How to contact us

Federal Office for Safety in Health Care (BASG - Bundesamt für Sicherheit im Gesundheitswesen) 

Austrian Medicines and Medical Devices Agency (AGES MEA - AGES Medizinmarktaufsicht)

Traisengasse 5
A-1200 Vienna
Tel.: 050 555-36111
Tel.: +43 (0)50 555-36111
E-Mail: [email protected]

Office hours and customers service

Pursuant to Section 13(5) of the General Administrative Procedures Act 1991, the following official hours and times designated for the communication of parties (by prior appointment) 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 and personal contact please use email adressed with [email protected]. 

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.
  • InfoTool on the Reimbursement Code: In this database of the Main Association of Austrian Social Insurance you will find information, e.g. on the active ingredient, pack size, price and reimbursement conditions of all medicines listed in the Reimbursement Code of the Austrian Social Insurance. The data is updated monthly. This database offers clear comparisons of pharmaceutical specialities with the same or similar active ingredients.

 Media Related Contacts

Media enquiries relating activities including press releases, press articles and interviews: [email protected]

Functional E-Mail Addresses

SubjectE-Mail
Inquiries (general)[email protected]
Active Substance Master File (ASMF, EDMF)[email protected] 
Analytics - chemical-pharmaceutical[email protected]
Analytics - biological (batch releases)[email protected]
Antibiotics flow[email protected]
Boderline and classification issues[email protected]
BREXIT questions and application[email protected]
Certificate of a Pharmaceutical Product[email protected]
CESP - technical issues[email protected]
Clinical trials on medicinal products[email protected]
Clinical trials on medical devices [email protected]
Compassionate use[email protected]
Data protection[email protected]
Dunning activities, due dates[email protected]
DHPC and education material[email protected]
eAF - regulatory questions[email protected]
eAF general topics[email protected]
Editorial questions[email protected]
Electronic submission (inquiries and technical validation)[email protected]
Enforcement[email protected]
Environmental Risk Assessment (ERA) human[email protected]
Environmental Risk Assessment (ERA) veterinary[email protected]
ERP European Reference Product inquiries  (AT not RMS)[email protected]
eServices - technical issues[email protected]
Fee and invoice issues[email protected]
Free Sales Certificate for medical devices[email protected]
GLP Good Laboratory Practice[email protected]

Haemovigilance

Emergency Contact

[email protected]

+43 (0) 664 831 28 43

Herbal medicines[email protected]
Homeopathic medicines[email protected]
Infrastruktursicherungsbeitrag (ISB)[email protected]
Innovative medicinal products[email protected]
Inspections[email protected]
Inspections of bioequivalence studies[email protected]
Inspections according to GLP[email protected]
Medical devices[email protected]
Medical device incident report formMedical device incident report form
Medicine shortages[email protected]
Naming AT=RMS[email protected]
Naming AT=CMS and national[email protected]
National Scientific Advice (NASA)[email protected]
ÖAB Pharmacopoeia[email protected]
Paediatric worksharing Art 45 and 46[email protected]
Parallel import[email protected]
PDF technical issueshttps://servicedesk.ema.europa.eu

Pharmacovigilance - human

 

[email protected]

online reporting of side effects human

Pharmacovigilance - veterinary

 

[email protected]

online reporting of side effects veterinary

Pharmacovigilance PHV implementation[email protected]
Praise or criticism[email protected]
Public Relations[email protected]
QRD inquiries[email protected]
Quality deficiency reports[email protected]
Quality management of the Austrian Medicines and Medical Devices Agency[email protected]
Reference product AT=RMS[email protected]
Regulatory, general inquiries[email protected]
Regulatory, national PHYTO HOM[email protected]
Regulatory, veterinary[email protected]
Regulatory, product-related AT=RMS[email protected]
Regulatory, product-related AT=CMS[email protected]
Regulatory, product-related, national in AT[email protected]
Regulatory issues - central procedure[email protected]
Scientific Advice (ATTENTION! For drug developers only)[email protected]
Side effects - reporting on human medicines[email protected]
Stockpiling[email protected]
Sunset clausee-Service-Portal
UPD - Union Product Database contact point[email protected]

