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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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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 "
ance Union Product Database (UPD) Notification of pet products National Legislation / Information BASG talk NVR
C3%A4ufig-gestellte-Fragen-zum-Thema-Impfungen.html Does BASG provide individual vaccination advice? No. As the official Medicines Agency, BASG can merely provide information about which vaccines MAY be [...] FAQ Vaccines Frequently asked questions about vaccinations - Federal Ministry of Health Does BASG provide individual vaccination advice? Which studies and controls have to be performed before vaccines
datenschutz@basg.gv.at . The legal framework is laid down in the Health and Food Safety Act (GESG), Federal Law Gazette I No. 63/2002 as amended. In fulfilment of its statutory duties, the BASG is entitled [...] to the processing of personal data: a. Legal basis The tasks of the BASG are defined in § 6a GESG. In fulfilling these tasks, the BASG is entitled to process personal data pursuant to § 9 para 7 GESG. In [...] ing provisions authorising the BASG to pass on personal data can be found in the relevant material laws (e.g. Section 80 of the Medicines Act). 4. Data security The BASG provides for technical and org
parties whose activities are regulated by the material laws under the jurisdiction of the BASG. The services of the BASG are available to all applicants and notifiers who are entitled under the material laws [...] Section 82a of the German Medicines Act (AMG), all employees of the BASG and the AGES MEA are obliged to submit annual declarations to the BASG regarding any grounds for bias. The criteria used for the evaluation [...] Safety Act (GESG) with the execution of the tasks of the Federal Office for Safety in Health Care (BASG). Pursuant to § 8 (7) GESG, the acceptance of third party contracts is prohibited for this business
Legal ordinances of BASG BASG on electronic transmission of applications and notifications (German only) Ordinance of the BASG on the electronic transmission of applications and notifications (Electronic [...] medical devices (German only) Ordinance of the BASG on fees for medical devices, version 30.07.2022 | 75 KB 01/08/2022 BASG on official badge (German only) BASG communication on official badges, version 30 [...] Ordinance of the BASG on the electronic transmission of applications and notifications (Electronic Ordinance on Submissions 2011 - EEVO 2011) version 30.07.2022 | 58 KB 01/08/2022 Ordinance of the BASG on the
BASG publications After the decision has been made, the results of the BASG votes and the issued notices of the BASG are entered in the list in an electronic release process. BASG announcements listed [...] listed on a daily basis. From the foundation of the BASG on 01.01.2006 to 19.06.2013, voting took place by circulation. The agendas, votes and announcements from this period can be found in the subordinate pages [...] pages. The Rules of Procedure of the BASG applies to the procedure of the Federal Office for Safety in Health Care as amended. The Annex to the Rules of Procedure establishes the authorisation to issue
BASG approval procedure Since 2013: After the decision has been made, the results of the BASG votes are listed in an electronic release process updated daily. Voting archive 2012-2013 BASG Abstimmungen
professionals electronic form human Paper form human paper form human by e-mail pharm-vigilanz@basg.gv.at by post BASG, 1200 Wien, Traisengasse 5 by fax + 43 (0) 50 555 36207 telephone support: + 43 (0) 50 555 [...] Industry Regulation Act 1994), are obliged to report adverse drug reactions occurring in Austria to the BASG pursuant to the Arzneimittelgesetz (Medicinal Products Act) and the Pharmacovigilance Ordinance ( [...] relatives also have the option of voluntarily reporting suspected adverse drug reactions directly to the BASG. Statistics of all reports, broken down by first and subsequent reports as well as by notifier can
wholesaler with the BASG. Under " Internet pharmacies " you will find the Internet pharmacies registered in Austria. All BASG decisions since 31.07.2013 are listed under BASG announcements and BASG votes (for previous [...] for use (package insert), the summary of product characteristics for health professionals, and the BASG assessment report on this product. The Medicine Shortages Catalogue presents all reported procedures [...] those proprietary medicinal products which have been banned from parallel export after review by the BASG. The Register of pharmaceutical companies authorised according to §63 AMG contains all establishments