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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
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
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
the BASG, this provision must be interpreted as meaning that the marketing authorisation holder must be informed at the latest at the same time as the application; from the point of view of the BASG, there [...] or can the tray be labelled with the information required for the primary container? 14. How is the BASG to be informed about the products we display at the EMA? 15. In case of nat. approved preparations [...] authorisation,applicant shall be informed of application.Can the appl. be filed earlier? 16. Does the BASG also require a notification to this effect for centrally authorised products? 17. Is a translation
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
procedures exist for such products? 5. Will BASG inform me every time a marketing authorisation/registration is about to expire? 6. How do I notify the BASG of the date of actual marketing in Austria? [...] Please note: If no marketing data are available, BASG will assume that the proprietary medicinal product has not been marketed. 6. How do I notify the BASG of the date of actual marketing in Austria? Marketing [...] ion/registration holder will not receive a separate written confirmation from BASG that the request has been granted. BASG reserves the right to verify the accuracy of the information provided by the marketing
earlier than 30 days after finalisation of the procedure. If this is done before being contacted by BASG (Federal Office for Safety in Health Care) this lies within the responsibility of the MAH. 2. Which
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
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