Contact persons for licensing of medicinal products
Demarcation between medicinal products and other product groups
In Germany, the authorities of the "Länder" are responsible and appointed for the classification of medicinal products. As a rule, this will be done there by the respective district governments ("Bezirksregierung") or regional councils ("Regierungspräsidium") (e.g. departments/divisions for medicinal products, pharmaceutics or such). For a list of the competent "Land" authorities please refer to the website of the Central Authority of the "Länder" for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten): www.zlg.de
For inquiries regarding the demarcation between medicinal products and other product groups addressed to the BfArM, please use our contact form.
Government officials are kindly requested to use the following address:
abgrenzung-arzneimittel@bfarm.de
Inquiries regarding ongoing procedures
As a rule, the BfArM expressly requests refraining from making inquiries during the assessment phase. However, should this become necessary in individual cases, please get in touch with the project manager in charge (if known) or use the BfArM's contact form.
In the case of DCP procedures please also consider the contact addresses published by the CMDh.
Pharmacopoeia
E-Mail:
Arzneibuch@bfarm.de
Telephone: +49 (0)228 99 307-3274
Issuing of WHO Certificates
Upon application, the BfArM issues a certificate corresponding to the World Health Organisation's Certification Scheme for pharmaceutical entrepreneurs located outside the scope of the German Medicinal Products Act (Arzneimittelgesetz, AMG) pursuant to Section 73a sub-section 2 AMG
E-Mail: CPP@bfarm.de
Prior to contacting us please refer to the detailed information on this subject on the BfArM's homepage.
Application for a processing number (Eingangsnummer, ENR)
Application for a processing number (Eingangsnummer, ENR) for a new application for marketing authorisation/registration
E-Mail:
antragseingang@bfarm.de
Telephone: +49-(0)228-99-307-3681
Telefax: +49-(0)228-99-307-3681
Note: Please be sure that your contact data include e-mail address, telefax number, telephone number and address of your company.
Prior to contacting us please refer to the detailed information on this subject on the BfArM's homepage.
National template ("Bescheidmaske")
for DCP applications
E-Mail: translations@bfarm.de
Prior to contacting us please refer to the detailed information on this subject on the BfArM's homepage.
for duplicate applications
E-Mail: nationale-dublette@bfarm.de
Prior to contacting us please refer to the detailed information on this subject on the BfArM's homepage.
Electronic submission of licensing documentation
E-Mail: poststelle@bfarm.de
Prior to contacting us please refer to the detailed information on this subject on the BfArM's homepage.
Result reports of clinical trials pursuant to Section 42b sub-section 1 AMG
Exclusively for inquiries regarding Section 42b sub-section 1 AMG
E-Mail: p42b1@bfarm.de
Prior to contacting us please refer to the detailed information on this subject on the BfArM's homepage.
Clinical trials
E-Mail:
ct@bfarm.de
Telephone: +49 (0)228 99 307-4318
Approval procedures
For issues regarding clinical trials that have been applied for with or authorised by the BfArM please use the following contact details, stating the BfArM submission code (Vorlagenummer):
Telephone.: +49 (0)228 99 307-4318
Telefax: +49 (0)228 99 307-4355
E-mail inquiries should be addressed to: ct@bfarm.de
Parallel imports and parallel distribution
Inquiries regarding parallel imports
E-Mail: Parallelimport@bfarm.de
Inquiries regarding parallel distribution
E-Mail: Parallelvertrieb@bfarm.de
Prior to contacting us please refer to the detailed information on this subject on the BfArM's homepage.
Inquiries from other EU licensing authorities regarding medicinal products licensed in Germany
E-Mail: Composition@bfarm.de
Slot allocation
E-Mail: slotrequest-DCP@bfarm.de
Prior to contacting us please refer to the detailed information on this subject on the BfArM's homepage.
Standard marketing authorisations
E-Mail: e-Standardzulassung@bfarm.de
Prior to contacting us please refer to the detailed information (in German language) on this subject on the BfArM's homepage.
Sunset clause; submission of applications for exception
E-Mail: sunset-clause@bfarm.de
Prior to contacting us please refer to the detailed information on this subject on the BfArM's homepage.
Scientific advice
Kick-off Meeting through the innovation office at the BfArM:
E-Mail:
innovation@bfarm.de
Tel.: +49 (0)228 99 307-4053
Scientific Advice and Pre-submission Meeting, Portfolio Meetings:
E-Mail:
advice@bfarm.de
Tel.: +49 (0)228 99 307-3958