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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
Apothekenbetrieben (in German only) Form: delineation tool (F_I268) | 63 KB 23/12/2009 side lettter of BASG to delineation tool | 802 KB 21/12/2009
will now be sent to the European Commission for a legally binding decision. Recommendations of the BASG Recommendations for patients: Adrenaline auto-injectors are used to treat severe allergic reactions
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
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