In 2015, the EMA Policy 0070 came intoeffect as part of EMA’s commitment toincreased data transparency. In short, clinicalreports included in regulatory applications forexample, marketing authorisations are pub -lished on the EMA web page and therebymade publicly available. Before the clinicalreports can be published, the applicant isrequired by legislation to protect personaldata to ensure individual clinical studyparticipants and other individuals involved inthe study are not identified. The applicant hasto describe how data protection of personaldata has been ensured in an anonymisationreport (AnR). This article describes the diff -er ent steps necessary to prepare an AnR ingeneral, a company’s first experience ofpreparing an AnR for an orphan drug, and thekey points learned from this experience.