionen@basg.gv.at
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 .
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
of the BASG decision will not be postponed. Applications for withdrawal are recorded in the order of receipt by BASG. A specific time prediction on processing, announcement and delivery of the BASG withdrawal [...] ion/registration: The BASG incoming date of the application for withdrawal is not relevant. The validity of withdrawal starts with the date of the withdrawal decision of the BASG. Application requiring [...] from 02.01.2014) 1. What services are paid for by the flat rate annual fee and how is it payable to BASG? 2. The marketing authorisations/registrations were withdrawn before the end of the quarter. Nevertheless
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
in a new marketing authorisation number or be integrated into the existing marketing authorisation. BASG processes the latter within the scope of the life cycle, which is why the marketing authorisation