Medicines and Medical Devices

The AGES Medicines and Medical Devices Agency is responsible for the licensing, and supervision and monitoring of pharmaceuticals and medicinal products. The agency, which was formerly part of the Federal Ministry of Health and Women’s Affairs, was integrated into AGES under the name PharmMed on 01.01.2006. The division was renamed AGES Medicines and Medical Devices Agency once its efficiency-oriented business concept came into effect in 2012. While AGES is mainly financed through federal funding, the budget for the Austrian Medicine and Medical Devices Agency comes mostly from fees paid by companies for license applications and/or applications for license changes and alterations.

A new tariff system came into effect three weeks after the former AGES PharmMed began its work. The Federal Office for Safety in Health Care (BASG) was founded together with the current Agency for Medicine and Medical Devices. While the Austrian Medicine and Medical Devices Agency and its three institutes cover the operational agendas for all its fields of responsibility, the BASG carries out all official tasks in the field of the testing and licensing of medicines and medical products and is an authority subordinate to the Austrian Federal Ministry of Health. AGES’s medicines and medical devices segment is closely linked to the BASG in organisational matters. It provides the federal agency with services, staff and facilities.

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 of Institute

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

Head of Institute

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 of Institute

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 of Institute

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
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