Medicines and Medical Devices

The AGES Medicines & Medical Devices business segment is responsible for a wide variety of tasks in the licensing of pharmaceuticals, clinical testing of medicines and medical devices, pharmacovigilance and vigilance in the field of medical devices, as well as in the field of inspection. The main client and the owner is the Republic of Austria, represented by the Federal Ministry of Health and Women’s Affairs (BMGF). Medicines & Medicinal Devices employs around 280 staff.
This business segment is certified in line with ISO 9001 and testing activities carried out by the Official Medicines Control Laboratory (OMCL) and inspections are recognised by Accreditation Austria.

The Austrian Federal Office for Safety in Healthcare (BASG), an agency subordinate to the BMGF, has been entrusted with the execution of statutory tasks that fit together with the work of the Medicines & Medicinal Devices segment.

Activities & Head

Portrait of DI Dr.Christa Wirthumer-Hoche

Head of Division

DI Dr. Christa Wirthumer-Hoche
Phone: +43 50 555-36000
Traisengasse 5
1200 Wien

Assistant

Stefanie Rauscher
Phone: +43 50 555-36001
Traisengasse 5
1200 Wien
Portrait of DI Dr.Christa Wirthumer-Hoche

Head of Division

DI Dr. Christa Wirthumer-Hoche
Phone: +43 50 555-36000
Traisengasse 5
1200 Wien

Assistant

Stefanie Rauscher
Phone: +43 50 555-36001
Traisengasse 5
1200 Wien

Activities

•    Scientific consultation
•    Approval of clinical tests
•    Licensing of pharmaceuticals and life cycle management
•    Pharmacoviligance (drug safety)
•    Controlling pharmaceutical quality (before and after licensing)
•    Inspections
•    Supervising and monitoring the pharmaceutical market (advertising, illegal market)
•    Supervising and monitoring the market and medical products
•    Haemovigilance and tissuevigilance
•    Austria’s representative on various pharmaceutical committees (national, EU, international)

Institute

Institute Assessment & Analysis
Institute Surveillance
Institute for Marketing Authorisation of Medicinal Products & Lifecycle Management

Products and Services

Assessment & Analysis

Institute Assessment & Analysis

Head

Dr. Gerhard Beck
Phone: +43 50 555-36300
Traisengasse 5
1200 Wien

Head

Dr. Gerhard Beck
Phone: +43 50 555-36300
Traisengasse 5
1200 Wien

General contact

Assessment

Traisengasse 5, 1200 Wien
Tel.: +43 (0)5 0555 36541
Dr. Barbara Tucek
E-Mail: pharm-vigilanz@ages.at

Tel.: +43 (0)5 0555 36824
Dr. Barbara Zemann
E-Mail: bpsv_biologika@ages.at; bpsv_praeklinik@ages.at; bpsv_statistik_sa@ages.at; bpsv_vete@ages.at; scientificadvice@ages.at

OMCL

Possingergasse 38, 1160 Wien
Tel.: +43 (0)5 0555 36360
DI Heidemarie Schindl
E-Mail: chargen@ages.at

Zimmermanngasse 3, 1090 Wien
Tel.: +43 (0)5 0555 36940
Mag. Roman Macas
E-Mail: basg.cpaa@ages.at uand for matters relating to the ÖAB: basg.oeab@ages.at

Focus

Assessment Centre Traisengasse

  • Professional participation in licensing processes of human and veterinary pharmaceutical
  • Assessment of manufacturing, pre-clinic, statistics and clinical aspects
  • Scientific consultation (national and at European Medicines Agency levels)
  • Systematic supervision and monitoring (pharmacovigilance) of human and veterinary pharmaceuticals
  • Disseminating information such as communications on safety issues

OMCL Possingergasse and Zimmermanngasse

  • Analytical tests and quality appraisals of medicines before licensing, after market launch and as part of batch release 
  • Incident related investigation and assessment of suspicious pharmaceuticals from the illegal drug market.
  • Development and assessment of monographs, methods and reference standards for the European and the Austrian Pharmacopoeia

Surveillance

Institut Überwachung

Head

DI Dr. Ronald Bauer
Phone: +43 50 555-36400
Traisengasse 5
1200 Wien

Assistant

Doris Krenn
Phone: +43 50 555-36401
Traisengasse 5
1200 Wien

Head

DI Dr. Ronald Bauer
Phone: +43 50 555-36400
Traisengasse 5
1200 Wien

Assistant

Doris Krenn
Phone: +43 50 555-36401
Traisengasse 5
1200 Wien

General contact

AGES – Institute Surveillance
Traisengasse 5, 1200 Wien
Phone: +43 (0)5 0555 36402, 36403, 36435
inspektionen@ages.at

Focus

  • Inspection of manufacturers, laboratories and retailers, based on national laws
  • Inspections of and approvals for clinical tests in line with the Austrian Medicines Act (AMG and MPG), the ethics commissions and pharmacovigilance Systems 
  • Provision of import licenses and marketability certificates  
  • Supervising  & monitoring the medicine market for illegal activities  
  • Supervising  & monitoring medicinal products, haemovigilance and tissuevigilance, as well as spontaneous reports of  adverse effects of pharmaceuticals

Authorisation & LCM

Institute Marketing Authorisation of Medicinal Products & Life Cycle

Head

Mag. Dr. Peter Platzer
Phone: +43 50 555-36570
Traisengasse 5
1200 Wien

General contact

Phone: +43 (0)5 0555 36002
Traisengasse 5
1200 Wien

Head

Mag. Dr. Peter Platzer
Phone: +43 50 555-36570
Traisengasse 5
1200 Wien

General contact

Phone: +43 (0)5 0555 36002
Traisengasse 5
1200 Wien

Focus

  • Regulatory processing of all incoming applications in national and European (mutual recognition procedure and decentralised procedure) licensing, amendment and extension procedures
  • Scientific assessment of all human and veterinary drug specialties – excluding biologics – including all procedures (national, mutual recognition procedures, decentralised and centralised procedures) in relation to quality
  • Scientific assessment of all human drug specialities – excluding biologics – in national, mutually recognized procedures and decentralised procedures in relation to the pre-clinical and clinical dossiers and  transfer of procedures requiring a medical expert opinion by the BGA 
  • Classification of quality and manufacturing deficiencies in terms of medicine quality, safety and effectiveness
  • Collaboration in scientific committees at national levels, EMA, European Council
x