MEB 44: Direct Healthcare Professional Communications (DHPCs)

This document is based on the Guideline on Good Pharmacovigilance Practices (GVP) Module XV – Safety communication, and is aimed specifically on the Dutch situation. This document describes the procedure around the implementation of DHPCs in the Netherlands and provides recommendations for the translation of the letter, for determination of the target groups and distribution of the letter. The starting point is that the information in DHPCs should closely reflect to the clinical practice of healthcare professionals, thereby improving the effectiveness of this additional risk minimisation measure.