How to contact us New
Federal Office for Safety in Health Care (BASG)
Austrian Medicines and Medical Devices Agency (MEA)
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 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
Subject | |
---|---|
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 |
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 | |
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 |
Electronic submission (inquiries and technical validation) | eSubmission@basg.gv.at |
Enforcement | enforcement@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 |
Inquiries (general) | basg_anfragen@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 |
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 | |
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 |
Sunset clause | e-Service-Portal |
Tissue-vigilance | gewebevigilanz@basg.gv.at |
Veterinary medicines - assessment | basg-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. Günter Waxenecker, MDRA
Traisengasse 5, 1200 Wien
Institutes of AGES MEA:
Head | |
Institute Marketing Authorisation of Medicinal Products & Lifecycle Management | Mag. Dr. Peter Platzer |
Institute Assessment & Analytics | Dr. Gerhard Beck |
Institute Surveillance | Dipl.-Ing. Dr. Ronald Bauer |
Institute Marketing Authorisation of Medicinal Products & Lifecycle Management (LCM)
Head: Mag. Dr. Peter Platzer
lcm@basg.gv.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*)
Mag. Gernot Hirn |
Dipl.-Ing. Dr. Wolfgang Herzog |
MMag. Dr. Elisabeth Strutzmann |
* 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
Dipl.-Ing. Haru Kroneis, MScTox | basg-heve@basg.gv.at |
Dr. Astrid Obmann | basg-heve@basg.gv.at |
Institute Assessment & Analytics (BGA)
Head: Dr. Gerhard Beck
chargen@basg.gv.at |
Assessment - Traisengasse 5, 1200 Wien
Medical assessment of human medices in Department CASE
Dr. Barbara Tucek | |
Mag. Daniela Philadelphy |
Pharmacovigilance
Dr. Jan Neuhauser | pharm-vigilanz@basg.gv.at |
Biologicals, Preclinical and Statistical Assessment
Dipl.-Ing. Dr. Manfred Schuster, MSc |
OMCL Laboratory - Possingergasse 38, 1160 Wien
Analytics biological medicines
Dipl.-Ing. Heidemarie Schindl | chargen@basg.gv.at |
OMCL Laboratory - Spargelfeldstraße 191, 1220 Wien
Analytics chemical-pharmaceutical medicines
Mag. Roman Macas | basg.cpaa@basg.gv.at |
Austrian Pharmacopoeia | basg.oeab@basg.gv.at |
Institute Surveillance (INS)
Head: Dipl.- Ing. Dr. Ronald Bauer
inspektionen@basg.gv.at |
Traisengasse 5, 1200 Wien
Departments for
GMP/GDP | Mag. Andreas Kraßnigg |
Enforcement, Medicine Shortages & Quality Defects | Mag. Martina Unteregger |
Clinical trials | Dr. Stefan Strasser |
Medical Devices Market Surveillance | Dr. Matthias Scherer |
Blood, Tissue & Vigilance | Mag. Dr. Verena Plattner |
Pharmacovigilance contacts
Reports:
Single case and signal detection of human medicines
Mag. Katharina Weber | pharm-vigilanz@basg.gv.at |
Fax.Nr.: | +43 (0)50 555 36207 |
Pharmacovigilance veterinary medicines
Dr. Anja Kotschwar | basg-v-phv@basg.gv.at |
Regulatory issues:
Periodic Safety Update Report and Risk Manangement Plan
Dr. Sonja Hrabcik | pharm-vigilanz@basg.gv.at |
Pharmacovigilance Implementation / DHCP and Educational Material
Dr. Ulrike Rehberger | pv-implementation@basg.gv.at |
Mag. Rudolf Schranz | dhpc-em@basg.gv.at |
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
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.