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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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any adverse reactions occurring in Austria to the BASG. Patients and their relatives can also report suspected adverse drug reactions directly to the BASG. Medical devices Malfunctions, quality defects or [...] notification to the BASG. Illegal medicines If you have a well-founded suspicion that a drug that you have purchased from a legal source could be a counterfeit or an illegal drug, the BASG is the competent [...] distributors of a medical device, have the opportunity to submit a corresponding notification to the BASG.
further information, please contact basg_anfragen@basg.gv.at . General information The Federal Office for Safety in Health Care (BASG) is not entitled to make individual therapy recommendations . The treatment [...] of the treating physician. The BASG cannot oblige companies to produce or place medicinal products on the market. In order to improve the exchange of information, the BASG publishes a „ Shortages catalouge [...] BASG and consumers Page for patients and consumers Here you can get information about medicinal products and medical devices. Selected topics - easy to understand and transparent. If you require further
y re-evaluate the safety profile of medicinal products and medical devices. For this purpose, the BASG is also in constant exchange of information with other medicines authorities of the European Economic [...] risk, individual product batches can be recalled or warnings issued. Via official notifications, the BASG informs all interest groups at short notice about changes in the safety profile of medicinal products [...] particularly high, the marketing authorisation may also be suspended or withdrawn. Representatives of the BASG participate in Austrian and European committees and working groups, in which these topics are discussed
the CPP, information on the manufacturer, if applicable) as a single document. Contact E-Mail: cpp@basg.gv.at Form: Application for a Certificate for a Pharmaceutical Product (F_M69) | 46 KB 23/07/2019
procedure? No, but the outcome of the PSUSA will be published on the EMA homepage or on the BASG homepage: https://www.basg.gv.at/en/companies/pharmacovigilance/pv-wordings Risk Management Plans (RMP) Which medicinal [...] the BASG website. Is a joint design or sending of DHPC or Educational Material, which refers to an active substance (cross-company) or to a Class Labelling, controlled and coordinated by the BASG? The [...] The cooperation of the companies concerned is supported by the BASG. A coordination by the BASG is not possible. What are the requirements with regard to the distribution list? The companies will certainly
or usage information for use shall apply. For legally binding information, please contact us at basg@basg.gv.at . The Federal Office for Safety in Health Care therefore accepts no liability for the accuracy [...] the Register of Proprietary Medicinal Products and BASG pronouncements Timeliness of the data in the Register of Proprietary Medicinal Products and BASG pronouncements Data is updated over night and the [...] Terms for use Terms of use Data provision www.basg.gv.at and data interfaces (web services) The Federal Office for Safety in Health Care takes great care in providing information on drug specialties, procedure
rms@basg.gv.at For general requests concerning DC- and MR-procedures please contact BASG via: Tel. national: 050 555-36666 Tel. international: +43 (0)50 555-36666 Email: hotline.euregulatory@basg.gv.at [...] State to Austria, a completed CMD(h) request form (Template for RMS change) should be sent to rms@basg.gv.at .The CMD(h) request form can be found in the Download section or on the CMD(h) website . This
leaflets for all medicinal products authorised in Austria in the Austrian Medicinal Product Index of the BASG. Please consult your doctor if you notice that you should not take the prescribed medicine because
from human cells and tissues can be found at www.basg.gv.at/gesundheitsberufe/gewebesicherheit , www.basg.gv.at/gesundheitsberufe/blutsicherheit und www.basg.gv.at/fuer-unternehmen/bewilligung-und-zertif [...] guideline is not legally binding. Binding information requires a separate request (to ATMP-leitfaden@basg.gv.at ) and can only be provided for specific cases after thorough examination of all information
eu or georg.neuwirther@ages.at respectively nat@basg.gv.at for national applications, rms@basg.gv.at for applications where AT acts as RMS and basg-cms@basg.gv.at for applications where AT acts as CMS. CESP [...] neuwirther@ages.at or our functional e-mail addresses (nat@basg.gv.at for national applications, rms@basg.gv.at for applications with AT=RMS and basg-cms@basg.gv.at for applications with AT=CMS). [...] specific CESP submissions, please contact cesp@basg.gv.at . Further information on CESP can be found at the HMA . eCTD/VNees When switching to the eCTD format , the BASG recommends that at least Module 3 be submitted