How to contact us

Office hours and customers service

Pursuant to § 13 para 5 of the General Administrative Procedure Act 1991, the following office hours and customer service are announced for the Federal Office for Safety in Health Care:

Monday until Thursday9.00 - 15.00 h
Friday9.00 - 12.00 h

Notes on enquiries

  • Prior to contacting us, please visit our website for detailed information, 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

Functional E-Mail Addresses

SubjectE-Mail
Active Substance Master File (ASMF, EDMF)asmf@basg.gv.at 
Analytics - chemical-pharmaceuticalbasg.cpaa@basg.gv.at
Analytics - biological (batch releases)chargen@basg.gv.at
Biologicsbpsa_bioq@basg.gv.at
Boderline and classification issuesabgrenzung@basg.gv.at
BREXIT questions and applicationrms@basg.gv.at
Centralised Procedures (Scientific Office)scio@basg.gv.at
Certificate of a Pharmaceutical Productcpp@basg.gv.at
CESP - technical issuescesp@basg.gv.at
Clinical trials on medicinal productsclinicaltrials@basg.gv.at
Clinical trials on medical devices clinicaltrials@basg.gv.at
Compassionate usecompassionate-use@basg.gv.at
Dunning activities, due datesbasg.mahnungen@basg.gv.at
DHPC and education materialdhpc-em@basg.gv.at
eAF - regulatory questionsbasg-cms@basg.gv.at
eAF general topicsgeorg.neuwirther@ages.at
Electronic submission (inquiries and technical validation)eSubmission@basg.gv.at
Enforcementenforcement@basg.gv.at
ERP European Reference Product inquiries  (AT not RMS)hotline.euregulatory@basg.gv.at
eServices - technical issuesbasg-eservices@basg.gv.at
Fee and invoice issuesbasg.fakturierung@basg.gv.at
Free Sales Certificate for medical devicesfsc@basg.gv.at
GLP Good Laboratory Practiceglp@basg.gv.at
Haemovigilancehaemoviglianz@basg.gv.at
Herbal medicinesbasg-heve@basg.gv.at
Homeopathic medicinesbasg-heve@basg.gv.at
Innovative medicinal productsinnovation@basg.gv.at
Inquiries (general)basg_anfragen@basg.gv.at
Inspectionsinspektionen@basg.gv.at
Inspections of bioequivalence studiesgcp-be@basg.gv.at
Inspections of computer-based systemsgxp-cgs@basg.gv.at
Inspections according to GLPglp@basg.gv.at
Medical devicesmedizinprodukte@basg.gv.at
Medicine shortagesmedicineshortage@basg.gv.at
Naming AT=RMSrms@basg.gv.at
Naming AT=CMS and nationalhotline.euregulatory@basg.gv.at
National Scientific Advice (NASA)scientificadvice@basg.gv.at
Non-interventional studies (NIS)nis@basg.gv.at
Paediatric worksharing Art 45 and 46kinderarzneimittel@basg.gv.at
Parallel importreference@basg.gv.at
PDF technical issueshttps://servicedesk.ema.europa.eu
Pharmacovigilance - humanpharm-vigilanz@basg.gv.at
Pharmacovigilance - veterinarybasg-v-phv@basg.gv.at
Pharmacovigilance PHV implementationpv-implementation@basg.gv.at
Pipeline meeting - contactbasg-agesmedizinmarktaufsicht@basg.gv.at
PMF - Plasma Master Filepmf@basg.gv.at
Praise or criticismlob_und_tadel@basg.gv.at
PSUR and MRPCASE_PHV@basg.gv.at
Public Relationspresse-basg@basg.gv.at
QRD inquiriesqrd@basg.gv.at
Quality deficiency reportsam-qualitaetsmangel@basg.gv.at
Quality management of the Austrian Medicines and Medical Devices Agencyqmgt@basg.gv.at
Reference product AT=RMSrms@basg.gv.at
Regulatory, general inquirieshotline.euregulatory@basg.gv.at
Regulatory, product-related AT=RMSrms@basg.gv.at
Regulatory, product-related AT=CMSbasg-cms@basg.gv.at
Regulatory, product-related, national in ATnat@basg.gv.at
Regulatory issues - central procedurecp@basg.gv.at
Scientific Advice (ATTENTION! For drug developers only)scientificadvice@basg.gv.at
Side effects - reporting on human medicinesnebenwirkung@basg.gv.at
Sunset clausee-Service-Portal
Tissue-vigilancegewebevigilanz@basg.gv.at
Veterinary medicines - assessmentbasg-heve@basg.gv.at

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

lcm@ages.at

Traisengasse 5, 1200 Wien

Regulatory issues

General enquiries:hotline.euregulatory@basg.gv.at
Regulatory, product-related AT=RMS:rms@basg.gv.at
Regulatory, product-related AT=CMS:basg-cms@basg.gv.at
Regulatory, product-related, national in AT:nat@basg.gv.at

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

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

DI Susanne Stottersusanne.stotter@ages.at
DI Dr. Wolfgang Herzogwolfgang.herzog@ages.at


* 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 Productsin Department HEVE
 

Univ.-Doz. Dr. Reinhard Längerreinhard.laenger@ages.at
Dr. Astrid Obmannastrid.obmann@ages.at

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

Dr. Ingeborg Gerngrossingeborg.gerngross@ages.at
Dr. Jascha Hörnischjascha.hoernisch@ages.at

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

Dr. Gabriele Rothmüllergabriele.rothmueller@ages.at
Mag. Ingrid Langneringrid.langner@ages.at

Institute Assessment & Analytics (BGA)

Head: Dr. Gerhard Beck

chargen@ages.at

Assessment - Traisengasse 5, 1200 Wien


Medical assessment of human medices in Department CASE 

Dr. Barbara Tucekbarbara.tucek@ages.at
Dr. Jan Neuhauserjan.neuhauser@ages.at

 

Centralised procedures 

Dr. Jan Neuhauserjan.neuhauser@ages.at

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

Dr. Brigitte Müllerbrigitte.mueller@ages.at

 

Pharmacovigilance

Dr. Barbara Tucekpharm-vigilanz@basg.gv.at

 

Biologicals, Preclinical and Statistical Assessment

Dr. Günter Waxeneckerguenter.waxenecker@ages.at

OMCL Laboratory - Possingergasse 38, 1160 Wien

Analytics biological medicines 

Dipl.-Ing. Heidemarie Schindlchargen@basg.gv.at

 

OMCL Laboratory - Spargelfeldstraße 191, 1220 Wien

Analytics  chemical-pharmaceutical medicines

Mag. Roman Macasbasg.cpaa@basg.gv.at
Austrian Pharmacopoeiabasg.oeab@basg.gv.at

Institute Surveillance (INS)

Head: Dipl.- Ing. Dr. Ronald Bauer

inspektionen@basg.gv.at

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-vigilanz@basg.gv.at
Fax.Nr.:+43 (0)50 555 36207

 

Pharmacovigilance veterinary medicines

Dr. Anja Kotschwarbasg-v-phv@basg.gv.at

Regulatory issues:

Periodic Safety Update Report and Risk Manangement Plan

Dr. Sonja HrabcikCASE_PHV@basg.gv.at

 

Pharmacovigilance Implementation / DHCP and Educational Material

Dr. Ulrike Rehbergerpv-implementation@basg.gv.at
Mag. Rudolf Schranzdhpc-em@basg.gv.at

Availability of all 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_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

Email

Further inquiry note