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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
the problem to basg-eservices@basg.gv.at . Afterwards we analyze your problem and we will inform you within a few working days. Why do I have to register my company/organization with the BASG/AGES Medizi [...] One staff member can be assigned to several companies/organizations (please contact us via basg-eservices@basg.gv.at ). My company/organization has various local affiliates acting as MAHs. Do we have to [...] internal staff members as well as to staff members of a consultant company. Please contact us via basg-eservices@basg.gv.at . so that our support can enter data accordingly How can I register my company/organization
any agreements on content with the BASG. They are therefore not suitable for comparison with inspection results of the BASG and are of no legal significance for the BASG. In the event that hazardous practices [...] practices are identified by the third country authority and reported to the BASG, the BASG is obliged to initiate corresponding activities. [...] implementation of draft laws in our QM landscape. Can the Inspectorate act as a consultant here? No. The BASG offers the inspection of a design qualification to verify plans/projects/changes. The inspection of
email to basg.fakturierung @ages .at ("F_M70_Ermaechtigung_Administrator_Portal"). In case the administrator is not available anymore, and can thus not initiate the change, please contact us via basg-eservices [...] necessary to newly register for the platform. To update data, please send an email to basg.fakturierung @ages .at. basg.fakturierung@ages.at As administrator, when creating a new user, the system shows an [...] external staff members (e.g. of a consultant company). In this case please contact us via email to basg-eservices @ages .at so that our support can enter data accordingly. Further, please refer to the "Guidance
Mock-ups AT Guidance document – Mock-ups This guidance document summarizes the legal basics and the BASG requirements with regards to the mock-ups of human and veterinary medicinal products there by providing
manufacturer's recommendations into account. No special calibration intervals are prescribed by the BASG. During inspections, however, the justification for the periodic functional tests and the suitability [...] brought to the attention of the Ethics Committee before they take up their duties. Information to the BASG is only required if contents of the EudraCT notification form are concerned. This notification can
Where to report You can report your suspicion to us via mail or email. Mail address: enforcement@basg.gv.at Postal address: Federal Office for Safety in Health Care, Institut Überwachung - Enforcement [...] is possible without danger. A list of all Austrian distance selling pharmacies can be found on the BASG homepage.
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
Information Shortages Based on reports from pharmaceutical companies, BASG informs about current shortages. Shortages read more Reporting to BASG The Federal Office relies on reports from consumers, health care [...] information from the BASG directed to consumers (patients, their relatives and owners of animals). read more For Health Care Professionals This is the subpage with information from the BASG directed to health [...] subpage with the official announcements and public databases provided by the BASG as well as procedures for reporting to BASG. read more
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.