How to contact us

Emergency Contact Number +43 (0) 664 831 28 43

Please note: The emergency number should only be used for emergencies according to art. 70 Medical Devices Act or for emergencies within the meaning of art. 10 Pharmacovigilance Regulation. An emergency is considered to be an immediate danger to life or a serious and substantial threat to health.

All other questions can be adressed to other contact points listed here on this page.

 

24-hour emergency telephone service for pharmacogivilance responsible persons and for safety officers for medical devices.
Tel.: +43 (0) 664 831 28 43

  

Notes on enquiries

  • Prior to contacting us, please visit our website for detailed information, e.g.  Frequently Asked Questions (FAQs) section, as we may have answered your question already.
  • E-mail inquiries should use functional E-mail addresses listed below, so a quick answer is guaranteed even in the case of absences of individual employees.
  • For specific or urgent issues topics and personal contact please use email adressed  with forename.surname@ages.at 

 

AGES MEA is not in charge for following topics:

 

  • BASG or AGES MEA does not make any individual therapy recommendations. The treatment and the treatment regime is determined by the physician individually for the patient and subject solely the responsibility of the treating physician.
  • Reimbursement of medicines fall within the competence of Hauptverband der österreichischen Sozialversicherungsträger.

 Media Related Contacts

The AGES  Public Relations Division deals with all media enquiries relating activities including press releases, press articles and interviews.     

presseagesat+43 (0) 50 555 -25000

 

For specific topics on BASG and AGES MEA:

Dr. Christoph Baumgärtelchristoph.baumgaertel@ages.at+43 (0) 50555-36004

Functional E-Mail Addresses

SubjectE-Mail
Active Substance Master File (ASMF, EDMF)asmf@ages.at
Analytics - chemical-pharmaceuticalbasg.cpaaagesat
Analytics - biological (batch releases)chargen@ages.at
Biologicsbpsv_biologika@ages.at
Boderline and classification issuesabgrenzung@ages.at
Centralised Procedures (Scientific Office)scio@ages.at
Certificate of a Pharmaceutical Productcpp@ages.at
CESP - technical issuescesp@ages.at
Clinical trials on medicinal productsclinicaltrials@ages.at
Clinical trials on medical devices inspektionenagesat
Compassionate usecompassionate-use@ages.at
Dunning activities, due datesbasg.mahnungenagesat
DHCP and implementationpv-implementation@ages.at
Electronic submission (inquiries)eSubmissionagesat
Enforcementenforcement@basg.gv.at
eServices - technical issues basg-eservices@ages.at
Fee and invoice issuesbasg.fakturierung@ages.at
Free Sales Certificate for medical devicesfsc@ages.at
Haemovigilancehaemoviglianz@ages.at
Innovative medicinal productsinnovation@ages.at
Inquiries (general)basg_anfragen@ages.at
Inspectionsinspektionen@ages.at
Inspections of bioequivalence studiesgcp-beagesat
Inspections according to GLPglpagesat
Medical devicesmedizinproduktebasg.gvat
Naming AT=RMSrms@ages.at
Naming AT=CMShotline.euregulatory@ages.at
National Scientific Advice (NASA)scientificadvice@ages.at
Non-interventional studies (NIS)nis@ages.at
Paediatric worksharing Art 45 and 46kinderarzneimittel@ages.at
Parallel importreference@ages.at
Pharmacovigilance - humanpharm-vigilanz@ages.at
Pharmacovigilance - veterinary basg-v-phv@ages.at
Pharmacovigilance implementationpv-implementation@ages.at
Pipeline meeting - contactbasg-agesmedizinmarktaufsichtagesat
Praise or criticismlob_und_tadel@ages .at
PSUR and MRPCASE_PHV@ages.at
Public Relationspresse@ages.at
QRD inquiriesqrd@ages .at
Quality deficiency reportsam-qualitaetsmangel@ages.at
Quality management of the Austrian Medicines and Medical Devices Agencyqmgt@ages.at
Reference product AT=RMSrms@ages.at
Regulatory, general inquirieshotline.euregulatory@ages.at
Regulatory, product-related AT=RMS rms@ages.at
Regulatory, product-related AT=CMSbasg-cms@ages.at
Regulatory, product-related, national in ATnat@ages.at
Regulatory issues - central procedurecp@ages.at
Scientific Advicescientificadvice@ages.at
Side effects - reporting on human medicinesnebenwirkung@ages.at
Sunset clausee-Service-Portal
Supply shortagesam-qualitaetsmangel@ages.at
Tissue-vigilancegewebevigilanzagesat
Veterinary medicines - assessmentbasg-heveagesat

BASG and AGES MEA

BASG - Federal Office for Safety in Health Care

Head of the Office:

Mag. iur. Thomas Reichhart

AGES MEA - Austrian Medicines and Medical Devices Agency

Head of AGES MEA:

Dipl.-Ing. Dr. Christa Wirthumer-Hoche

 

