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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
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
violations of the relevant legislation. On behalf of the Federal Office for Safety in Health Care (BASG), the Enforcement Team handles all suspected cases of illegalities in the areas of the Medicines Act [...] laypersons, or to promise unrealistic treatment success, etc. If these requirements are exceeded, the BASG Medical Market Surveillance initiates detailed surveys. Execution and Prevention The primary objective [...] medicine bought from a legal source could be a counterfeit or illegal, this should be reported to BASG. A suspicion could, for example, be based on an unusual colour of the tablets, a different efficacy
the following link: https://medprodabgabe.basg.gv.at The self-declaration must be submitted in electronic form via the web form (link: https://medprodabgabe.basg.gv.at) . You will receive an RsB letter from [...] device - they fall neither under the Medical Devices Levy Ordinance nor under the jurisdiction of the BASG. General Independent of the registration in the medical device register, every natural or legal person [...] medical device levy has changed as of 1/1/2019: Click on the following URL: https://medprodabgabe.basg.gv.at Enter your identifier and password. You received your ID and password with the information letter
save target as) 2. Open and fill in with Adobe Acrobat* 3. Send .xml and .pdf file to medizinprodukte@basg.gv.at * Adobe Acrobat Pro is required to edit the form 07/02/2024 MIR Helptext for reporting of serious [...] field safety information (FSN) in German and schedule for completing the FSCA to medizinprodukte@basg.gv.at 08/03/2024 Mandatory reporting for healthcare facilities and healthcare professionals Professionals [...] safety officers of hospitals, must immediately report to the Federal Office for Safety in Health Care (BASG) any serious incidents of which they become aware as a result of their professional activities. The