How to contact us

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

Media enquiries relating activities including press releases, press articles and interviews:     

presse-basg@basg.gv.at

 

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)asmfbasg.gvat 
Analytics - chemical-pharmaceuticalbasg.cpaabasg.gvat
Analytics - biological (batch releases)chargenbasg.gvat
Biologicsbpsa_bioqbasg.gvat
Boderline and classification issuesabgrenzungbasg.gvat
BREXIT questions and applicationrmsbasg.gvat
Centralised Procedures (Scientific Office)sciobasg.gvat
Certificate of a Pharmaceutical Productcppbasg.gvat
CESP - technical issuescespbasg.gvat
Clinical trials on medicinal productsclinicaltrialsbasg.gvat
Clinical trials on medical devices clinicaltrialsbasg.gvat
Compassionate usecompassionate-usebasg.gvat
Dunning activities, due datesbasg.mahnungenbasg.gvat
DHCP and education material pv-implementationbasg.gvat
Electronic submission (inquiries and technical validation)eSubmissionbasg.gvat
Enforcementenforcement@basg.gv.at
ERP European Reference Product inquiries  (AT not RMS)hotline.euregulatorybasg.gvat
eServices - technical issues basg-eservicesbasg.gvat
Fee and invoice issuesbasg.fakturierungbasg.gvat
Free Sales Certificate for medical devicesfscbasg.gvat
GLP Good Laboratory Practiceglpbasg.gvat
Haemovigilancehaemoviglianzbasg.gvat
Herbal medicinesbasg-hevebasg.gvat
Innovative medicinal productsinnovationbasg.gvat
Inquiries (general)basg_anfragenbasg.gvat
Inspectionsinspektionenbasg.gvat
Inspections of bioequivalence studiesgcp-bebasg.gvat
Inspections of computer-based systemsgxp-cgsbasg.gvat
Inspections according to GLPglpbasg.gvat
Medical devicesmedizinproduktebasg.gvat
Medicine shortagesmedicineshortagebasg.gvat
Naming AT=RMSrmsbasg.gvat
Naming AT=CMS and national hotline.euregulatorybasg.gvat
National Scientific Advice (NASA)scientificadvicebasg.gvat
Non-interventional studies (NIS)nisbasg.gvat
Paediatric worksharing Art 45 and 46kinderarzneimittelbasg.gvat
Parallel importreferencebasg.gvat
Pharmacovigilance - humanpharm-vigilanzbasg.gvat
Pharmacovigilance - veterinary basg-v-phvbasg.gvat
Pharmacovigilance PHV implementationpv-implementationbasg.gvat
Pipeline meeting - contactbasg-agesmedizinmarktaufsichtbasg.gvat
PMF - Plasma Master Filebasg.gv.at
Praise or criticismlob_und_tadelbasg.gvat
PSUR and MRPCASE_PHVbasg.gvat
Public Relationspresse-basg@basg.gv.at
QRD inquiriesqrdbasg.gvat
Quality deficiency reportsam-qualitaetsmangelbasg.gvat
Quality management of the Austrian Medicines and Medical Devices Agencyqmgtbasg.gvat
Reference product AT=RMSrmsbasg.gvat
Regulatory, general inquirieshotline.euregulatorybasg.gvat
Regulatory, product-related AT=RMS rmsbasg.gvat
Regulatory, product-related AT=CMSbasg-cmsbasg.gvat
Regulatory, product-related, national in ATnatbasg.gvat
Regulatory issues - central procedurecpbasg.gvat
Scientific Advicescientificadvicebasg.gvat
Side effects - reporting on human medicinesnebenwirkungbasg.gvat
Sunset clausee-Service-Portal
Tissue-vigilancegewebevigilanzbasg.gvat
Veterinary medicines - assessmentbasg-hevebasg.gvat

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.euregulatorybasg.gvat
Regulatory, product-related AT=RMS:rmsbasg.gvat
Regulatory, product-related AT=CMS:basg-cmsbasg.gvat
Regulatory, product-related, national in AT:natbasg.gvat

 

 

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-vigilanzbasg.gvat

 

Biologicals, Preclinical and Statistical Assessment

 

Dr. Barbara Zemannbarbara.zemannagesat
Dr. Günter Waxeneckerguenter.waxeneckeragesat

 

 


OMCL Laboratory - Possingergasse 38, 1160 Wien

 

Analytics biological medicines 

 

Dipl.-Ing. Heidemarie Schindlchargenbasg.gvat

OMCL Laboratory - Zimmermanngasse 3, 1090 Wien

 

Analytics  chemical-pharmaceutical medicines

 

Mag. Roman Macasbasg.cpaabasg.gvat
Austrian Pharmacopoeiabasg.oeabbasg.gvat

Institute Surveillance (INS)

Head: Dipl.- Ing. Dr. Ronald Bauer

 

 

inspektionenbasg.gvat

Traisengasse 5, 1200 Wien

Departments for 

 

GMP/GDPMag. Andreas Kraßnigg
Clinical trials Dr. Ilona Reischl
Medical Devices Market Surveillance 
Dipl.-Ing. Andreas Amon
Blood, Tissue & VigilanceMag. Dr. Verena Plattner

Pharmacovigilance contacts

 

Reports: 

 

Single case and signal detection of human medicines

 

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

 

Pharmacovigilance veterinary medicines

 

Mag. Brigitte Hauserbasg-v-phvbasg.gvat

 

 

Regulatory issues:

 

Periodic Safety Update Report and Risk Manangement Plan

 

Dr. Sonja HrabcikCASE_PHV@basg.gv.at

 

Implementation of PHV issues / DHCP and Educational Material

 

Mag. Rudolf Schranzpv-implementationbasg.gvat

 

Availability of all AGES/MEA employees Neu

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_tadel@basg.gv.at.

Incoming complaints are checked if they are in the responsibility of the Federal Office for Safety in Health Care (BASG) or the Austrian Medicines and Medical Devices Agency (AGES MEA). You will receive on short notice feedback on the outcome of this check as well as information regarding the actions implemented following justified complaints in our responsibility, as applicable.

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

  

Created: 19.03.2009 | Page last modified: 14.11.2018

© Austrian Federal Office for Safety in Health Care
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