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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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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
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
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
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 The marketing authorisations/registrations were withdrawn before the end of the quarter.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
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 problem to basg-eservices@basg.gv.at . Afterwards we analyze your problem and we will inform you within a few working days. Why do I have to register my company/organization with the BASG/AGES Medizi [...] One staff member can be assigned to several companies/organizations (please contact us via basg-eservices@basg.gv.at ). My company/organization has various local affiliates acting as MAHs. Do we have to [...] internal staff members as well as to staff members of a consultant company. Please contact us via basg-eservices@basg.gv.at . so that our support can enter data accordingly How can I register my company/organization
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
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