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65 (3) of the Austrian Medicines Act via electronic submission in the eService (https://eservices.basg.gv.at/ ). The following key personnel are not subject to notification : - Head of Production: requirements [...] responsible person according to § 9 (4) GSG via electronic submission in the eService (https://eservices.basg.gv.at/ ) are subject to notification in advance or without undue delay in case of unforeseen changes [...] undue delay in case of unforeseen changes via electronic submission in the eService (https://eservices.basg.gv.at/) . e. Licence holder: Pursuant to § 56 (2) of the Austrian Medicines Act (AMG ) as amended
certification documents and the final report are sent to the Federal Office for Safety in Health Care (BASG). The procedure has now been completed ( AVG ). Electronic submission The in the following listed
clinical trials Interventional clinical trials must be approved by both the regulatory authority (BASG) and the ethics committees. The submission documents consist of the following three parts: information
Referrals and PSUSAs will be published on the BASG homepage ( PV-wordings ) When submitting the variation, please state the following in accordance with the BASG letter in the coverletter ( e.g. ' PHV-Issue:
medicinal products) and send it to BASG if an import certificate or a certificate of marketability according to the Medicinal Products Import Act (AWEG) is to be applied for at BASG. Note: If, in the case of [...] notification for the study medication has to be sent to the Federal Office for Safety in Health Care (BASG) in any case. For this purpose, please use the electronic reporting portal to be used since 04.07 [...] Notifications (Electronic Submission Ordinance 2011 - EEVO 2011; published in the Official Gazette of the BASG ), applications and notifications under the AWEG have to be submitted in electronic form since 04
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