Health for humans, animals & plants

AGES Medical Market Surveillance

Our three institutes ensure that only safe and effective medicinal products and medical devices are available to the population in Austria, but also throughout Europe. To this end, we perform a wide range of tasks in connection with drug approval, clinical testing of drugs and medical devices, pharmacovigilance (drug safety), vigilance in the field of medical devices, and inspections.

The Federal Office for Safety in Health Care (BASG), a subordinate authority of the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK), is entrusted with the execution of the sovereign tasks that coincide with our work.

14.812
nationally approved/registered drugs
474
Inspection procedure
3.955
Batch testing of plasma products & vaccines
Christa Wirthumer-Hoche

We ensure that high-quality, effective and safe medicines are available in Austria.

DI Dr. Christa Wirthumer-Hoche, Leitung

Our tasks

  • Scientific advice in the context of drug development
  • Approval of clinical trials of drugs and medical devices
  • Evaluation of quality, safety and efficacy of drugs in the context of marketing authorization and life cycle management
  • Monitoring of adverse drug reactions for continuous control and improvement of drug safety (pharmacovigilance)
  • Analytical monitoring of drug quality through laboratory controls
  • Inspection system within the scope of manufacturing, preclinical and clinical testing, distribution as well as vigilance
  • Monitoring of the pharmaceutical market with regard to legal and illegal promotional activities, marketing and Internet sales
  • Monitoring of the market and safety of medical devices as well as blood and tissue products
  • Monitoring of the supply situation of medicinal products
  • Official Medicines Control Laboratory (OMCL)
  • Collaboration in the editing of the European Pharmacopoeia (German language edition)
  • Participation in national and international committees
  • Research
  • Method development

Our institutes

Assessment & Analytics

Our focus

  • Scientific evaluation of medicinal products for human use in centralized marketing authorization procedures and scientific advice
  • Scientific evaluation of pharmacovigilance data of medicinal products for human use with regard to benefit/risk and determination of risk minimizing measures
  • Batch testing of plasma products and vaccines
  • Drug market monitoring

Surveillance

Our focus

  • Inspection of manufacturers and distributors of medicinal products as well as control laboratories and issuance of GM/DP certificates
  • Inspection of tissue establishments
  • Monitoring of narcotics management
  • Inspection of preclinical testing facilities
  • Inspection of pharmacovigilance systems
  • Inspection and approval of clinical trials according to AMG and MPG, as well as inspection of ethics committees
  • Monitoring of remote sales
  • Approval of compassionate use programs
  • Evaluation of reports of adverse drug reactions
  • Evaluation of quality defects and distribution restrictions
  • Implementation of medical device, haemo- and tissue vigilance
  • Conducting market surveillance for medical devices including inspection
  • Issuing free trade certificates for medical devices
  • Issuance of import and marketability certificates according to the Pharmaceutical Products Import Act
  • Evaluation of shipment notifications according to the Medicinal Products Import Act
  • Monitoring of the medical market with regard to illegal activities

Institute for Marketing Authorisation of Medicinal Products & Lifecycle Management

Our focus

  • Scientific evaluation of marketing authorization procedures for human medicinal products with regard to quality, safety and efficacy
  • Scientific evaluation of marketing authorization procedures for veterinary medicinal products with regard to quality, safety, residues and efficacy
  • Scientific-technical evaluation of amendment procedures of human and veterinary medicinal products
  • Scientific evaluation of pharmacovigilance data of veterinary medicinal products
  • Classification of quality and manufacturing defects with regard to drug quality, safety and efficacy
  • Participation in national and international committees

Contact

Leitung

DI Dr. Christa Wirthumer-Hoche

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Allgemeine Kontaktadressen zu den Leistungen des Geschäftsfeldes finden Sie auf der Website des BASG

Last updated: 15.02.2022

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