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".
a product on the market may submit an application to the Federal Office for Safety in Health Care (BASG) to determine whether this product falls within the definition of a medicinal product or a veterinary [...] documents. Within the scope of this procedure, pursuant to Section 1 (3b) AMG or Section 2 (5) TAMG, the BASG may obtain an expert opinion of the Delineation Commission pursuant to Section 49a AMG or Section [...] Alternatively, persons wishing to place a product on the market can submit an informal enquiry to BASG by e-mail , which is answered by e-mail without a formal expert opinion and without notification.
datenschutz@basg.gv.at Dunning activities, due dates basg.mahnungen@basg.gv.at DHPC and education material dhpc-em@basg.gv.at eAF - regulatory questions basg-cms@basg.gv.at eAF general topics basg-eservices@basg [...] euregulatory@basg.gv.at eServices - technical issues basg-eservices@basg.gv.at Fee and invoice issues basg.fakturierung@basg.gv.at Free Sales Certificate for medical devices fsc@basg.gv.at GLP Good Laboratory [...] Laboratory Practice glp@basg.gv.at Haemovigilance haemoviglianz@basg.gv.at Herbal medicines basg-heve@basg.gv.at Homeopathic medicines basg-heve@basg.gv.at Infrastruktursicherungsbeitrag (ISB) infrastruktursic
under the registration number 09282/0. By granting this certification, Quality Austria confirms that BASG and the Austrian Medicines and Medical Devices Agency operate in accordance with and continues to
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 particularly high, the marketing authorisation may also be suspended or withdrawn.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
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
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.
Referenced at: