Contact persons
updated: 2013.05.16
Contact persons at the BfArM for EU and ICH Committees
List of contact persons at the BfArM for EU and ICH Committees
Contact persons at the BfArM
| Inquiry - keyword | Product range | Responsibility | Internal staff identification number |
|---|---|---|---|
| Demarcation from | Drugs - Cosmetics;Drugs - Food;Biocides; Classification of applications according to Section 21 sub-section 4 German Medicines Act (AMG) | Dr. Kerstin Stephan | 11.1.03 |
| Medical Devices - Other Products | Dr. Wolfgang Lauer | 9 | |
| BfArM / PEI | Dr. Brigitte Brake | 35 | |
| AMG-EV / Hotline | Electronic submission procedure according to AMG-EV (problem analysis, assistances) | amg-ev.hotline | 66.2.02 |
| Variations | national | Dr. Günter Omlor | 12.1 |
| European (DCP/MRP) | Susanne Winterscheid | 31 | |
| European (CP) | Susanne Winterscheid | 31 | |
| Narcotics | general questions | Dr. Wilhelm Schinkel | 82 |
questions concerning drug-prescribing regulation - BtMVV | preferably Mo-Fr 9-12 Uhr Hotline Tel. +49 228/207 4321 | 84 | |
| Excipients Guideline | Dr. Klaus Menges | P23 | |
| Biotechnology (specific questions) | Dr. Brigitte Brake | 35 | |
| Bioavailability/Bioequivalence - Waiving of studies (Biowaiver) / Performance/Design of studies | Dr. Henrike Potthast | 52.04 | |
| Counterfeiting of drugs | Dr. Axel Thiele | 75 | |
| Data protection | Florian Dexel | Z161DSB | |
| Active Substance Master File (ASMF) | 11.02 | ||
| Duplicate Applications | 11.04.05 | ||
| German freedom of information act | Andrea Dercks-Müller | 11.1.02 | |
| Processing number | application, response | preferably by Fax No.: | Z14.1 |
| Renewals (MR-, DC and central procedures) | Dr. Brigitte Hammes | 31.13 | |
| Renewals (pure national) | Gabriele Eibenstein | 13 | |
| Precursors (in general) | 81 | ||
| Inquiries not relating to procedures | Efficacy | Dr. Klaus Menges | P23 |
| Pharmaceutical Quality | Dr. Usfeya Muazzam | P23.03 | |
| Toxicology | PD Dr. Elke Röhrdanz | 25 | |
| Childproof Packaging | Dr. Axel Thiele | 75 | |
| Clinical Trials of Medicinal Products | Dr. Dr. Andreas Schrödter | 61 | |
| Consultation Procedures | Dr. Kerstin Stephan | 11.1.03 | |
| Medical Devices | Dr. Wolfgang Lauer | 9 | |
| MRP/DCP (c.f.: EU Licenses) | Dr. Peter Bachmann | P21 | |
| Master Texts | Musterdatenbank-Coordination/-Administration (specimen text publications in German only) | muster@bfarm.de | 66.2.02 |
| Post-approval Procedures | Gabriele Eibenstein | 13 | |
| Off-label-use | Dr. Claudia Riedel | 63 | |
| Orphan Drugs | Dr. Rembert Elbers | P22 | |
| Package Leaflet | Dr. Klaus Menges | P23 | |
| Parallel Imports | Alexandra von Hagen | 14.03 | |
| Susanne Brendler-Schwaab | 14 | ||
| Herbal and Homoeopathic Drugs | Dr. Werner Knöss | 4 | |
| Paediatric Worksharing | Dr. Birka Lehmann | P2 | |
| Pharmacovigilance | N.N. | 7 | |
| Pharmacovigilance Inspections | Dr. Axel Thiele | 75 | |
| Number of applicant (PNR) | application, response | AMIS-PU@bfarm.de | 11.5.11 |
| Press Office | Maik Pommer | P11 | |
| Referrals | Dr. Axel Thiele | 75 | |
| Risks / Adverse Drug Reactions | N.N. | 7 | |
| Standardised Licenses | Dr. Thomas Zapf | 14.16N | |
| Risk Management Action | Dr. Axel Thiele | 75 | |
| TSE-Conformity Declaration | Dr. Jan Schaefer | 75.03 | |
| Adverse drug reactions: Database registration | Dr. Norbert Paeschke | 76N | |
| Allocation of national procedure numbers | Karl-Heinz Linder | Z14.1 | |
| Inquiries relating to procedures regarding content (efficacy, safety, pharmaceutical quality) | Anaesthesiology, Analgesics (33) | Dr. Janet Schriever | 33N |
| Antiinfective Agents, Antiallergics, Dermatology, Ophthalmology, Otolaryngology (32) | Sibylle Matz | 32N | |
| Biostatistics | Dr. Norbert Benda | 52N | |
| Biotechnology, Pharmaceutical Inspections Quality (35) | Dr. Brigitte Brake | 35N | |
| Endocrinology (24) | Dr. Ulrike Hermes | 24 | |
| Gastroenterology (22) | Dr. Ralf Meyer | 22 | |
| Genetic and Reproductive Toxicology (25) | PD Dr. Elke Röhrdanz | 25 | |
| Cardiology, Antidiabetics (23) | Dr. Martina Weise | 23 | |
| Pneumology (33) | Dr. Janet Schriever | 33 | |
| Homoeopathic and Anthroposophic Drugs (43) | Christine Werner | 43 | |
| Neurology and Psychiatry (34) | Dr. Lucas Rems | 34 | |
| Oncology (24) | Dr. Ulrike Hermes | 24 | |
| Herbal and Traditional Drugs (42) | Klaus Reh | 42 | |
| Radiology (22) | Dr. Ralf Meyer | 22 | |
| Rheumatology (33) | Dr. Janet Schriever | 33 | |
| Inquiries relating to procedures (regulatory content) | Validation | Markus Piek | 11.4.05 |
| Cardiology; Endocrinology; Gastroenterology; Genetic and Reproductive Toxicology; Oncology; Immunology and Haematology; Radiology (Licensing 2) | Martin Norta | 21 | |
| Anaestesiology, Analgesics; Antiinfectives; Dermatology; Neurology and Psychiatry; Pneumology; Ophthalmology; Otolaryngology and Rheumatology (Licensing 3) | Susanne Winterscheid | 31 | |
| Herbal and Traditional Medicinal Products; Homoeopathic and Anthroposophic Medicinal Products (Licensing 4) | Dr. Martin Diller | 41 | |
| Renewal of authorisations | National | Mariela Becker | 12 |
| European | Dr. Brigitte Hammes | 31.13 | |
| Expert Advisory Committee for Prescription-Only Issues | Dr. Ute Brixius | 74 | |
| Legal status | Dr. Ute Brixius | 74 | |
| Scientific Advice | Dr. Petra Dejas-Eckertz | 62 | |
| Sunset-Clause-Procedure | Dr. Michael Horn | 1 | |
| Authorisation of medicinal products in general | Dr. Michael Horn | 1 | |
| National Authorisation Procedures | Markus Piek | 11.4.05 | |
| EU Licenses | decentralised (DCP/MRP) | Dr. Peter Bachmann | P21 |
| centralised (CP) | Dr. Sabine Mayrhofer | P2.01 |