Scientific and Regulatory Advice through the BfArM
The objective of advice procedures is to discuss with the BfArM scientific and regulatory matters regarding the development and licensing of medicinal products and medical devices. In this context applicants have the opportunity to obtain input with regard to questions related to administrative procedures which are in the remit of the BfArM as competent authority.
Applicants can be either pharmaceutical companies or sponsors of clinical trials. Examples for advice are the planning of a clinical development programme for a specific medicinal product or medical device or the legal basis for a forthcoming marketing authorisation application, respectively. Topics which are out of the scope of the above-mentioned administrative procedures are excluded from advice procedures (e.g. recommendations on appropriate treatments).
Advice will be provided upon request only and after justification of the necessity. In principle, advice will only be provided if the questions are not covered by the existing German and European legal texts or if clarification on these texts with regard to a specific question is needed. BfArM neither provides the required development programme nor conducts a preliminary review of a licensing dossier within advice procedures.
In case of further questions regarding advice procedures please contact the following designated persons:
Dr. Petra Dejas-Eckertz
Phone: +49 (0) 228 99 307 3461
E-Mail: Petra.Dejas-Eckertz@bfarm.de
Peggy Beinlich
Phone: +49 (0) 228 99 307 3958
E-Mail: Peggy.Beinlich@bfarm.de
Dr. Christian Behles
Phone: +49 (0) 228 99 307 3296
E-Mail: Cristian.Behles@bfarm.de
The following websites provide Guidance for Applicants, the Application Form and Appendicies (for downloading) as well as current Statistics regarding advice procedures.