The request for advice should be made in writing using the following application form:
- Application Form (file size: 201 KB)
Use of the application form is absolutely necessary in order to ensure that the relevant information for a valid request is provided at the time of initial submission. Detailed information on how to fill out the application form is summarised in the "Guidance for Applicants“.
A concrete and precise List of Questions should be provided as an appendix to the application form using the following template:
- Appendix Questions (file size: 64 KB)
The applicant should present a position and – if applicable – a justification for each question. At the time of initial application the list of questions should be indicated as version 1; in case of subsequent amendments/corrections the versions should be numbered consecutively.
Prior to the meeting, BfArM expects a list of participants from the applicant. Positions/functions of the individual attendees should be listed. A draft of this list should be included in the initial application in order to ensure adequate participation of experts from the Institute. The final list should be provided at least 1 week prior to the actual meeting date. The following template should be used:
- Appendix Participants (file size: 79 KB)
Requests for Scientific and Regulatory Advice should be sent sixfold (including application form and list of questions) to the following address:
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)