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: basg@basg.gv.at
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 Thursday | 9.00 - 15.00 h |
| Friday | 9.00 - 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 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
| Subject | |
|---|---|
| Inquiries (general) | basg_anfragen@basg.gv.at |
| Active Substance Master File (ASMF, EDMF) | asmf@basg.gv.at |
| Analytics - chemical-pharmaceutical | basg.cpaa@basg.gv.at |
| Analytics - biological (batch releases) | chargen@basg.gv.at |
| Antibiotics flow | ab-mengenstrom@ages.at |
| Boderline and classification issues | abgrenzung@basg.gv.at |
| BREXIT questions and application | rms@basg.gv.at |
| Certificate of a Pharmaceutical Product | cpp@basg.gv.at |
| CESP - technical issues | cesp@basg.gv.at |
| Clinical trials on medicinal products | clinicaltrials@basg.gv.at |
| Clinical trials on medical devices | clinicaltrials@basg.gv.at |
| Compassionate use | compassionate-use@basg.gv.at |
| Data protection | datenschutz@basg.gv.at |
| Dunning activities, due dates | basg.mahnungen@basg.gv.at |
| DHPC and education material | dhpc-em@basg.gv.at |
| eAF - regulatory questions | basg-cms@basg.gv.at |
| eAF general topics | basg-eservices@basg.gv.at |
| Editorial questions | redaktion-basg@basg.gv.at |
| Electronic submission (inquiries and technical validation) | eSubmission@basg.gv.at |
| Enforcement | enforcement@basg.gv.at |
| Environmental Risk Assessment (ERA) human | era.human@basg.gv.at |
| Environmental Risk Assessment (ERA) veterinary | basg-heve@basg.gv.at |
| ERP European Reference Product inquiries (AT not RMS) | hotline.euregulatory@basg.gv.at |
| eServices - technical issues | basg-eservices@basg.gv.at |
| Fee and invoice issues | basg.fakturierung@basg.gv.at |
| Free Sales Certificate for medical devices | fsc@basg.gv.at |
| GLP Good Laboratory Practice | glp@basg.gv.at |
| Haemovigilance | haemoviglianz@basg.gv.at |
| Herbal medicines | basg-heve@basg.gv.at |
| Homeopathic medicines | basg-heve@basg.gv.at |
| Infrastruktursicherungsbeitrag (ISB) | infrastruktursicherungsbeitrag@basg.gv.at |
| Innovative medicinal products | innovation@basg.gv.at |
| Inspections | inspektionen@basg.gv.at |
| Inspections of bioequivalence studies | gcp-be@basg.gv.at |
| Inspections according to GLP | glp@basg.gv.at |
| Medical devices | medizinprodukte@basg.gv.at |
| Medical device incident report form | Medical device incident report form |
| Medicine shortages | medicineshortage@basg.gv.at |
| Naming AT=RMS | rms@basg.gv.at |
| Naming AT=CMS and national | hotline.euregulatory@basg.gv.at |
| National Scientific Advice (NASA) | scientificadvice@basg.gv.at |
| ÖAB Pharmacopoeia | basg.oeab@basg.gv.at |
| Paediatric worksharing Art 45 and 46 | kinderarzneimittel@basg.gv.at |
| Parallel import | reference@basg.gv.at |
| PDF technical issues | https://servicedesk.ema.europa.eu |
| Pharmacovigilance - human | pharm-vigilanz@basg.gv.at |
| Pharmacovigilance - veterinary | basg-v-phv@basg.gv.at |
| Pharmacovigilance PHV implementation | pv-implementation@basg.gv.at |
| Praise or criticism | lob_und_tadel@basg.gv.at |
| Public Relations | presse-basg@basg.gv.at |
| QRD inquiries | qrd@basg.gv.at |
| Quality deficiency reports | am-qualitaetsmangel@basg.gv.at |
| Quality management of the Austrian Medicines and Medical Devices Agency | qmgt@basg.gv.at |
| Reference product AT=RMS | rms@basg.gv.at |
| Regulatory, general inquiries | hotline.euregulatory@basg.gv.at |
| Regulatory, national PHYTO HOM | nat-herb-hom@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 |
| Regulatory issues - central procedure | cp@basg.gv.at |
| Scientific Advice (ATTENTION! For drug developers only) | scientificadvice@basg.gv.at |
| Side effects - reporting on human medicines | nebenwirkung@basg.gv.at |
| Stockpiling | bevorratung@basg.gv.at |
| Sunset clause | e-Service-Portal |
| Tissue-vigilance | gewebevigilanz@basg.gv.at |
| Veterinary medicines - assessment | basg-heve@basg.gv.at |
BASG - Federal Office for Safety in Health Care
| Office of BASG | Head: 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 Management | Head: Mag. Dr. Peter Platzer |
| Institute Assessment & Analytics | Head: Dr. Gerhard Beck |
| Institute Surveillance | Head: Dipl.-Ing. Dr. Ronald Bauer |
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 | chargen@basg.gv.at |
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 | inspektionen@basg.gv.at |
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 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 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.