Traisengasse 5, 1200 Wien

 

 

Institutes of AGES MEA:

 

Head
Institute Marketing Authorisation of Medicinal Products & Lifecycle ManagementMag. Dr. Peter Platzer
Institute Assessment & AnalyticsDr. Gerhard Beck
Institute SurveillanceDipl.-Ing. Dr. Ronald Bauer

Institute Marketing Authorisation of Medicinal Products & Lifecycle Management (LCM)

Head: Mag. Dr. Peter Platzer

 

lcmagesat

Traisengasse 5, 1200 Wien

Regulatory issues

 

General enquiries:hotline.euregulatoryagesat
Regulatory, product-related AT=RMS:rmsagesat
Regulatory, product-related AT=CMS:basg-cmsagesat
Regulatory, product-related, national in AT:natagesat

 

 

For MRP/DCP, please see also the list of Austrian contact points  at the CMDh website. 

 



Allocation scheme Neu

Individual regulatory contact persons:

 

 

Quality Assessment of Human and Veterinary Medicinal Products (chemical and defined biological Medicinal Products*)

DI Susanne Stotter susanne.stotteragesat
DI Dr. Wolfgang Herzogwolfgang.herzogagesat



* such as Heparins, low molecular Heparins, Insulin, Pancreatin, Menotrophin, Botulinum toxin, Hyaluroidase, enzyme/Lysate of microorganism, Lactobacillus spp., Streptococcus spp., Phospholipids bovine/porcine (see also CMDh Overview of biological active substances of non-recombinant origin)

 

 

Quality and Medical assessment of Herbal and Homeopathic Medicinal Products in Department HEVE

Univ.-Doz. Dr. Reinhard Länger reinhard.laengeragesat
Dr. Astrid Obmannastrid.obmannagesat

 



 

Medical Assessment of national, MRP and DCP procedures for human medicinal products (except Biologics, Herbals) in Department MRAT

 

Dr. Ingeborg Gerngross ingeborg.gerngrossagesat
Dr. Jascha Hörnischjascha.hoernischagesat

Medical Assessment of national, MRP and DCP procedures for veterinary medicinal products  in Department HEVE   

 

Dr. Gabriele Rothmüller gabriele.rothmuelleragesat
Mag. Ingrid Langner ingrid.langneragesat

Institute Assessment & Analytics (BGA)

Head: Dr. Gerhard Beck

 

chargenagesat

Assessment - Traisengasse 5, 1200 Wien


Medical assessment of human medices in Department CASE 

 

Dr. Barbara Tucek barbara.tucekagesat
Dr. Jan Neuhauserjan.neuhauseragesat

 

Centralised procedures 
 

Dr. Jan Neuhauserjan.neuhauseragesat

  
Biologicals (national, MRP-/DCP-, and centralised procedures)

 

Dr. Brigitte Müllerbrigitte.muelleragesat

 

Pharmacovigilance

 

Dr. Barbara Tucekpharm-vigilanzagesat

 

Biologicals, preclinical assessment, statistics, and veterinary medicines in centralised procedure

 

Dr. Barbara Zemannbarbara.zemannagesat

 

 


OMCL Laboratory - Possingergasse 38, 1160 Wien

 

Analytics biological medicines 

 

Dipl.-Ing. Heidemarie Schindlchargenagesat

OMCL Laboratory - Zimmermanngasse 3, 1090 Wien

 

Analytics  chemical-pharmaceutical medicines

 

Mag. Roman Macasbasg.cpaaagesat
Austrian Pharmacopoeiabasg.oeabagesat

Institute Surveillance (INS)

Head: Dipl.- Ing. Dr. Ronald Bauer

 

 

inspektionenagesat

Traisengasse 5, 1200 Wien

Departments for 

 

GMP/GDPMag. Andreas Kraßnigg
Clinical trials Dr. Ilona Reischl
Medical Devices Market Surveillance 
Mag. Dr. Reinhard Berger
Blood, Tissue & VigilanceMag. Dr. Verena Plattner

Pharmacovigilance contacts

 

Reports: 

 

Single case and signal detection of human medicines

 

Mag. Katharina Weberpharm-vigilanzagesat
Fax.Nr.: +43 (0)50 555 36207

 

Pharmacovigilance veterinary medicines

 

Mag. Brigitte Hauserbasg-v-phvagesat

 

 

Regulatory issues:

 

Periodic Safety Update Report and Risk Manangement Plan

 

Dr. Sonja HrabcikCASE_PHVagesat

 

Communication (incl. DHCP, Educational Material) und Implementation

 

Mag. Rudolf Schranzpv-implementationagesat

 

Availability of all AGES/MEA employees

Praise and criticism

For complaints or positive feedbacks to activities of the BASG and AGES MEA or its staff members, please contact us by e-mail lob_und_tadelagesat. You will receive a response usually within five working days.

Created: 19.03.2009 | Page last modified: 14.02.2017

© Austrian Federal Office for Safety in Health Care
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