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Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
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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
Off-Label Use The BASG, the ÖGARI and the Austrian Patient Ombudsman have agreed on the following wording on the subject of off-label use. “Off-label use" refers to the use of a drug in the context of
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
national product information on condition that the national product information will be submitted to BASG 4 months prior to the planned market launch of the medicinal product at the latest. Conditional a [...] the texts (see market launch). Market launch: The national product information must be submitted to BASG 4 months prior to the planned market launch. Submission of the texts with no open procedures: via [...] information as well. Finally the MAH will receive an approval letter (Genehmigungsschreiben) from BASG referring to the already issued conditional authorisation including the national product information
medical device or in vitro diagnostic medical device. The Federal Office for Safety in Health Care (BASG) performs delimitation or classifications of medical devices or in vitro diagnostic devices based [...] Electronic Submission Regulation 2011, the notification has to be done by email to medizinprodukte@basg.gv.at . The European accredited reporting forms are to be used for reporting. For field safety corrective [...] are met. Please note the current Fee Regulation . To apply for a derogation, contact medizinprodukte@basg.gv.at in advance by e-mail.
Care (BASG) as well as the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer. Contact with the BASG should be made by e-mail to medizinprodukte@basg.gv.at [...] Health Care (BASG) must be informed at least 28 days before a relabelled or repackaged product is made available on the market. Please contact the BASG via e-mail to medizinprodukte@basg.gv.at .