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
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
Medicinal products Scientific advice by BASG Quality of medicines Medicines for children Plasma derived products Batch release Recombinant proteins Forms for medicinal products Controlled substances R
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
CHMP Meeting Highlights-BASG Austrian members of the CHMP report on meeting highlights concerning centralised procedures: recommendations for approval, extensions of therapeutic indication, newly published
BASG and healthcare professionals News Information Shortages Based on reports from pharmaceutical companies, BASG informs about current shortages. Shortages read more Reporting to BASG The Federal Office [...] continuous re-evaluation of the safety profile of medicinal products and medical devices. Reporting to BASG read more Register of authorised medicinal products The medicinal products database contains all products
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