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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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AT). The BASG has to decide within 45 days after receipt of an application. After completion of the assessment, a corresponding decision will be issued. Please address any questions to qrd@basg.gv.at . [...] contact inspektionen@basg.gv.at . Downloads Guideline Exemptions AMG (L_Z173) | 328 KB 29/05/2024 Form Exemption Request §16/17 AMG (F_Z90) | 47 KB 29/05/2024 Further inquiry note qrd@basg.gv.at [...] Medicinal Product Index According to Art 27 AMG the Austrian Medicinal Product Index is published by BASG (Federal Office for Safety in Health Care) where defined data of all authorised and registered medicinal
should be made in writing and submitted to the address of BASG, Traisengasse 5 in 1200 Vienna, or by e-mail to the address recht@basg.gv.at . The BASG can then either issue a preliminary decision on the complaint [...] 8/2022 . The competent authority in terms of the CTR is the Federal Office for Safety in Health Care (BASG). Ethics Committees acting under the CTR are organised in a national platform and published on the [...] Committee for the Province of Salzburg the Ethics Committee of the Medical University of Vienna The BASG and the platform of Ethics Committees will define the details of their cooperation in an agreement
Tasks and Activities Tasks of BASG according to GESG Activities of BASG Tasks of BASG according to GESG Pursuant to Gesundheits- und Ernährungssicherheitsgesetz ( GESG ) § 6a. (1) The Federal Office for [...] Safety in Health Care gives scientific advice on the development of medicinal products. Activities of BASG Scientific Advice Admission of Clinical Trials Marketing Authorisation and Lifecycle Management of [...] Market Surveillance und Vigilance of Medical Devices Haemovigilance and Tissuevigilance Form: Process BASG (L A120) | 154 KB 20/03/2020
Reports and Facts Folder For resource reasons, replacing past practice of bilingual annual reports, BASG started in 2021 to publish an annual „Facts Folder“ in english only, aiming particularly at international
Statistics BASG statistics about medicinal products and medical devices Several statistics about authorisation, analyses, inspections and surveillance of medicinal products and medical devices are generated [...] generated by the BASG and published in its annual reports . From 2006 until 2015 those reports were prepared annually - since 2016 they are prepared every two years and all previous editions are published [...] ion procedures for medicinal products for human use, which you can find on the CMDh website . The BASG furthermore publishes the so-called RMS Flyer which inform about Austria's very successful activities
Health Care publishes annual reports and folders on selected topics. Scientific publications involving BASG staff are listed. Annual Reports and Facts Folder Folder Scientific Publications
templates for PDF with unlimited access (PDF/UA) The BASG has updated the accessible versions, which are available for download at https://www.basg.gv.at/en/companies/marketing-authorisation-life-cycl [...] information please refer to Accessible patient information leaflet - BASG , resp. FAQ Accessible patient information leaflet - BASG . CMDv - call for early submission and statistics Please find the call [...] SmPC, package leaflet and labelling . For further information please refer to FAQ online services - BASG . Based on the final package leaflet , an accessible PDF document has to be created and also uploaded
general cover letter, must be submitted to the BASG via the Common European Submission Portal (CESP). Before or at the same time as the application to the BASG, the application for approval of the clinical [...] competent authority of the Member State in which the clinical trial is to be conducted. In Austria, the BASG is the competent authority for this purpose. Irrespective of this, the application for approval of [...] ion Before the start of each clinical trial, an application for approval must be submitted to the BASG. The documents required for proper submission are listed in the appendix of the application form "
in Health Care (BASG) AGES Austrian Medicines and Medical Devices Agency Traisengasse 5 A-1200 Vienna Tel. national: 050 555-36111 Tel. international: +43 (0)50 555-36111 E-Mail: basg@basg.gv.at Responsible: [...] MDRA (Member of the BASG responsible for the procedure and Head of the AGES Austrian Medicines and Medical Devices Agency) Internet editorial office: E-mail: redaktion-basg@basg.gv.at Disclosure pursuant [...] the website, please contact redaktion-basg@basg.gv.at . Disclaimer Here you can find our privacy policy . Editorial content management, conception & specification: BASG / AGES Austrian Medicines and Medical
ges.at Enquiries (for media): Communications Management, Tel.: +43 505 55-25000 E-mail: presse-basg@basg.gv.at [...] reactions during #MedSafetyWeek: November 6-12, 2023. The Federal Office for Safety in Health Care (BASG) is taking part in the global social media campaign called #MedSafetyWeek to raise public awareness [...] therefore make a significant contribution to ensuring that medicines are safer for everyone and that the BASG (Federal Office for Safety in Health Care) can protect public health even better through effective