What's new
Newsletters "UptoDate" of BASG/AGES MEA are published monthly and contain the latest articles from the last month (link to subscription page).
For the RSS feed with daily notification of updates, use the link: RSS feed to "what's new".
Search narrowed by
to the BASG, but served as an example of an internal hospital template. If you need it for internal forwarding to your hospital blood bank, please feel free to request it at haemovigilanz@basg.gv.at. (The [...] All haemovigilance notifications must be submitted to the Federal Office for Safety in Health Care (BASG) via the eService "Haemovigilance and Tissue Vigilance". Thema Links Guidance notes Online Services [...] submission (The online reporting is only available in German.) Further inquiry note haemovigilanz@basg.gv.at Emergency Phone Number (24-Hours):: +43 (0)664 831 28 43 Fax: +43 (0)50 555-36408 Annual report
Austrian Medicines Act, Federal Law Gazette I No. 23/2020, only apply to clinical trials submitted to the BASG before 31 January 2023. As of 31 January 2023, initial applications for approval of clinical trials [...] trials (SUSAR and DSUR) can be found here . The current fees for clinical trials can be found in the BASG ordinance on fees . Changes to the EudraCT database No EudraCT functionality will be modified. There
products also have to be reported? How long does the BASG have time to publish a not available or limited available medicinal product? How does the BASG check whether a parallel export ban is applicable? [...] medicines must be reported. How long does the BASG have time to publish a not available or limited available medicinal product? The processing within the BASG business hours shall always be carried out [...] are always published in the public catalogues after successful processing by the BASG on the day after. How does the BASG check whether a parallel export ban is applicable? The review is carried out using
at the top left of the homepage. The languages German and English are available. The links to the "BASG announcements", the FAQ and the terms of use/download can be found in the top right-hand corner. Below
reporting obligation regarding serious adverse events according to the AMG must be submitted to the BASG in advance. Forms Form: SUSAR Waiver (F_I437) | 62 KB Request for waiver for direct reporting of SUSARs [...] Update Report (DSUR)". For further details, please refer to Section 8 of the CT-3 Guideline and the BASG FAQ on this subject.
on of receipt will be sent from the BASG system PHAROS to the applicant. Confirmations of receipt from the e-mail system do not apply here. From this date the BASG will confirm that the notification is [...] Clinical investigations with medical devices Electronic Submission Form of the BASG General requirements for applications (technical validation) Clinical investigations according to Regulation (EU) 2017/745 [...] studies according to Directives 90/385/EEC, 93/42/EEC and 98/79/EC Electronic Submission Form of the BASG The electronic registration form is mandatory for a valid initial application a clinical investigation
ongoing procedures please contact for RMS applications rms@basg.gv.at for CMS applications basg-cms@basg.gv.at for purely national applications nat@basg.gv.at [...] to cesp@basg.gv.at, but not the accessible PDF/UA documents. These must be uploaded by the applicant in the eService after creation of the respective procedure(s) by the BASG. 3. Does the BASG check the [...] documents providing for accessibility were prepared by the BASG and can be found here on the website of the BASG. 8. Is it allowed to deviate from the BASG Templates and use a different font? You are free to
and, with this knowledge, actively supports applicants in the approval of their medicinal products. BASG actively invests in the know-how of its employees. Regular training and networking opportunities at [...] informs the RMS if the new CMS require a renewal Please submit such requests with AT as RMS to rms@basg.gv.at . Information about the respective fee can be found in the currently valid regulation of fees
contact in Austria in order to register for the eService "Authorisation and Lifecycle MP"? Does the BASG/AGES Medizinmarktaufsicht contact me via the eService"Authorisation and Lifecycle MP" to discuss my [...] the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG)/AGES Austrian Medicines and Medical Devices Agency (AGES Medizinmarktaufsicht) in procedures for [...] ly, the administrator of the organisation will receive a document containing the access data. The BASG/AGES Medizinmarktaufsicht allows you to appoint one administrator per organisation. The administrator
only the receipt by the BASG is confirmed. There is not authorisation and no publication on the BASG website. The notification should be made by e-mail to clinicaltrials@basg.gv.at . "COVID-19" and "urgent [...] results The introduction of Remote SDV always requires a substantial amendment to be approved by the BASG. The introduction must already be mentioned in the cover letter. In addition to the justification [...] continued supply of trial medication needs to be maintained at home and shipment via pharmacies (see BASG FAQ ) is not possible, the sponsor may organise for trial medication also to be shipped directly from