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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
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
note Notification veterinary medicinal products basg-v-phv@basg.gv.at Notification blood and tissue products haemovigilanz@basg.gv.at gewebevigilanz@basg.gv.at [...] electronic notification form veterinary paper form for doctors paper form by e-mail to: basg-v-phv@basg.gv.at by mail to: BASG, 1200 Vienna, Traisengasse 5 Reporting options for blood and tissue products paper [...] e-mail to: haemovigilanz@basg.gv.at gewebevigilanz@basg.gv.at Notification forms (available in German only) Nebenwirkung Arztmeldung Veterinär (F_Z70) | 197 KB 24/07/2018 BASG Meldung unerwünschter Ereignisse
ns. The report is made to the BASG or to the pharmaceutical company who is the marketing authorization holder or distributor of the medicinal product concerned. The BASG accepts the notifications online
signatures, please visit signature verification or submit a request for verification at the BASG ( basg@basg.gv.at ) . Legal basis: Federal Electronic Signature Law - Federal Act on Electronic Signatures [...] Official electronic signature Secured publication of figurative mark of BASG The Federal Office for Safety in Health Care (BASG) uses the following two figurative marks for the electronic signature of
Press Media contact presse-basg@basg.gv.at We are very happy to support you with inquiries from the following areas: Pharmaceuticals (registration, pharmacovigilance, counterfeit drugs) Medical devices
instructions for use are available at: https://www.basg.gv.at/fuer-unternehmen/online-service/nutzungshinweise Endpoint public Internet https://webservices.basg.gv.at/medicineshortage/export/v1/download Endpoint [...] healthcare professionals (yes/no) Rechtsgrundlage_Meldung Legal basis of the notification Hinweis_BASG Important BASG-information (optional) Information of the medicinal product per pack size Zulassungsnummer [...] Endpoint GIN https://webservices-ginet.basg.gv.at/medicineshortage/export/v1/download General information Since February 1, 2018, marketing authorisation holders and their authorised representatives have
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