Tissue-vigilance

Emergency Contact

[email protected]

+43 (0) 664 831 28 43

Veterinary medicines - assessment[email protected]

BASG - Federal Office for Safety in Health Care

Office of BASGHead: Mag. iur. Thomas Reichhart

AGES MEA - Austrian Medicines and Medical Devices Agency, Traisengasse 5, 1200 Wien

AGES MEA               Head: Dipl.-Ing. Dr. Günter Waxenecker, MDRA

Institutes of AGES MEA:

Institute Marketing Authorisation of Medicinal Products & Lifecycle ManagementHead: Mag. Dr. Peter Platzer
Institute Assessment & AnalyticsHead: Dr. Gerhard Beck
Institute SurveillanceHead: Dipl.-Ing. Dr. Ronald Bauer

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

Head: Mag. Dr. Peter Platzer                           [email protected]

Regulatory Affairs (REGA)

Head: Mag. Alexander Ertl

Medical Assessment (MRAT)

Head: Dr. Ingeborg Gerngroß

  • Medical evaluation of national, MRP and DCP procedures for human medicinal products (except biologics, herbal medicinal products)

Quality Assessment Medicinal Products (QUAL)

Head: Mag. Gernot Hirn

  • Quality assessment of human and veterinary medicinal products (chemical, certain biologics*)

* such as heparin, low molecular weight heparins, insulin, pancreatin, menotrophin, botulinum toxin, hyaluroidase, enzymes/lysates of microorganisms, Lactobacillus spp., Streptococcus spp., phospholipid fraction from bovine/pig lungs (see also CMDh Overview of biological active substances of non-recombinant origin)

Herbal, Homoeopathic & Veterinary Medicinal Products (HEVE)

Head: Dipl.-Ing. Haru Kroneis, MSc Tox

  • Medical and quality assessment of herbal medicinal products and homeopathic remedies
  • Medical evaluation of national, MRP and DCP procedures for veterinary medicinal products

Institute Assessment & Analytics (BGA)

Head: Dr. Gerhard Beck[email protected]

Analytics of Biological Medicinal Products (BAMA)

OMCL Laboratory - Possingergasse 38, 1160 Wien

Head: Dipl.-Ing. Heidemarie Schindl

Analytics of Chemical-pharmaceutical Medicinal Products (CPAA)

OMCL Laboratory - Spargelfeldstrasse 191, 1220 Wien

Head: Mag. Roman Macas

Clinical Assessment of Safety & Efficacy (CASE)

Clinical assessment for human medicinal products in the centralized procedure, biologics (also national and MRP/DCP), scientific advice.

Head: Dr. Barbara Tucek, MSc

Biologicals, Preclinical & Statistical Assessment (BPSA)

Head: Dipl.-Ing. Dr. Manfred Schuster, MSc

Assessment Pharmacovigilance (APHV)

Head: Dr. Jan Neuhauser

Institute Surveillance (INS)

Head: Dipl.- Ing. Dr. Ronald Bauer[email protected]

Good Manufacturing Practice (GMDP)

Head: Mag. Andreas Kraßnigg

Enforcement, Medicine Shortages & Quality Defects (EVEQ)

Head: Mag. Martina Unteregger

Clinical Trials (CLTR)

Head: Dr. Stefan Strasser

Medical Devices Market Surveillance (MDVI)

Head: Dr. Matthias Scherer

Blood, Tissue & Vigilance (BTVI)

Head: Mag. Dr. Verena Plattner

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 [email protected].

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 Tel.: +43 (0) 664 831 28 43, Fax.: +43 (0)50 555-36408

Please note: The emergency number should only be used for emergencies according to Art. 10 of the Austrian Pharmacovigilance Regulation or Art. 40 of the Austrian Medical Devices Act 2021. 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.

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