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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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Office for Safety in Health Care (BASG) about the rejection and the reasons for it. The applicant receives the objection in written form. The applicant may request the BASG to revise the decision to reject [...] ion holder in Austria on the market. The Austrian OMCL is the medicines control laboratory of the BASG. For plasma products that are licensed in Austria, also batch release certificates from other OMCLs [...] reject the batch. This has to be done by BASG within 30 days. Requests for further data (including analytical test results) prolong the deadline. The rejection of a batch has to be reported to the European
responsibility of the Federal Office. For this purpose the procedures and rules of EMA shall apply. For BASG FAQs click here . For FAQs, related documents and further information of the EMA click here . Please
Scientific advice by BASG Scientific advice in the development of medicinal products The objective of such national scientific advices is to discuss with BASG scientific matters regarding the development [...] general, scientific advices are held as online meetings, which will be hosted and organised by the BASG. Alternatively, a face to face meeting or written scientific advices can be selected by the applicant [...] Procedure The applicant submits the fill-out application form with the questions to scientificadvice @basg.gv.at The validation of the application is performed within four working days. The applicant receives
non-interventional studies to the BASG. changes to ongoing non-interventional studies end-of-study notifications and final reports no longer have to be submitted to the BASG. This general rule is also applicable [...] also do not require a notification to the BASG. Restrospective data evaluations do not count as clinical studies and do not require a notification to the BASG. The linking of non-interventional studies [...] discontinued with immediate effect. Guideline for differentiation from other studies The BMSGPK and BASG have jointly prepared a guideline on the differentiation of clinical studies - clinical trials and
Safety in Health Care (BASG) is responsible for processing applications and handling notifications within the scope of the AWEG. Certificate of a pharmaceutical product (CPP) BASG issues certificates of
accessed here. Please note that organisations have to register with the BASG before first using the web portal. During registration, the BASG will check whether the registering organisation is authorised to submit [...] medicinal product have to be notified to the BASG if it is shipped from another Member State? For a centrally approved medicinal speciality, no notification to the BASG is necessary for shipments from another [...] must be made before the products are brought into Austria, and the BASG must be informed at the same time as the notification. The BASG reacts immediately and informs in writing whether there is an ob-jection
Nr. 79/2010, must be done electronically. Applications and notifications can be submitted via the BASG online service platform. Detailed information is available in the FAQs . subject links registration [...] terms 'medicinal product' and 'blood product'. The Austrian Federal Office for Safety in Health Care (BASG) is responsible for processing applications and handling notifications within the scope of the AWEG [...] contracting parties of the European Economic Area (EEA) (shipment according to § 2 lit. 5 AWEG). The BASG is authorized to inspect the entire process of shipment and import by requesting documents or by on-site
section. The BASG Templates for Human Medicinal products were adapted to the current version of the EMA QRD Templates in July 2020 and slightly revised. Furthermore, in May 2022, the BASG templates for [...] that changes can be tracked, the previous versions of the BASG templates are still available in the Downloads section. These documents offered by BASG are intended to serve as support and can be used on a [...] services Initial situation In an arbitration process, the Federal Office for Safety in Health Care (BASG) was obliged according to § 14 of the Federal Disability Equality Act (BGStG) to request Holders of