With the introduction of the new EU Legislation in 2012, RMP requirements have changed significantly, triggering content- and process-related changes. An RMP is written as part of a submission dossier and is submitted for assessment to the EMA. The most important information is outlined in Part VI of the RMP, which forms the basis for the summary that is subsequently published on the EMA website. For medical writers the task of writing for expert and lay audiences at the same time poses new challenges.