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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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BASG and companies News Information The new Veterinary Medicinal Products Regulation is to be applied as of 28.01.2022, further information can be found here: The new Veterinary Medicinal Products Regulation [...] is to be applied as of 28.01.2022, further information can be found here: read more Reporting to BASG The Federal Office relies on reports from consumers, health care professionals and companies for the [...] continuous re-evaluation of the safety profile of medicinal products and medical devices. Reporting to BASG read more BREXIT The transition period ended on 31.12.2020. Marketing authorisation holders are reminded
Product Index of the BASG under "Domain"/"Veterinary". You can report suspected side effects of veterinary medicinal products directly to the Federal Office for Safety in Health Care (BASG), Department HEVE [...] HEVE (Herbal, Homeopathic and Veterinary Medicinal Products): basg-v-phv@basg.gv.at
Apothekenbetrieben (in German only) Form: delineation tool (F_I268) | 63 KB 23/12/2009 side lettter of BASG to delineation tool | 802 KB 21/12/2009
manufacturer's recommendations into account. No special calibration intervals are prescribed by the BASG. During inspections, however, the justification for the periodic functional tests and the suitability [...] brought to the attention of the Ethics Committee before they take up their duties. Information to the BASG is only required if contents of the EudraCT notification form are concerned. This notification can
Austrian Medicinal Product Index (all medicinal products regardless of the authorisation date) and BASG-Announcement (recently authorised medicinal products) If the final classification of the prescription
Off-Label Use The BASG, the ÖGARI and the Austrian Patient Ombudsman have agreed on the following wording on the subject of off-label use. “Off-label use" refers to the use of a drug in the context of
violations of the relevant legislation. On behalf of the Federal Office for Safety in Health Care (BASG), the Enforcement Team handles all suspected cases of illegalities in the areas of the Medicines Act [...] laypersons, or to promise unrealistic treatment success, etc. If these requirements are exceeded, the BASG Medical Market Surveillance initiates detailed surveys. Execution and Prevention The primary objective [...] medicine bought from a legal source could be a counterfeit or illegal, this should be reported to BASG. A suspicion could, for example, be based on an unusual colour of the tablets, a different efficacy
the following link: https://medprodabgabe.basg.gv.at The self-declaration must be submitted in electronic form via the web form (link: https://medprodabgabe.basg.gv.at) . You will receive an RsB letter from [...] device - they fall neither under the Medical Devices Levy Ordinance nor under the jurisdiction of the BASG. General Independent of the registration in the medical device register, every natural or legal person [...] medical device levy has changed as of 1/1/2019: Click on the following URL: https://medprodabgabe.basg.gv.at Enter your identifier and password. You received your ID and password with the information letter
Medicinal Product Index Pharmaceutical companies Register of retailers Internet pharmacies BASG official announcement BASG voting results Reporting Human adverse reaction notification Veterinary Adverse Event [...] monographs for comments Archive of monographs Archive of deleted monographs CHMP Meeting Highlights-BASG The CHMP introduces itself For Companies Online services Login online services Reporting adverse reactions [...] (PSURs) FAQ pharmacovigilance Guideline pharmacovigilance Medicinal products Scientific advice by BASG Quality of medicines Medicines for children Plasma derived products Batch release Recombinant proteins
current supply situation of certain radiopharmaceuticals, the Federal Office for Safety in Health Care (BASG)/AGES PharmMed draws attention to particularities in the use of unauthorised medicinal products,