Templates

• Risk Management Plan (RMP) (Word file) (German only)
  Risk Management Plan (RMP) (pdf file) (German only)
  An RMP is required to receive approval. Its purpose is to provide an overview of the product and its risks.
• Periodic safety report (PSUR) (German only)
  In accordance with section 63i subsection 4 of the AMG, the higher federal authority can request a PSUR. These reports must be submitted on a regular basis depending on the applicable conditions, in most cases annually. A PSUR should provide an overview of the adverse events that have occurred in the period of time covered in the report in order to contribute to the assessment of the product's benefit-risk ratio.
• ATMP Pharmacovigilance System (German only)
  The marketing authorisation holder must provide details on the establishment of a pharmacovigilance system. This document must be submitted in the approval application.