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BASG and companies News Information The new Veterinary Medicinal Products Regulation is to be applied as of 28.01.2022, further information can be found here: The new Veterinary Medicinal Products Regulation [...] is to be applied as of 28.01.2022, further information can be found here: read more Reporting to BASG The Federal Office relies on reports from consumers, health care professionals and companies for the [...] continuous re-evaluation of the safety profile of medicinal products and medical devices. Reporting to BASG read more BREXIT The transition period ended on 31.12.2020. Marketing authorisation holders are reminded
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
with the involvement of the Ministry of Health and the Federal Office for Safety in Health Care (BASG). The Supervisory and Control Advisory Board of AMVO exercises the supervisory and control powers [...] medicinal products an email with subject „application for § 3a AMBO 2009“ should be forwarded to cp@basg.gv.at . identifyer sticker | 48 KB 12/02/2019
Austrian Medicinal Product Index (all medicinal products regardless of the authorisation date) and BASG-Announcement (recently authorised medicinal products) If the final classification of the prescription
pending, simply notified by sending the information to the appropriate mailbox ( rms@basg.gv.at , basg-cms@basg.gv.at or nat@basg.gv.at ) respectively. There are no costs arising with this notification, being