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für Amtsärzte Zum Gebrauch für die Organe der Bezirksverwaltungsbehörde - Zur Verfügung gestellt von BASG / AGES OMCL Probenziehung gem. §70 ABO, BGBl. II Nr. 65/2005 (jeweils i.d.g.F.) Formular: Probenb
account: The application for authorisation in Liechtenstein must be submitted to the Austrian authority (BASG) together with the application for authorisation in Austria in one application form. If both Austria
Please send the application for exemption from the requirement of batch release to hotline.euregulatory@basg.gv.at . If such an exemption to the batch release requirement is granted, Regulation on labelling [...] (‘Batch marketable’). All changes of the above mentioned conditions are subject to approval by the BASG. Otherwise, the licence for exception from the requirement of batch release will be deemed as cancelled
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 The marketing authorisations/registrations were withdrawn before the end of the quarter.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
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
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
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