BfArM recommends that a cover letter signed by the sponsor or a representative of the sponsor be submitted with each application, highlighting the specifics of the clinical investigation and referencing the relevant information in other documents. An accompanying letter should also be submitted for each subsequent submission.

The cover letters can be uploaded e.g. as other type/anderer Typ (AT) via the DIMDI database system.

Unfortunately, it is not possible to have application documents reviewed before the actual approval procedure. A binding statement as to whether the clinical investigation plan meets the requirements can therefore only be made after detailed assessment in the course of the approval procedure.

However, the BfArM offers scientific advice procedures for the pharmaceutical and medical device sectors where certain questions of content can be discussed and recommendations for further action can be given before an application is submitted. Such consultations are subject to fees.